urn: urn:intuitem:risk:library:ai-act
locale: en
ref_id: AI Act
name: EU Artificial Intelligence Act (AI Act)
description: Regulation (EU) 2024/1689 of the European Parliament and of the Council
  of 13 June 2024 laying down harmonised rules on artificial intelligence and amending
  Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858,
  (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU)
  2020/1828 (Artificial Intelligence Act).
copyright: European Union law
version: 2
publication_date: 2024-05-29
provider: EU
packager: intuitem
objects:
  framework:
    urn: urn:intuitem:risk:framework:ai-act
    ref_id: AI Act
    name: EU Artificial Intelligence Act
    description: Regulation (EU) 2024/1689 of the European Parliament and of the Council
      of 13 June 2024 laying down harmonised rules on artificial intelligence and
      amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU)
      2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU)
      2016/797 and (EU) 2020/1828 (Artificial Intelligence Act).
    requirement_nodes:
    - urn: urn:intuitem:risk:req_node:ai-act:node2
      assessable: false
      depth: 1
      name: Preambule
    - urn: urn:intuitem:risk:req_node:ai-act:recital-1
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 1
      description: "The purpose of this Regulation is to improve the functioning of\
        \ the internal market by laying down a uniform legal framework in particular\
        \ for the development, the placing on the market, the putting into service\
        \ and the use of artificial intelligence systems (AI systems) in the Union,\
        \ in accordance with Union values, to promote the uptake of human centric\
        \ and trustworthy artificial intelligence (AI) while ensuring a high level\
        \ of protection of health, safety, fundamental rights as enshrined in the\
        \ Charter of fundamental rights of the European Union (the \u2018Charter\u2019\
        ), including democracy, the rule of law and environmental protection, against\
        \ the harmful effects of AI systems in the Union, and to support innovation.\
        \ This Regulation ensures the free movement, cross- border, of AI-based goods\
        \ and services, thus preventing Member States from imposing restrictions on\
        \ the development, marketing and use of AI systems, unless explicitly authorised\
        \ by this Regulation."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-2
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 2
      description: This Regulation should be applied in accordance with the values
        of the Union enshrined as in the Charter, facilitating the protection of natural
        persons, undertakings, democracy, the rule of law and environmental protection,
        while boosting innovation and employment and making the Union a leader in
        the uptake of trustworthy AI.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-3
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 3
      description: AI systems  can be easily deployed in a large variety of sectors
        of the economy and many parts of society, including across borders, and can
        easily circulate throughout the Union. Certain Member States have already
        explored the adoption of national rules to ensure that AI is trustworthy and
        safe and is developed and used in accordance with fundamental rights obligations.
        Diverging national rules may lead to the fragmentation of the internal market
        and may decrease legal certainty for operators that develop, import or use
        AI systems. A consistent and high level of protection throughout the Union
        should therefore be ensured in order to achieve trustworthy AI, while divergences
        hampering the free circulation, innovation, deployment and the uptake of AI
        systems and related products and services within the internal market should
        be prevented by laying down uniform obligations for operators and guaranteeing
        the uniform protection of overriding reasons of public interest and of rights
        of persons throughout the internal market on the basis of Article 114 of the
        Treaty on the Functioning of the European Union (TFEU). To the extent that
        this Regulation contains specific rules on the protection of individuals with
        regard to the processing of personal data concerning restrictions of the use
        of AI systems for remote biometric identification for the purpose of law enforcement,
        of the use of AI systems for risk assessments of natural persons for the purpose
        of law enforcement and of the use of AI systems of biometric categorisation
        for the purpose of law enforcement, it is appropriate to base this Regulation,
        in so far as those specific rules are concerned, on Article 16 TFEU. In light
        of those specific rules and the recourse to Article 16 TFEU, it is appropriate
        to consult the European Data Protection Board.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-4
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 4
      description: AI is a fast evolving family of technologies that contributes to
        a wide array of economic, environmental and societal benefits across the entire
        spectrum of industries and social activities. By improving prediction, optimising
        operations and resource allocation, and personalising digital solutions available
        for individuals and organisations, the use of AI can provide key competitive
        advantages to undertakings and support socially and environmentally beneficial
        outcomes, for example in healthcare, agriculture, food safety, education and
        training, media, sports, culture, infrastructure management, energy, transport
        and logistics, public services, security, justice, resource and energy efficiency,
        environmental monitoring, the conservation and restoration of biodiversity
        and ecosystems and climate change mitigation and adaptation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-5
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 5
      description: At the same time, depending on the circumstances regarding its
        specific application, use, and level of technological development, AI may
        generate risks and cause harm to public interests and fundamental rights that
        are protected by Union law. Such harm might be material or immaterial, including
        physical, psychological, societal or economic harm.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-6
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 6
      description: Given the major impact that AI can have on society and the need
        to build trust, it is vital for AI and its regulatory framework to be developed
        in accordance with Union values as enshrined in Article 2 of the Treaty on
        European Union (TEU), the fundamental rights and freedoms enshrined in the
        Treaties and, pursuant to Article 6 TEU, the Charter. As a pre-requisite,
        AI should be a human-centric technology. It should serve as a tool for people,
        with the ultimate aim of increasing human well-being.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-7
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 7
      description: "In order to ensure a consistent and high level of protection of\
        \ public interests as regards health, safety and fundamental rights, common\
        \ rules for high-risk AI systems should be established. Those rules should\
        \ be consistent with the Charter, non-discriminatory and in line with the\
        \ Union\u2019s international trade commitments. They should also take into\
        \ account the European Declaration on Digital Rights and Principles for the\
        \ Digital Decade and the Ethics guidelines for trustworthy AI of the High-Level\
        \ Expert Group on Artificial Intelligence (AI HLEG)."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-8
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 8
      description: A Union legal framework laying down harmonised rules on AI is therefore
        needed to foster the development, use and uptake of AI in the internal market
        that at the same time meets a high level of protection of public interests,
        such as health and safety and the protection of fundamental rights, including
        democracy, the rule of law and environmental protection as recognised and
        protected by Union law. To achieve that objective, rules regulating the placing
        on the market, the putting into service and the use of certain AI systems
        should be laid down, thus ensuring the smooth functioning of the internal
        market and allowing those systems to benefit from the principle of free movement
        of goods and services. Those rules should be clear and robust in protecting
        fundamental rights, supportive of new innovative solutions, enabling a European
        ecosystem of public and private actors creating AI systems in line with Union
        values and unlocking the potential of the digital transformation across all
        regions of the Union. By laying down those rules as well as measures in support
        of innovation with a particular focus on small and medium enterprises (SMEs),
        including startups, this Regulation supports the objective of promoting the
        European human-centric approach to AI and being a global leader in the development
        of secure, trustworthy and ethical AI  as stated by the European Council,
        and it ensures the protection of ethical principles, as specifically requested
        by the European Parliament.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-9
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 9
      description: "Harmonised rules applicable to the placing on the market, the\
        \ putting into service and the use of high-risk AI systems should be laid\
        \ down consistently with Regulation (EC) No 765/2008 of the European Parliament\
        \ and of the Council, Decision No 768/2008/EC of the European Parliament and\
        \ of the Council and Regulation (EU) 2019/1020 of the European Parliament\
        \ and of the Council (\u2018New Legislative Framework\u2019). The harmonised\
        \ rules laid down in this Regulation should apply across sectors and, in line\
        \ with the New Legislative Framework, should be without prejudice to existing\
        \ Union law, in particular on data protection, consumer protection, fundamental\
        \ rights, employment, and protection of workers, and product safety, to which\
        \ this Regulation is complementary.\nAs a consequence all rights and remedies\
        \ provided for by such Union law to consumers, and other persons on whom AI\
        \ systems may have a negative impact, including as regards the compensation\
        \ of possible damages pursuant to Council Directive 85/374/EEC remain unaffected\
        \ and fully applicable. Furthermore, in the context of employment and protection\
        \ of workers, this Regulation should therefore not affect Union law on social\
        \ policy and national labour law, in accordance with Union law, concerning\
        \ employment and working conditions, including health and safety at work and\
        \ the relationship between employers and workers. This Regulation should also\
        \ not affect the exercise of fundamental rights as recognised in the Member\
        \ States and at Union level, including the right or freedom to strike or to\
        \ take other action covered by the specific industrial relations systems in\
        \ Member States as well as the right to negotiate, to conclude and enforce\
        \ collective agreements or to take collective action in accordance with national\
        \ law.\nThis Regulation should not affect the provisions aiming to improve\
        \ working conditions in platform work laid down in a Directive of the European\
        \ Parliament and of the Council on improving working conditions in platform\
        \ work. Moreover, this Regulation aims to strengthen the effectiveness of\
        \ such existing rights and remedies by establishing specific requirements\
        \ and obligations, including in respect of transparency, technical documentation\
        \ and record-keeping of AI systems. Furthermore, the obligations placed on\
        \ various operators involved in the AI value chain under this Regulation should\
        \ apply without prejudice to national law, in accordance with Union law, having\
        \ the effect of limiting the use of certain AI systems where such law falls\
        \ outside the scope of this Regulation or pursues other legitimate public\
        \ interest objectives than those pursued by this Regulation. For example,\
        \ national labour law and law on the protection of minors, namely persons\
        \ below the age of 18, taking into account the United Nations General Comment\
        \ No 25 (2021) on children\u2019s rights in relation to the digital environment,\
        \ insofar as they are not specific to AI systems and pursue other legitimate\
        \ public interest objectives, should not be affected by this Regulation."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-10
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 10
      description: "The fundamental right to the protection of personal data is safeguarded\
        \ in particular by Regulations (EU) 2016/679 and (EU) 2018/1725 of the European\
        \ Parliament and of the Council and Directive (EU) 2016/680 of the European\
        \ Parliament and of the Council. Directive 2002/58/EC of the European Parliament\
        \ and of the Council additionally protects private life and the confidentiality\
        \ of communications, including by way of providing conditions for any storing\
        \ of personal and non-personal data in and access from terminal equipment.\
        \ Those Union legal acts provide the basis for sustainable and responsible\
        \ data processing, including where data sets include a mix of personal and\
        \ non-personal data. This Regulation does not seek to affect the application\
        \ of existing Union law governing the processing of personal data, including\
        \ the tasks and powers of the independent supervisory authorities competent\
        \ to monitor compliance with those instruments. \nIt also does not affect\
        \ the obligations of providers and deployers of AI systems in their role as\
        \ data controllers or processors stemming from Union or national law on the\
        \ protection of personal data in so far as the design, the development or\
        \ the use of AI systems involves the processing of personal data. It is also\
        \ appropriate to clarify that data subjects continue to enjoy all the rights\
        \ and guarantees awarded to them by such Union law, including the rights related\
        \ to solely automated individual decision-making, including profiling. Harmonised\
        \ rules for the placing on the market, the putting into service and the use\
        \ of AI systems established under this Regulation should facilitate the effective\
        \ implementation and enable the exercise of the data subjects\u2019 rights\
        \ and other remedies guaranteed under Union law on the protection of personal\
        \ data and of other fundamental rights."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-11
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 11
      description: This Regulation should be without prejudice to the provisions regarding
        the liability of intermediary service providers set out in Directive 2000/31/EC
        of the European Parliament and of the Council.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-12
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 12
      description: "The notion of \u2018AI system\u2019 in this Regulation should\
        \ be clearly defined and should be closely aligned with the work of international\
        \ organisations working on AI to ensure legal certainty, facilitate international\
        \ convergence and wide acceptance, while providing the flexibility to accommodate\
        \ the rapid technological developments in this field. Moreover, it should\
        \ be based on key characteristics of AI systems that distinguish it from simpler\
        \ traditional software systems or programming approaches and should not cover\
        \ systems that are based on the rules defined solely by natural persons to\
        \ automatically execute operations. A key characteristic of AI systems is\
        \ their capability to infer. This capability to infer refers to the process\
        \ of obtaining the outputs, such as predictions, content, recommendations,\
        \ or decisions, which can influence physical and virtual environments, and\
        \ to a capability of AI systems to derive models or algorithms from inputs\
        \ or data. The techniques that enable inference while building an AI system\
        \ include machine learning approaches that learn from data how to achieve\
        \ certain objectives, and logic- and knowledge-based approaches that infer\
        \ from encoded knowledge or symbolic representation of the task to be solved.\
        \ The capacity of an AI system to infer transcends basic data processing,\
        \ enables learning, reasoning or modelling. The term \u2018machine-based\u2019\
        \ refers to the fact that AI systems run on machines.\nThe reference to explicit\
        \ or implicit objectives underscores that AI systems can operate according\
        \ to explicit defined objectives or to implicit objectives. The objectives\
        \ of the AI system may be different from the intended purpose of the AI system\
        \ in a specific context. For the purposes of this Regulation, environments\
        \ should be understood to be the contexts in which the AI systems operate,\
        \ whereas outputs generated by the AI system reflect different functions performed\
        \ by AI systems and include predictions, content, recommendations or decisions.\
        \ AI systems are designed to operate with varying levels of autonomy, meaning\
        \ that they have some degree of independence of actions from human involvement\
        \ and of capabilities to operate without human intervention. The adaptiveness\
        \ that an AI system could exhibit after deployment, refers to self-learning\
        \ capabilities, allowing the system to change while in use. AI systems can\
        \ be used on a stand-alone basis or as a component of a product, irrespective\
        \ of whether the system is physically integrated into the product (embedded)\
        \ or serve the functionality of the product without being integrated therein\
        \ (non-embedded)."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-13
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 13
      description: "The notion of \u2018deployer\u2019 referred to in this Regulation\
        \ should be interpreted as any natural or legal person, including a public\
        \ authority, agency or other body, using an AI system under its authority,\
        \ except where the AI system is used in the course of a personal non-professional\
        \ activity. Depending on the type of AI system, the use of the system may\
        \ affect persons other than the deployer."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-14
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 14
      description: "The notion of \u2018biometric data\u2019 used in this Regulation\
        \ should be interpreted in light of the notion of biometric data as defined\
        \ in Article 4, point (14) of Regulation (EU) 2016/679, Article 3, point (18)\
        \ of Regulation (EU) 2018/1725 and Article 3, point (13) of Directive (EU)\
        \ 2016/680. Biometric data can allow for the authentication, identification\
        \ or categorisation of natural persons and for the recognition of emotions\
        \ of natural persons."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-15
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 15
      description: "The notion of \u2018biometric identification\u2019 referred to\
        \ in this Regulation should be defined as the automated recognition of physical,\
        \ physiological and behavioural human features such as the face, eye movement,\
        \ body shape, voice, prosody, gait, posture, heart rate, blood pressure, odour,\
        \ keystrokes characteristics, for the purpose of establishing an individual\u2019\
        s identity by comparing biometric data of that individual to stored biometric\
        \ data of individuals in a reference database, irrespective of whether the\
        \ individual has given its consent or not. This excludes AI systems intended\
        \ to be used for biometric verification, which includes authentication, whose\
        \ sole purpose is to confirm that a specific natural person is the person\
        \ he or she claims to be and to confirm the identity of a natural person for\
        \ the sole purpose of having access to a service, unlocking a device or having\
        \ security access to premises."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-16
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 16
      description: "The notion of \u2018biometric categorisation\u2019 referred to\
        \ in this Regulation should be defined as assigning natural persons to specific\
        \ categories on the basis of their biometric data. Such specific categories\
        \ can relate to aspects such as sex, age, hair colour, eye colour, tattoos,\
        \ behavioural or personality traits, language, religion, membership of a national\
        \ minority, sexual or political orientation. This does not include biometric\
        \ categorisation systems that are a purely ancillary feature intrinsically\
        \ linked to another commercial service meaning that the feature cannot, for\
        \ objective technical reasons, be used without the principal service and the\
        \ integration of that feature or functionality is not a means to circumvent\
        \ the applicability of the rules of this Regulation. For example, filters\
        \ categorising facial or body features used on online marketplaces could constitute\
        \ such an ancillary feature as they can be used only in relation to the principal\
        \ service which consists in selling a product by allowing the consumer to\
        \ preview the display of the product on him or herself and help the consumer\
        \ to make a purchase decision. Filters used on online social network services\
        \ which categorise facial or body features to allow users to add or modify\
        \ pictures or videos could also be considered to be ancillary feature as such\
        \ filter cannot be used without the principal service of the social network\
        \ services consisting in the sharing of content online."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-17
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 17
      description: "The notion of \u2018remote biometric identification system\u2019\
        \ referred to in this Regulation should be defined functionally, as an AI\
        \ system intended for the identification of natural persons without their\
        \ active involvement, typically at a distance, through the comparison of a\
        \ person\u2019s biometric data with the biometric data contained in a reference\
        \ database, irrespectively of the particular technology, processes or types\
        \ of biometric data used. Such remote biometric identification systems are\
        \ typically used to perceive multiple persons or their behaviour simultaneously\
        \ in order to facilitate significantly the identification of natural persons\
        \ without their active involvement. This excludes AI systems intended to be\
        \ used for biometric verification, which includes authentication, the sole\
        \ purpose of which is to confirm that a specific natural person is the person\
        \ he or she claims to be and to confirm the identity of a natural person for\
        \ the sole purpose of having access to a service, unlocking a device or having\
        \ security access to premises. That exclusion is justified by the fact that\
        \ such systems are likely to have a minor impact on fundamental rights of\
        \ natural persons compared to the remote biometric identification systems\
        \ which may be used for the processing of the biometric data of a large number\
        \ of persons without their active involvement. In the case of \u2018real-time\u2019\
        \ systems, the capturing of the biometric data, the comparison and the identification\
        \ occur all instantaneously, near-instantaneously or in any event without\
        \ a significant delay. In this regard, there should be no scope for circumventing\
        \ the rules of this Regulation on the \u2018real- time\u2019 use of the AI\
        \ systems concerned by providing for minor delays. \u2018Real-time\u2019 systems\
        \ involve the use of \u2018live\u2019 or \u2018near-live\u2019 material, such\
        \ as video footage, generated by a camera or other device with similar functionality.\
        \ In the case of \u2018post\u2019 systems, in contrast, the biometric data\
        \ have already been captured and the comparison and identification occur only\
        \ after a significant delay. This involves material, such as pictures or video\
        \ footage generated by closed circuit television cameras or private devices,\
        \ which has been generated before the use of the system in respect of the\
        \ natural persons concerned."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-18
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 18
      description: "The notion of \u2018emotion recognition system\u2019 referred\
        \ to in this Regulation should be defined as an AI system for the purpose\
        \ of identifying or inferring emotions or intentions of natural persons on\
        \ the basis of their biometric data. The notion refers to emotions or intentions\
        \ such as happiness, sadness, anger, surprise, disgust, embarrassment, excitement,\
        \ shame, contempt, satisfaction and amusement. It does not include physical\
        \ states, such as pain or fatigue; this refers for example to systems used\
        \ in detecting the state of fatigue of professional pilots or drivers for\
        \ the purpose of preventing accidents. This does also not include the mere\
        \ detection of readily apparent expressions, gestures or movements, unless\
        \ they are used for identifying or inferring emotions. Those expressions can\
        \ be basic facial expressions, such as a frown or a smile, or gestures such\
        \ as the movement of hands, arms or head, or characteristics of a person\u2019\
        s voice, such as a raised voice or whispering."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-19
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 19
      description: "For the purposes of this Regulation the notion of \u2018publicly\
        \ accessible space\u2019 should be understood as referring to any physical\
        \ place that is accessible to an undetermined number of natural persons, and\
        \ irrespective of whether the place in question is privately or publicly owned,\
        \ irrespective of the activity for which the place may be used, such as commerce\
        \ (for instance, shops, restaurants, caf\xE9s), services (for instance, banks,\
        \ professional activities, hospitality), sport (for instance, swimming pools,\
        \ gyms, stadiums), transport (for instance, bus, metro and railway stations,\
        \ airports, means of transport ), entertainment (for instance, cinemas, theatres,\
        \ museums, concert and conference halls), or leisure or otherwise (for instance,\
        \ public roads and squares, parks, forests, playgrounds). A place should be\
        \ classified as publicly accessible also if, regardless of potential capacity\
        \ or security restrictions, access is subject to certain predetermined conditions,\
        \ which can be fulfilled by an undetermined number of persons, such as purchase\
        \ of a ticket or title of transport, prior registration or having a certain\
        \ age. In contrast, a place should not be considered to be publicly accessible\
        \ if access is limited to specific and defined natural persons through either\
        \ Union or national law directly related to public safety or security or through\
        \ the clear manifestation of will by the person having the relevant authority\
        \ on the place. The factual possibility of access alone (such as an unlocked\
        \ door or an open gate in a fence) does not imply that the place is publicly\
        \ accessible in the presence of indications or circumstances suggesting the\
        \ contrary (such as. signs prohibiting or restricting access). Company and\
        \ factory premises, as well as offices and workplaces that are intended to\
        \ be accessed only by relevant employees and service providers, are places\
        \ that are not publicly accessible. Publicly accessible spaces should not\
        \ include prisons or border control. Some other areas may be composed of both\
        \ not publicly accessible and publicly accessible areas, such as the hallway\
        \ of a private residential building necessary to access a doctor's office\
        \ or an airport. Online spaces are not covered either, as they are not physical\
        \ spaces. Whether a given space is accessible to the public should however\
        \ be determined on a case- by-case basis, having regard to the specificities\
        \ of the individual situation at hand."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-20
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 20
      description: "In order to obtain the greatest benefits from AI systems while\
        \ protecting fundamental rights, health and safety and to enable democratic\
        \ control, AI literacy should equip providers, deployers and affected persons\
        \ with the necessary notions to make informed decisions regarding AI systems.\
        \ Those notions may vary with regard to the relevant context and can include\
        \ understanding the correct application of technical elements during the AI\
        \ system\u2019s development phase, the measures to be applied during its use,\
        \ the suitable ways in which to interpret the AI system\u2019s output, and,\
        \ in the case of affected persons, the knowledge necessary to understand how\
        \ decisions taken with the assistance of AI will have an impact on them. In\
        \ the context of the application this Regulation, AI literacy should provide\
        \ all relevant actors in the AI value chain with the insights required to\
        \ ensure the appropriate compliance and its correct enforcement. Furthermore,\
        \ the wide implementation of AI literacy measures and the introduction of\
        \ appropriate follow-up actions could contribute to improving working conditions\
        \ and ultimately sustain the consolidation, and innovation path of trustworthy\
        \ AI in the Union. The European Artificial Intelligence Board (the \u2018\
        Board\u2019) should support the Commission, to promote AI literacy tools,\
        \ public awareness and understanding of the benefits, risks, safeguards, rights\
        \ and obligations in relation to the use of AI systems. In cooperation with\
        \ the relevant stakeholders, the Commission and the Member States should facilitate\
        \ the drawing up of voluntary codes of conduct to advance AI literacy among\
        \ persons dealing with the development, operation and use of AI."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-21
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 21
      description: In order to ensure a level playing field and an effective protection
        of rights and freedoms of individuals across the Union, the rules established
        by this Regulation should apply to providers of AI systems in a non-discriminatory
        manner, irrespective of whether they are established within the Union or in
        a third country, and to deployers of AI systems established within the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-22
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 22
      description: 'In light of their digital nature, certain AI systems should fall
        within the scope of this Regulation even when they are not placed on the market,
        put into service, or used in the Union. This is the case, for example, where
        an operator established in the Union contracts certain services to an operator
        established in a third country in relation to an activity to be performed
        by an AI system that would qualify as high-risk  . In those circumstances,
        the AI system used in a third country by the operator could process data lawfully
        collected in and transferred from the Union, and provide to the contracting
        operator in the Union the output of that AI system resulting from that processing,
        without that AI system being placed on the market, put into service or used
        in the Union. To prevent the circumvention of this Regulation and to ensure
        an effective protection of natural persons located in the Union, this Regulation
        should also apply to providers and deployers of AI systems that are established
        in a third country, to the extent the output produced by those systems is
        intended to be used in the Union.

        Nonetheless, to take into account existing arrangements and special needs
        for future cooperation with foreign partners with whom information and evidence
        is exchanged, this Regulation should not apply to public authorities of a
        third country and international organisations when acting in the framework
        of cooperation or international agreements concluded at Union or national
        level for law enforcement and judicial cooperation with the Union or the Member
        States, provided that the relevant third country or international organisations
        provides adequate safeguards with respect to the protection of fundamental
        rights and freedoms of individuals. Where relevant, this may cover activities
        of entities entrusted by the third countries to carry out specific tasks in
        support of such law enforcement and judicial cooperation. Such framework for
        cooperation or agreements have been established bilaterally between Member
        States and third countries or between the European Union, Europol and other
        Union agencies and third countries and international organisations. The authorities
        competent for supervision of the law enforcement and judicial authorities
        under this Regulation should assess whether those frameworks for cooperation
        or international agreements include adequate safeguards with respect to the
        protection of fundamental rights and freedoms of individuals. Recipient Member
        States authorities and Union institutions, bodies, offices and agencies making
        use of such outputs in the Union remain accountable to ensure their use complies
        with Union law. When those international agreements are revised or new ones
        are concluded in the future, the contracting parties should undertake the
        utmost effort to align those agreements with the requirements of this Regulation.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-23
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 23
      description: This Regulation should also apply to Union institutions, bodies,
        offices and agencies when acting as a provider or deployer of an AI system
    - urn: urn:intuitem:risk:req_node:ai-act:recital-24
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 24
      description: "If and insofar AI systems are placed on the market, put into service,\
        \ or used with or without modification of such systems for military, defence\
        \ or national security purposes, those should be excluded from the scope of\
        \ this Regulation regardless of which type of entity is carrying out those\
        \ activities, such as whether it is a public or private entity. As regards\
        \ military and defence purposes, such exclusion is justified both by Article\
        \ 4(2) TEU and by the specificities of the Member States\u2019 and the common\
        \ Union defence policy covered by Chapter 2 of Title V TEU that are subject\
        \ to public international law, which is therefore the more appropriate legal\
        \ framework for the regulation of AI systems in the context of the use of\
        \ lethal force and other AI systems in the context of military and defence\
        \ activities. As regards national security purposes, the exclusion is justified\
        \ both by the fact that national security remains the sole responsibility\
        \ of Member States in accordance with Article 4(2) TEU and by the specific\
        \ nature and operational needs of national security activities and specific\
        \ national rules applicable to those activities. Nonetheless, if an AI system\
        \ developed, placed on the market, put into service or used for military,\
        \ defence or national security purposes is used outside those temporarily\
        \ or permanently for other purposes, for example, civilian or humanitarian\
        \ purposes, law enforcement or public security purposes, such a system would\
        \ fall within the scope of this Regulation.\nIn that case, the entity using\
        \ the system for other than military, defence or national security purposes\
        \ should ensure compliance of the system with this Regulation, unless the\
        \ system is already compliant with this Regulation. AI systems placed on the\
        \ market or put into service for an excluded purpose, namely military, defence\
        \ or national security, and one or more non-excluded purposes, such as civilian\
        \ purposes or law enforcement, fall within the scope of this Regulation and\
        \ providers of those systems should ensure compliance with this Regulation.\
        \ In those cases, the fact that an AI system may fall within the scope of\
        \ this Regulation should not affect the possibility of entities carrying out\
        \ national security, defence and military activities, regardless of the type\
        \ of entity carrying out those activities, to use AI systems for national\
        \ security, military and defence purposes, the use of which is excluded from\
        \ the scope of this Regulation. An AI system placed on the market for civilian\
        \ or law enforcement purposes which is used with or without modification for\
        \ military, defence or national security purposes should not fall within the\
        \ scope of this Regulation, regardless of the type of entity carrying out\
        \ those activities."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-25
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 25
      description: This Regulation should support innovation, respect freedom of science,
        and should not undermine research and development activity. It is therefore
        necessary to exclude from its scope AI systems and models specifically developed
        and put into service for the sole purpose of scientific research and development.
        Moreover, it is necessary to ensure that this Regulation does not otherwise
        affect scientific research and development activity on AI systems or models
        prior to being placed on the market or put into service. As regards product
        oriented research, testing and development activity regarding AI systems or
        models, the provisions of this Regulation should also not apply prior to those
        systems and models being put into service or placed on the market. That exclusion
        is without prejudice to the obligation to comply with this Regulation where
        an AI system falling into the scope of this Regulation is placed on the market
        or put into service as a result of such research and development activity
        and to the application of provisions on regulatory sandboxes and testing in
        real world conditions. Furthermore, without prejudice to exclusion regarding
        AI systems specifically developed and put into service for the sole purpose
        of scientific research and development, any other AI system that may be used
        for the conduct of any research and development activity should remain subject
        to the provisions of this Regulation. In any event, any research and development
        activity should be carried out in accordance with recognised ethical and professional
        standards for scientific research and should be conducted in accordance with
        applicable Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-26
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 26
      description: In order to introduce a proportionate and effective set of binding
        rules for AI systems, a clearly defined risk-based approach should be followed.
        That approach should tailor the type and content of such rules to the intensity
        and scope of the risks that AI systems can generate. It is therefore necessary
        to prohibit certain unacceptable AI practices, to lay down requirements for
        high-risk AI systems and obligations for the relevant operators, and to lay
        down transparency obligations for certain AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-27
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 27
      description: While the risk-based approach is the basis for a proportionate
        and effective set of binding rules, it is important to recall the 2019 Ethics
        guidelines for trustworthy AI developed by the independent AI HLEG appointed
        by the Commission. In those guidelines, the AI HLEG developed seven non-binding
        ethical principles for AI which are intended to help ensure that AI is trustworthy
        and ethically sound. The seven principles include human agency and oversight;
        technical robustness and safety; privacy and data governance; transparency;
        diversity, non-discrimination and fairness; societal and environmental well-being
        and accountability. Without prejudice to the legally binding requirements
        of this Regulation and any other applicable Union law, those guidelines contribute
        to the design of a coherent, trustworthy and human-centric AI, in line with
        the Charter and with the values on which the Union is founded. According to
        the guidelines of the AI HLEG, human agency and oversight means that AI systems
        are developed and used as a tool that serves people, respects human dignity
        and personal autonomy, and that is functioning in a way that can be appropriately
        controlled and overseen by humans. Technical robustness and safety means that
        AI systems are developed and used in a way that allows robustness in the case
        of problems and resilience against attempts to alter the use or performance
        of the AI system so as to allow unlawful use by third parties, and minimise
        unintended harm. Privacy and data governance means that AI systems are developed
        and used in accordance with privacy and data protection rules, while processing
        data that meets high standards in terms of quality and integrity. Transparency
        means that AI systems are developed and used in a way that allows appropriate
        traceability and explainability, while making humans aware that they communicate
        or interact with an AI system, as well as duly informing deployers of the
        capabilities and limitations of that AI system and affected persons about
        their rights. Diversity, non-discrimination and fairness means that AI systems
        are developed and used in a way that includes diverse actors and promotes
        equal access, gender equality and cultural diversity, while avoiding discriminatory
        impacts and unfair biases that are prohibited by Union or national law. Social
        and environmental well-being means that AI systems are developed and used
        in a sustainable and environmentally friendly manner as well as in a way to
        benefit all human beings, while monitoring and assessing the long- term impacts
        on the individual, society and democracy. The application of those principles
        should be translated, when possible, in the design and use of AI models. They
        should in any case serve as a basis for the drafting of codes of conduct under
        this Regulation. All stakeholders, including industry, academia, civil society
        and standardisation organisations, are encouraged to take into account as
        appropriate the ethical principles for the development of voluntary best practices
        and standards.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-28
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 28
      description: Aside from the many beneficial uses of AI, that technology can
        also be misused and provide novel and powerful tools for manipulative, exploitative
        and social control practices. Such practices are particularly harmful and
        abusive and should be prohibited because they contradict Union values of respect
        for human dignity, freedom, equality, democracy and the rule of law and fundamental
        rights enshrined in the Charter, including the right to non-discrimination,
        to data protection and to privacy and the rights of the child.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-29
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 29
      description: "AI-enabled manipulative techniques can be used to persuade persons\
        \ to engage in unwanted behaviours, or to deceive them by nudging them into\
        \ decisions in a way that subverts and impairs their autonomy, decision-making\
        \ and free choices. The placing on the market, the putting into service or\
        \ the use of certain AI systems with the objective to or the effect of materially\
        \ distorting human behaviour, whereby significant harms, in particular having\
        \ sufficiently important adverse impacts on physical, psychological health\
        \ or financial interests are likely to occur, are particularly dangerous and\
        \ should therefore be forbidden. Such AI systems deploy subliminal components\
        \ such as audio, image, video stimuli that persons cannot perceive as those\
        \ stimuli are beyond human perception or other manipulative or deceptive techniques\
        \ that subvert or impair person\u2019s autonomy, decision-making or free choice\
        \ in ways that people are not consciously aware or, where they are aware,\
        \ they are still deceived or are not able to control or resist. This could\
        \ be facilitated, for example, by machine-brain interfaces or virtual reality\
        \ as they allow for a higher degree of control of what stimuli are presented\
        \ to persons, insofar as they may materially distort their behaviour in a\
        \ significantly harmful manner. In addition, AI systems may also otherwise\
        \ exploit the vulnerabilities of a person or a specific group of persons due\
        \ to their age, disability within the meaning of Directive (EU) 2019/882 of\
        \ the European Parliament and of the Council, or a specific social or economic\
        \ situation that is likely to make those persons more vulnerable to exploitation\
        \ such as persons living in extreme poverty, ethnic or religious minorities.\n\
        Such AI systems can be placed on the market, put into service or used with\
        \ the objective to or the effect of materially distorting the behaviour of\
        \ a person and in a manner that causes or is reasonably likely to cause significant\
        \ harm to that or another person or groups of persons, including harms that\
        \ may be accumulated over time and should therefore be prohibited. It may\
        \ not be possible to assume that there is an intention to distort behaviour\
        \ where the distortion results from factors external to the AI system which\
        \ are outside the control of the provider or the deployer, namely factors\
        \ that may not be reasonably foreseeable and therefore not possible for the\
        \ provider or the deployer of the AI system to mitigate. In any case, it is\
        \ not necessary for the provider or the deployer to have the intention to\
        \ cause significant harm, provided that such harm results from the manipulative\
        \ or exploitative AI-enabled practices. The prohibitions for such AI practices\
        \ are complementary to the provisions contained in Directive 2005/29/EC of\
        \ the European Parliament and of the Council, in particular unfair commercial\
        \ practices leading to economic or financial harms to consumers are prohibited\
        \ under all circumstances, irrespective of whether they are put in place through\
        \ AI systems or otherwise. The prohibitions of manipulative and exploitative\
        \ practices in this Regulation should not affect lawful practices in the context\
        \ of medical treatment such as psychological treatment of a mental disease\
        \ or physical rehabilitation, when those practices are carried out in accordance\
        \ with the applicable law and medical standards, for example explicit consent\
        \ of the individuals or their legal representatives. In addition, common and\
        \ legitimate commercial practices, for example in the field of advertising,\
        \ that comply with the applicable law should not, in themselves, be regarded\
        \ as constituting harmful manipulative AI practices."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-30
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 30
      description: "Biometric categorisation systems that are based on natural persons\u2019\
        \ biometric data, such as an individual person\u2019s face or fingerprint,\
        \ to deduce or infer an individuals\u2019 political opinions, trade union\
        \ membership, religious or philosophical beliefs, race, sex life or sexual\
        \ orientation should be prohibited. That prohibition should not cover the\
        \ lawful labelling, filtering or categorisation of biometric data sets acquired\
        \ in line with Union or national law according to biometric data, such as\
        \ the sorting of images according to hair colour or eye colour, which can\
        \ for example be used in the area of law enforcement."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-31
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 31
      description: AI systems providing social scoring of natural persons  by public
        or private actors may lead to discriminatory outcomes and the exclusion of
        certain groups. They may violate the right to dignity and non-discrimination
        and the values of equality and justice. Such AI systems evaluate or classify
        natural persons or groups thereof on the basis of multiple data points related
        to their social behaviour in multiple contexts or known, inferred or predicted
        personal or personality characteristics over certain periods of time. The
        social score obtained from such AI systems may lead to the detrimental or
        unfavourable treatment of natural persons or whole groups thereof in social
        contexts, which are unrelated to the context in which the data was originally
        generated or collected or to a detrimental treatment that is disproportionate
        or unjustified to the gravity of their social behaviour. AI systems entailing
        such unacceptable scoring practices and leading to such detrimental or unfavourable
        outcomes should be therefore prohibited. That prohibition should not affect
        lawful evaluation practices of natural persons that are carried out for a
        specific purpose in accordance with Union and national law.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-32
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 32
      description: "The use of AI systems for \u2018real-time\u2019 remote biometric\
        \ identification of natural persons in publicly accessible spaces for the\
        \ purpose of law enforcement is particularly intrusive to the rights and freedoms\
        \ of the concerned persons, to the extent that it may affect the private life\
        \ of a large part of the population, evoke a feeling of constant surveillance\
        \ and indirectly dissuade the exercise of the freedom of assembly and other\
        \ fundamental rights. Technical inaccuracies of AI systems intended for the\
        \ remote biometric identification of natural persons can lead to biased results\
        \ and entail discriminatory effects. Such possible biased results and discriminatory\
        \ effects are particularly relevant with regard to age, ethnicity, race, sex\
        \ or disabilities. In addition, the immediacy of the impact and the limited\
        \ opportunities for further checks or corrections in relation to the use of\
        \ such systems operating in real-time carry heightened risks for the rights\
        \ and freedoms of the persons that are concerned by law enforcement activities."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-33
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 33
      description: "The use of those systems for the purpose of law enforcement should\
        \ therefore be prohibited, except in exhaustively listed and narrowly defined\
        \ situations, where the use is strictly necessary to achieve a substantial\
        \ public interest, the importance of which outweighs the risks. Those situations\
        \ involve the search for certain victims of crime including missing people;\
        \ certain threats to the life or to the physical safety of natural persons\
        \ or of a terrorist attack; and the localisation or identification of perpetrators\
        \ or suspects of the criminal offences listed in an annex to this Regulation,\
        \ where those criminal offences are punishable by a custodial sentence or\
        \ a detention order for a maximum period of at least four years in the Member\
        \ State concerned in accordance with the law of that Member State. Such a\
        \ threshold for the custodial sentence or detention order in accordance with\
        \ national law contributes to ensuring that the offence should be serious\
        \ enough to potentially justify the use of \u2018real-time\u2019 remote biometric\
        \ identification systems.\nMoreover, those criminal offences are based on\
        \ the 32 criminal offences listed in the Council Framework Decision 2002/584/JHA,\
        \ taking into account that some of those offences are, in practice, likely\
        \ to be more relevant than others, in that the recourse to \u2018real- time\u2019\
        \ remote biometric identification is, foreseeably, necessary and proportionate\
        \ to highly varying degrees for the practical pursuit of the localisation\
        \ or identification of a perpetrator or suspect of the different criminal\
        \ offences listed and having regard to the likely differences in the seriousness,\
        \ probability and scale of the harm or possible negative consequences. An\
        \ imminent threat to life or the physical safety of natural persons could\
        \ also result from a serious disruption of critical infrastructure, as defined\
        \ in Article 2, point (4) of Directive (EU) 2022/2557 of the European Parliament\
        \ and of the Council, where the disruption or destruction of such critical\
        \ infrastructure would result in an imminent threat to life or the physical\
        \ safety of a person, including through serious harm to the provision of basic\
        \ supplies to the population or to the exercise of the core function of the\
        \ State. In addition, this Regulation should preserve the ability for law\
        \ enforcement, border control, immigration or asylum authorities to carry\
        \ out identity checks in the presence of the person that is concerned in accordance\
        \ with the conditions set out in Union and national law for such checks. In\
        \ particular, law enforcement, border control, immigration or asylum authorities\
        \ should be able to use information systems, in accordance with Union or national\
        \ law, to identify persons who, during an identity check, either refuse to\
        \ be identified or are unable to state or prove their identity, without being\
        \ required by this Regulation to obtain prior authorisation. This could be,\
        \ for example, a person involved in a crime, being unwilling, or unable due\
        \ to an accident or a medical condition, to disclose their identity to law\
        \ enforcement authorities."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-34
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 34
      description: "In order to ensure that those systems are used in a responsible\
        \ and proportionate manner, it is also important to establish that, in each\
        \ of those exhaustively listed and narrowly defined situations, certain elements\
        \ should be taken into account, in particular as regards the nature of the\
        \ situation giving rise to the request and the consequences of the use for\
        \ the rights and freedoms of all persons concerned and the safeguards and\
        \ conditions provided for with the use. In addition, the use of \u2018real-time\u2019\
        \ remote biometric identification systems in publicly accessible spaces for\
        \ the purpose of law enforcement should be deployed only to confirm the specifically\
        \ targeted individual\u2019s identity and should be limited to what is strictly\
        \ necessary concerning the period of time as well as geographic and personal\
        \ scope, having regard in particular to the evidence or indications regarding\
        \ the threats, the victims or perpetrator. The use of the real-time remote\
        \ biometric identification system in publicly accessible spaces should be\
        \ authorised only if the relevant law enforcement authority has completed\
        \ a fundamental rights impact assessment and, unless provided otherwise in\
        \ this Regulation, has registered the system in the database as set out in\
        \ this Regulation. The reference database of persons should be appropriate\
        \ for each use case in each of the situations mentioned above."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-35
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 35
      description: "Each use of a \u2018real-time\u2019 remote biometric identification\
        \ system in publicly accessible spaces for the purpose of law enforcement\
        \ should be subject to an express and specific authorisation by a judicial\
        \ authority or by an independent administrative authority whose decision is\
        \ binding of a Member State. Such authorisation should, in principle, be obtained\
        \ prior to the use of the AI system with a view to identifying a person or\
        \ persons. Exceptions to that rule should be allowed in duly justified situations\
        \ on grounds of urgency, namely, in situations where the need to use the systems\
        \ concerned is such as to make it effectively and objectively impossible to\
        \ obtain an authorisation before commencing the use of the AI system. In such\
        \ situations of urgency, the use of the AI system should be restricted to\
        \ the absolute minimum necessary and should be subject to appropriate safeguards\
        \ and conditions, as determined in national law and specified in the context\
        \ of each individual urgent use case by the law enforcement authority itself.\
        \ In addition, the law enforcement authority should in such situations request\
        \ such authorisation  while providing the reasons for not having been able\
        \ to request it earlier, without undue delay and, at the latest within 24\
        \ hours. If such an authorisation is rejected, the use of real-time biometric\
        \ identification systems linked to that authorisation should cease with immediate\
        \ effect and all the data related to such use should be discarded and deleted.\
        \ Such data includes input data directly acquired by an AI system in the course\
        \ of the use of such system as well as the results and outputs of the use\
        \ linked to that authorisation. It should not include input that is legally\
        \ acquired in accordance with another Union or national law. In any case,\
        \ no decision producing an adverse legal effect on a person should be taken\
        \ based solely on the output of the remote biometric identification system."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-36
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 36
      description: In order to carry out their tasks in accordance with the requirements
        set out in this Regulation as well as in national rules, the relevant market
        surveillance authority and the national data protection authority should be
        notified of each use of the real-time biometric identification system. National
        market surveillance authorities and the national data protection authorities
        that have been notified should submit to the Commission an annual report on
        the use of real-time biometric identification systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-37
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 37
      description: Furthermore, it is appropriate to provide, within the exhaustive
        framework set by this Regulation that such use in the territory of a Member
        State in accordance with this Regulation should only be possible where and
        in as far as the Member State concerned has decided to expressly provide for
        the possibility to authorise such use in its detailed rules of national law.
        Consequently, Member States remain free under this Regulation not to provide
        for such a possibility at all or to only provide for such a possibility in
        respect of some of the objectives capable of justifying authorised use identified
        in this Regulation. Such national rules should be notified to the Commission
        within 30 days of their adoption.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-38
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 38
      description: The use of AI systems for real-time remote biometric identification
        of natural persons in publicly accessible spaces for the purpose of law enforcement
        necessarily involves the processing of biometric data. The rules of this Regulation
        that prohibit, subject to certain exceptions, such use, which are based on
        Article 16 TFEU, should apply as lex specialis in respect of the rules on
        the processing of biometric data contained in Article 10 of Directive (EU)
        2016/680, thus regulating such use and the processing of biometric data involved
        in an exhaustive manner. Therefore, such use and processing should be possible
        only in as far as it is compatible with the framework set by this Regulation,
        without there being scope, outside that framework, for the competent authorities,
        where they act for purpose of law enforcement, to use such systems and process
        such data in connection thereto on the grounds listed in Article 10 of Directive
        (EU) 2016/680. In that context, this Regulation is not intended to provide
        the legal basis for the processing of personal data under Article 8 of Directive
        (EU) 2016/680. However, the use of real-time remote biometric identification
        systems in publicly accessible spaces for purposes other than law enforcement,
        including by competent authorities, should not be covered by the specific
        framework regarding such use for the purpose of law enforcement set by this
        Regulation. Such use for purposes other than law enforcement should therefore
        not be subject to the requirement of an authorisation under this Regulation
        and the applicable detailed rules of national law that may give effect to
        that authorisation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-39
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 39
      description: "Any processing of biometric data and other personal data involved\
        \ in the use of AI systems for biometric identification, other than in connection\
        \ to the use of real-time remote biometric identification systems in publicly\
        \ accessible spaces for the purpose of law enforcement as regulated by this\
        \ Regulation, should continue to comply with all requirements resulting from\
        \ Article 10 of Directive (EU) 2016/680. For purposes other than law enforcement,\
        \ \u258C Article 9(1) of Regulation (EU) 2016/679 and Article 10(1) of Regulation\
        \ (EU) 2018/1725 prohibit the processing of biometric data subject to limited\
        \ exceptions as provided in those Articles. In the application of Article\
        \ 9(1) of Regulation (EU) 2016/679, the use of remote biometric identification\
        \ for purposes other than law enforcement has already been subject to prohibition\
        \ decisions by national data protection authorities."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-40
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 40
      description: In accordance with Article 6a of Protocol No 21 on the position
        of the United Kingdom and Ireland in respect of the area of freedom, security
        and justice, as annexed to the TEU and to the TFEU, Ireland is not bound by
        the rules laid down in Article 5(1), point (c) to the extent it applies to
        the use of biometric categorisation systems for activities in the field of
        police cooperation and judicial cooperation in criminal matters, Article 5(1),
        points (e) and (f) to the extent they apply to the use of AI systems covered
        by that provision, Article 5(3) to (8) and Article 26(10) of this Regulation
        adopted on the basis of Article 16 of the TFEU which relate to the processing
        of personal data by the Member States when carrying out activities falling
        within the scope of Chapter 4 or Chapter 5 of Title V of Part Three of the
        TFEU, where Ireland is not bound by the rules governing the forms of judicial
        cooperation in criminal matters or police cooperation which require compliance
        with the provisions laid down on the basis of Article 16 TFEU.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-41
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 41
      description: In accordance with Articles 2 and 2a of Protocol No 22 on the position
        of Denmark, annexed to the TEU and to the TFEU, Denmark is not bound by rules
        laid down in Article 5(1), point (c) to the extent it applies to the use of
        biometric categorisation systems for activities in the field of police cooperation
        and judicial cooperation in criminal matters, Article 5(1), point (e), point
        (f) to the extent it applies to the use of AI systems covered by that provision,
        Article 5(3) to (8) and Article 26(10) of this Regulation adopted on the basis
        of Article 16 of the TFEU, or subject to their application, which relate to
        the processing of personal data by the Member States when carrying out activities
        falling within the scope of Chapter 4 or Chapter 5 of Title V of Part Three
        of the TFEU.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-42
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 42
      description: In line with the presumption of innocence, natural persons in the
        Union should always be judged on their actual behaviour. Natural persons should
        never be judged on AI- predicted behaviour based solely on their profiling,
        personality traits or characteristics, such as nationality, place of birth,
        place of residence, number of children, level of debt or type of car, without
        a reasonable suspicion of that person being involved in a criminal activity
        based on objective verifiable facts and without human assessment thereof.
        Therefore, risk assessments carried out with regard to natural persons in
        order to assess the risk of their offending or to predict the occurrence of
        an actual or potential criminal offence based solely on profiling them or
        on assessing their personality traits and characteristics should be prohibited.
        In any case, that prohibition does not refer to or touch upon risk analytics
        that are not based on the profiling of individuals or on the personality traits
        and characteristics of individuals, such as AI systems using risk analytics
        to assess the risk of financial fraud by undertakings on the basis of suspicious
        transactions or risk analytic tools to predict the likelihood of the localisation
        of narcotics or illicit goods by customs authorities, for example on the basis
        of known trafficking routes.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-43
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 43
      description: The placing on the market, the putting into service for this specific
        purpose, or use of AI systems that create or expand facial recognition databases
        through the untargeted scraping of facial images from the internet or CCTV
        footage, should be prohibited because that practice adds to the feeling of
        mass surveillance and can lead to gross violations of fundamental rights,
        including the right to privacy.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-44
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 44
      description: There are serious concerns about the scientific basis of AI systems
        aiming to identify or infer emotions, particularly as expression of emotions
        vary considerably across cultures and situations, and even within a single
        individual. Among the key shortcomings of such systems are the limited reliability,
        the lack of specificity and the limited generalisability. Therefore, AI systems
        identifying or inferring emotions or intentions of natural persons on the
        basis of their biometric data may lead to discriminatory outcomes and can
        be intrusive to the rights and freedoms of the concerned persons. Considering
        the imbalance of power in the context of work or education, combined with
        the intrusive nature of these systems, such systems could lead to detrimental
        or unfavourable treatment of certain natural persons or whole groups thereof.
        Therefore, the placing on the market, the putting into service, or the use
        of AI systems intended to be used to detect the emotional state of individuals
        in situations related to the workplace and education should be prohibited.
        That prohibition should not cover AI systems placed on the market strictly
        for medical or safety reasons, such as systems intended for therapeutical
        use.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-45
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 45
      description: Practices that are prohibited by Union law, including data protection
        law, non- discrimination law, consumer protection law, and competition law,
        should not be affected by this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-46
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 46
      description: "High-risk AI systems should only be placed on the Union market,\
        \ put into service or used if they comply with certain mandatory requirements.\
        \ Those requirements should ensure that high-risk AI systems available in\
        \ the Union or whose output is otherwise used in the Union do not pose unacceptable\
        \ risks to important Union public interests as recognised and protected by\
        \ Union law. Based on the New Legislative Framework, as clarified in the Commission\
        \ notice \u201CThe \u2018Blue Guide\u2019 on the implementation of EU product\
        \ rules 2022\u201D, the general rule is that Union harmonisation legislation,\
        \ such as Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament\
        \ and of the Council and Directive 2006/42/EC of the European Parliament and\
        \ of the Council, may be applicable to one product, since the making available\
        \ or putting into service can take place only when the product complies with\
        \ all applicable Union harmonisation legislation. To ensure consistency and\
        \ avoid an unnecessary administrative burden or unnecessary costs, providers\
        \ of a product that contains one or more high-risk AI system, to which the\
        \ requirements of this Regulation or of the Union harmonisation legislation\
        \ listed in an annex to this Regulation apply, should be flexible with regard\
        \ to operational decisions on how to ensure compliance of a product that contains\
        \ one or more AI systems with all applicable requirements of the Union harmonisation\
        \ legislation in an optimal manner. AI systems identified as high-risk should\
        \ be limited to those that have a significant harmful impact on the health,\
        \ safety and fundamental rights of persons in the Union and such limitation\
        \ minimises any potential restriction to international trade."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-47
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 47
      description: 'AI systems could have an adverse impact to health and safety of
        persons, in particular when such systems operate as safety components. Consistently
        with the objectives of Union harmonisation legislation to facilitate the free
        movement of products in the internal market and to ensure that only safe and
        otherwise compliant products find their way into the market, it is important
        that the safety risks that may be generated by a product as a whole due to
        its digital components, including AI systems, are duly prevented and mitigated.
        For instance, increasingly autonomous robots, whether in the context of manufacturing
        or personal assistance and care should be able to safely operate and performs
        their functions in complex environments. Similarly, in the health sector where
        the stakes for life and health are particularly high, increasingly sophisticated
        diagnostics systems and systems supporting human decisions should be reliable
        and accurate. '
    - urn: urn:intuitem:risk:req_node:ai-act:recital-48
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 48
      description: "The extent of the adverse impact caused by the AI system on the\
        \ fundamental rights protected by the Charter is of particular relevance when\
        \ classifying an AI system as high risk. Those rights include the right to\
        \ human dignity, respect for private and family life, protection of personal\
        \ data, freedom of expression and information, freedom of assembly and of\
        \ association, and non-discrimination, right to education consumer protection,\
        \ workers\u2019 rights, rights of persons with disabilities, gender equality,\
        \ intellectual property rights, right to an effective remedy and to a fair\
        \ trial, right of defence and the presumption of innocence, right to good\
        \ administration. In addition to those rights, it is important to highlight\
        \ the fact that children have specific rights as enshrined in Article 24 of\
        \ the Charter and in the United Nations Convention on the Rights of the Child,\
        \ further developed in the UNCRC General Comment No 25 as regards the digital\
        \ environment, both of which require consideration of the children\u2019s\
        \ vulnerabilities and provision of such protection and care as necessary for\
        \ their well- being. The fundamental right to a high level of environmental\
        \ protection enshrined in the Charter and implemented in Union policies should\
        \ also be considered when assessing the severity of the harm that an AI system\
        \ can cause, including in relation to the health and safety of persons."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-49
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 49
      description: As regards high-risk AI systems that are safety components of products
        or systems, or which are themselves products or systems falling within the
        scope of Regulation (EC) No 300/2008 of the European Parliament and of the
        Council, Regulation (EU) No 167/2013 of the European Parliament and of the
        Council, Regulation (EU) No 168/2013 of the European Parliament and of the
        Council, Directive 2014/90/EU of the European Parliament and of the Council,
        Directive (EU) 2016/797 of the European Parliament and of the Council, Regulation
        (EU) 2018/858 of the European Parliament and of the Council,Regulation (EU)
        2018/1139 of the European Parliament and of the Council, and Regulation (EU)
        2019/2144 of the European Parliament and of the Council, it is appropriate
        to amend those acts to ensure that the Commission takes into account, on the
        basis of the technical and regulatory specificities of each sector, and without
        interfering with existing governance, conformity assessment and enforcement
        mechanisms and authorities established therein, the mandatory requirements
        for high-risk AI systems laid down in this Regulation when adopting any relevant
        delegated or implementing acts on the basis of those acts.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-50
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 50
      description: As regards AI systems that are safety components of products, or
        which are themselves products, falling within the scope of certain Union harmonisation
        legislation, it is appropriate to classify them as high-risk under this Regulation
        if the product concerned undergoes the conformity assessment procedure with
        a third-party conformity assessment body pursuant to that relevant Union harmonisation
        legislation. In particular, such products are machinery, toys, lifts, equipment
        and protective systems intended for use in potentially explosive atmospheres,
        radio equipment, pressure equipment, recreational craft equipment, cableway
        installations, appliances burning gaseous fuels, medical devices, and in vitro
        diagnostic medical devices.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-51
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 51
      description: The classification of an AI system as high-risk pursuant to this
        Regulation should not necessarily mean that the product whose safety component
        is the AI system, or the AI system itself as a product, is considered to be
        high-risk under the criteria established in the relevant Union harmonisation
        legislation that applies to the product. This is, in particular, the case
        for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity
        assessment is provided for medium-risk and high-risk products.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-52
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 52
      description: As regards stand-alone AI systems, namely high-risk AI systems
        other than those that are safety components, or which are themselves products,
        it is appropriate to classify them as high-risk if, in the light of their
        intended purpose, they pose a high risk of harm to the health and safety or
        the fundamental rights of persons, taking into account both the severity of
        the possible harm and its probability of occurrence and they are used in a
        number of specifically pre-defined areas specified in this Regulation. The
        identification of those systems is based on the same methodology and criteria
        envisaged also for any future amendments of the list of high-risk AI systems
        that the Commission should be empowered to adopt, via delegated acts, to take
        into account the rapid pace of technological development, as well as the potential
        changes in the use of AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-53
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 53
      description: "It is also important to clarify that there may be specific cases\
        \ in which AI systems referred to pre-defined areas specified in this Regulation\
        \ do not lead to a significant risk of harm to the legal interests protected\
        \ under those areas because they do not materially influence the decision-making\
        \ or do not harm those interests substantially. For the purposes of this Regulation\
        \ an AI system that does not materially influence the outcome of decision-making\
        \ should be understood to be an AI system that does not have an impact on\
        \ the substance, and thereby the outcome, of decision-making, whether human\
        \ or automated. An AI system that does not materially influence the outcome\
        \ of decision- making could include situations in which one or more of the\
        \ following conditions are fulfilled. The first such condition should be that\
        \ the AI system is intended to perform a narrow procedural task, such as an\
        \ AI system that transforms unstructured data into structured data, an AI\
        \ system that classifies incoming documents into categories or an AI system\
        \ that is used to detect duplicates among a large number of applications.\
        \ Those tasks are of such narrow and limited nature that they pose only limited\
        \ risks which are not increased through the use in a context that is listed\
        \ as a high-risk use in an annex to this Regulation. The second condition\
        \ should be that the task performed by the AI system is intended to improve\
        \ the result of a previously completed human activity that may be relevant\
        \ for the purposes of that list. Considering those characteristics, the AI\
        \ system provides only an additional layer to a human activity with consequently\
        \ lowered risk. That condition would, for example, apply to AI systems that\
        \ are intended to improve the language used in previously drafted documents,\
        \ for instance in relation to professional tone, academic style of language\
        \ or by aligning text to a certain brand messaging. \nThe third condition\
        \ should be that the AI system is intended to detect decision-making patterns\
        \ or deviations from prior decision-making patterns. The risk would be lowered\
        \ because the use of the AI system follows a previously completed human assessment\
        \ which it is not meant to replace or influence, without proper human review.\
        \ Such AI systems include for instance those that, given a certain grading\
        \ pattern of a teacher, can be used to check ex post whether the teacher may\
        \ have deviated from the grading pattern so as to flag potential inconsistencies\
        \ or anomalies. The fourth condition should be that the AI system is intended\
        \ to perform a task that is only preparatory to an assessment relevant for\
        \ the purposes of the AI systems listed in an annex to this Regulation, thus\
        \ making the possible impact of the output of the system very low in terms\
        \ of representing a risk for the assessment to follow. That condition covers,\
        \ inter alia, smart solutions for file handling, which include various functions\
        \ from indexing, searching, text and speech processing or linking data to\
        \ other data sources, or AI systems used for translation of initial documents.\
        \ In any case, those high-risk AI systems should be considered to pose significant\
        \ risks of harm to the health, safety or fundamental rights of natural persons\
        \ if the AI system implies profiling within the meaning of Article 4, point\
        \ (4) of Regulation (EU) 2016/679 or Article 3, point (4) of Directive (EU)\
        \ 2016/680 or Article 3, point (5) of Regulation (EU) 2018/1725. To ensure\
        \ traceability and transparency, a provider who considers that an AI systems\
        \ is not high-risk on the basis of those conditions should draw up documentation\
        \ of the assessment before that system is placed on the market or put into\
        \ service and should provide this documentation to national competent authorities\
        \ upon request. Such a provider should be obliged to register the system in\
        \ the EU database established under this Regulation. With a view to provide\
        \ further guidance for the practical implementation of the conditions under\
        \ which the high-risk AI systems listed in the annex are, on an exceptional\
        \ basis, non-high-risk, the Commission should, after consulting the Board,\
        \ provide guidelines specifying that practical implementation completed by\
        \ a comprehensive list of practical examples of use cases of AI systems that\
        \ are high-risk and not high-risk."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-54
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 54
      description: As biometric data constitutes a special category of sensitive personal
        data, it is appropriate to classify as high-risk several critical-use cases
        of biometric systems, insofar as their use is permitted under relevant Union
        and national law. Technical inaccuracies of AI systems intended for the remote
        biometric identification of natural persons can lead to biased results and
        entail discriminatory effects. The risk of such biased results and discriminatory
        effects are particularly relevant with regard to age, ethnicity, race, sex
        or disabilities. Remote biometric identification systems should therefore
        be classified as high-risk in view of the risks that they pose. Such classification
        excludes AI systems intended to be used for biometric verification, including
        authentication, the sole purpose of which is to confirm that a specific natural
        person who he or she claims to be and to confirm the identity of a natural
        person for the sole purpose of having access to a service, unlocking a device
        or having secure access to premises. In addition, AI systems intended to be
        used for biometric categorisation according to sensitive attributes or characteristics
        protected under Article 9(1) of Regulation (EU) 2016/679 on the basis of biometric
        data, in so far as these are not prohibited under this Regulation, and emotion
        recognition systems that are not prohibited under this Regulation, should
        be classified as high-risk. Biometric systems which are intended to be used
        solely for the purpose of enabling cybersecurity and personal data protection
        measures should not be considered to be high-risk systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-55
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 55
      description: As regards the management and operation of critical infrastructure,
        it is appropriate to classify as high-risk the AI systems intended to be used
        as safety components in the management and operation of critical digital infrastructure
        as listed in Annex I, point (8),to Directive (EU) 2022/2557, road traffic
        and the supply of water, gas, heating and electricity, since their failure
        or malfunctioning may put at risk the life and health of persons at large
        scale and lead to appreciable disruptions in the ordinary conduct of social
        and economic activities. Safety components of critical infrastructure, including
        critical digital infrastructure, are systems used to directly protect the
        physical integrity of critical infrastructure or health and safety of persons
        and property but which are not necessary in order for the system to function.
        The failure or malfunctioning of such components might directly lead to risks
        to the physical integrity of critical infrastructure and thus to risks to
        health and safety of persons and property. Components intended to be used
        solely for cybersecurity purposes should not qualify as safety components.
        Examples of safety components of such critical infrastructure may include
        systems for monitoring water pressure or fire alarm controlling systems in
        cloud computing centres.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-56
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 56
      description: "The deployment of AI systems in education is important to promote\
        \ high-quality digital education and training and to allow all learners and\
        \ teachers to acquire and share the necessary digital skills and competences,\
        \ including media literacy, and critical thinking, to take an active part\
        \ in the economy, society, and in democratic processes. However, AI systems\
        \ used in education or vocational training, in particular for determining\
        \ access or admission, for assigning persons to educational and vocational\
        \ training institutions or programmes at all levels, for evaluating learning\
        \ outcomes of persons, for assessing the appropriate level of education for\
        \ an individual and materially influencing the level of education and training\
        \ that individuals will receive or will be able to access or for monitoring\
        \ and detecting prohibited behaviour of students during tests should be classified\
        \ as high-risk AI systems, since they may determine the educational and professional\
        \ course of a person\u2019s life and therefore affect that person\u2019s ability\
        \ to secure a livelihood. When improperly designed and used, such systems\
        \ may be particularly intrusive and may violate the right to education and\
        \ training as well as the right not to be discriminated against and perpetuate\
        \ historical patterns of discrimination, for example against women, certain\
        \ age groups, persons with disabilities, or persons of certain racial or ethnic\
        \ origins or sexual orientation."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-57
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 57
      description: "AI systems used in employment, workers management and access to\
        \ self-employment, in particular for the recruitment and selection of persons,\
        \ for making decisions affecting terms of the work related relationship promotion\
        \ and termination of work-related contractual relationships for allocating\
        \ tasks on the basis of individual behaviour, personal traits or characteristics\
        \ and for monitoring or evaluation of persons in work- related contractual\
        \ relationships, should also be classified as high-risk, since those systems\
        \ may have an appreciable impact on future career prospects, livelihoods of\
        \ those persons and workers\u2019 rights. Relevant work-related contractual\
        \ relationships should, in a meaningful manner, involve employees and persons\
        \ providing services through platforms as referred to in the Commission Work\
        \ Programme 2021.  Throughout the recruitment process and in the evaluation,\
        \ promotion, or retention of persons in work-related contractual relationships,\
        \ such systems may perpetuate historical patterns of discrimination, for example\
        \ against women, certain age groups, persons with disabilities, or persons\
        \ of certain racial or ethnic origins or sexual orientation. AI systems used\
        \ to monitor the performance and behaviour of such persons may also undermine\
        \ their fundamental rights to data protection and privacy."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-58
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 58
      description: "Another area in which the use of AI systems deserves special consideration\
        \ is the access to and enjoyment of certain essential private and public services\
        \ and benefits necessary for people to fully participate in society or to\
        \ improve one\u2019s standard of living. In particular, natural persons applying\
        \ for or receiving essential public assistance benefits and services from\
        \ public authorities namely healthcare services, social security benefits,\
        \ social services providing protection in cases such as maternity, illness,\
        \ industrial accidents, dependency or old age and loss of employment and social\
        \ and housing assistance, are typically dependent on those benefits and services\
        \ and in a vulnerable position in relation to the responsible authorities.\
        \ If AI systems are used for determining whether such benefits and services\
        \ should be granted, denied, reduced, revoked or reclaimed by authorities,\
        \ including whether beneficiaries are legitimately entitled to such benefits\
        \ or services, those systems may have a significant impact on persons\u2019\
        \ livelihood and may infringe their fundamental rights, such as the right\
        \ to social protection, non-discrimination, human dignity or an effective\
        \ remedy and should therefore be classified as high-risk. Nonetheless, this\
        \ Regulation should not hamper the development and use of innovative approaches\
        \ in the public administration, which would stand to benefit from a wider\
        \ use of compliant and safe AI systems, provided that those systems do not\
        \ entail a high risk to legal and natural persons.\nIn addition, AI systems\
        \ used to evaluate the credit score or creditworthiness of natural persons\
        \ should be classified as high-risk AI systems, since they determine those\
        \ persons\u2019 access to financial resources or essential services such as\
        \ housing, electricity, and telecommunication services. AI systems used for\
        \ those purposes may lead to discrimination between persons or groups and\
        \ may perpetuate historical patterns of discrimination, such as that based\
        \ on racial or ethnic origins, gender, disabilities, age or sexual orientation,\
        \ or may create new forms of discriminatory impacts. However, AI systems provided\
        \ for by Union law for the purpose of detecting fraud in the offering of financial\
        \ services and for prudential purposes to calculate credit institutions\u2019\
        \ and insurances undertakings\u2019 capital requirements should not be considered\
        \ to be high-risk under this Regulation. Moreover, AI systems intended to\
        \ be used for risk assessment and pricing in relation to natural persons for\
        \ health and life insurance can also have a significant impact on persons\u2019\
        \ livelihood and if not duly designed, developed and used, can infringe their\
        \ fundamental rights and can lead to serious consequences for people\u2019\
        s life and health, including financial exclusion and discrimination. Finally,\
        \ AI systems used to evaluate and classify emergency calls by natural persons\
        \ or to dispatch or establish priority in the dispatching of emergency first\
        \ response services, including by police, firefighters and medical aid, as\
        \ well as of emergency healthcare patient triage systems, should also be classified\
        \ as high-risk since they make decisions in very critical situations for the\
        \ life and health of persons and their property."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-59
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 59
      description: "Given their role and responsibility, actions by law enforcement\
        \ authorities involving certain uses of AI systems are characterised by a\
        \ significant degree of power imbalance and may lead to surveillance, arrest\
        \ or deprivation of a natural person\u2019s liberty as well as other adverse\
        \ impacts on fundamental rights guaranteed in the Charter. In particular,\
        \ if the AI system is not trained with high-quality data, does not meet adequate\
        \ requirements in terms of its performance, its accuracy or robustness, or\
        \ is not properly designed and tested before being put on the market or otherwise\
        \ put into service, it may single out people in a discriminatory or otherwise\
        \ incorrect or unjust manner. Furthermore, the exercise of important procedural\
        \ fundamental rights, such as the right to an effective remedy and to a fair\
        \ trial as well as the right of defence and the presumption of innocence,\
        \ could be hampered, in particular, where such AI systems are not sufficiently\
        \ transparent, explainable and documented. It is therefore appropriate to\
        \ classify as high-risk, insofar as their use is permitted under relevant\
        \ Union and national law, a number of AI systems intended to be used in the\
        \ law enforcement context where accuracy, reliability and transparency is\
        \ particularly important to avoid adverse impacts, retain public trust and\
        \ ensure accountability and effective redress.\nIn view of the nature of the\
        \ activities and the risks relating thereto, those high-risk AI systems should\
        \ include in particular AI systems intended to be used by or on behalf of\
        \ law enforcement authorities or by Union bodies, offices, or agencies in\
        \ support of law enforcement authorities for assessing the risk of a natural\
        \ person to become a victim of criminal offences, as polygraphs and similar\
        \ tools, for the evaluation of the reliability of evidence in in the course\
        \ of investigation or prosecution of criminal offences, and, insofar not prohibited\
        \ under this Regulation, for assessing the risk of a natural person offending\
        \ or reoffending not solely on the basis of the profiling of natural persons\
        \ or the assessment of personality traits and characteristics or the past\
        \ criminal behaviour of natural persons or groups, for profiling in the course\
        \ of detection, investigation or prosecution of criminal offences . AI systems\
        \ specifically intended to be used for administrative proceedings by tax and\
        \ customs authorities as well as by financial intelligence units carrying\
        \ out administrative tasks analysing information pursuant to Union anti-money\
        \ laundering law should not be classified as high-risk AI systems used by\
        \ law enforcement authorities for the purpose of prevention, detection, investigation\
        \ and prosecution of criminal offences. The use of AI tools by law enforcement\
        \ and authorities should not become a factor of inequality, or exclusion.\
        \ The impact of the use of AI tools on the defence rights of suspects should\
        \ not be ignored, in particular the difficulty in obtaining meaningful information\
        \ on the functioning of those systems and the resulting difficulty in challenging\
        \ their results in court, in particular by natural persons under investigation."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-60
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 60
      description: 'AI systems used in migration, asylum and border control management
        affect people who are often in particularly vulnerable position and who are
        dependent on the outcome of the actions of the competent public authorities.
        The accuracy, non-discriminatory nature and transparency of the AI systems
        used in those contexts are therefore particularly important to guarantee respect
        for the fundamental rights of the affected persons, in particular their rights
        to free movement, non-discrimination, protection of private life and personal
        data, international protection and good administration. It is therefore appropriate
        to classify as high-risk, insofar as their use is permitted under relevant
        Union and national law AI systems intended to be used by or on behalf of competent
        public authorities or by Union institutions, bodies, offices or agencies charged
        with tasks in the fields of migration, asylum and border control management
        as polygraphs and similar tools, for assessing certain risks posed by natural
        persons entering the territory of a Member State or applying for visa or asylum,
        for assisting competent public authorities for the examination, including
        related assessment of the reliability of evidence, of applications for asylum,
        visa and residence permits and associated complaints with regard to the objective
        to establish the eligibility of the natural persons applying for a status,
        for the purpose of detecting, recognising or identifying natural persons in
        the context of migration, asylum and border control management with the exception
        of verification of travel documents.

        AI systems in the area of migration, asylum and border control management
        covered by this Regulation should comply with the relevant procedural requirements
        set by the Regulation (EC) No 810/2009 of the European Parliament and of the
        Council, the Directive 2013/32/EU of the European Parliament and of the Council,
        and other relevant Union law. The use of AI systems in migration, asylum and
        border control management should, in no circumstances, be used by Member States
        or Union institutions, bodies, offices or agencies as a means to circumvent
        their international obligations under the UN Convention relating to the Status
        of Refugees done at Geneva on 28 July 1951 as amended by the Protocol of 31
        January 1967. Nor should they be used to in any way infringe on the principle
        of non-refoulement, or to deny safe and effective legal avenues into the territory
        of the Union, including the right to international protection.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-61
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 61
      description: 'Certain AI systems intended for the administration of justice
        and democratic processes should be classified as high-risk, considering their
        potentially significant impact on democracy, the rule of law, individual freedoms
        as well as the right to an effective remedy and to a fair trial. In particular,
        to address the risks of potential biases, errors and opacity, it is appropriate
        to qualify as high-risk AI systems intended to be used by a judicial authority
        or on its behalf to assist judicial authorities in researching and interpreting
        facts and the law and in applying the law to a concrete set of facts. AI systems
        intended to be used by alternative dispute resolution bodies for those purposes
        should also be considered to be high-risk when the outcomes of the alternative
        dispute resolution proceedings produce legal effects for the parties. The
        use of AI tools can support the decision-making power of judges or judicial
        independence, but should not replace it: the final decision-making must remain
        a human-driven activity. The classification of AI systems as high-risk should
        not, however, extend to AI systems intended for purely ancillary administrative
        activities that do not affect the actual administration of justice in individual
        cases, such as anonymisation or pseudonymisation of judicial decisions, documents
        or data, communication between personnel, administrative tasks .'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-62
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 62
      description: Without prejudice to the rules provided for in Regulation (EU)
        2024/900 of the European Parliament and of the Council, and in order to address
        the risks of undue external interference to the right to vote enshrined in
        Article 39 of the Charter, and of adverse effects on democracy and the rule
        of law, AI systems intended to be used to influence the outcome of an election
        or referendum or the voting behaviour of natural persons in the exercise of
        their vote in elections or referenda should be classified as high-risk AI
        systems with the exception of AI systems whose output natural persons are
        not directly exposed to, such as tools used to organise, optimise and structure
        political campaigns from an administrative and logistical point of view.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-63
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 63
      description: The fact that an AI system is classified as a high-risk AI system
        under this Regulation should not be interpreted as indicating that the use
        of the system is lawful under other acts of Union law or under national law
        compatible with Union law, such as on the protection of personal data, on
        the use of polygraphs and similar tools or other systems to detect the emotional
        state of natural persons. Any such use should continue to occur solely in
        accordance with the applicable requirements resulting from the Charter and
        from the applicable acts of secondary Union law and national law. This Regulation
        should not be understood as providing for the legal ground for processing
        of personal data, including special categories of personal data, where relevant,
        unless it is specifically otherwise provided for in this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-64
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 64
      description: "To mitigate the risks from high-risk AI systems placed on the\
        \ market or put into service and to ensure a high level of trustworthiness,\
        \ certain mandatory requirements should apply to high-risk AI systems, taking\
        \ into account the intended purpose and the context of use of the AI system\
        \ and according to the risk-management system to be established by the provider.\
        \ The measures adopted by the providers to comply with the mandatory requirements\
        \ of this Regulation should take into account the generally acknowledge state\
        \ of the art on AI, be proportionate and effective to meet the objectives\
        \ of this Regulation. Based on the New Legislative Framework, as clarified\
        \ in Commission notice \u201CThe \u2018Blue Guide\u2019 on the implementation\
        \ of EU product rules 2022\u201D, the general rule is that Union harmonisation\
        \ legislation may be applicable to one product, since the making available\
        \ or putting into service can take place only when the product complies with\
        \ all applicable Union harmonisation legislation. The hazards of AI systems\
        \ covered by the requirements of this Regulation concern different aspects\
        \ than the existing Union harmonisation acts and therefore the requirements\
        \ of this Regulation would complement the existing body of the Union harmonisation\
        \ acts. For example, machinery or medical devices products incorporating an\
        \ AI system might present risks not addressed by the essential health and\
        \ safety requirements set out in the relevant Union harmonised legislation,\
        \ as that sectoral law does not deal with risks specific to AI systems.\n\
        This calls for a simultaneous and complementary application of the various\
        \ legislative acts. To ensure consistency and to avoid an unnecessary administrative\
        \ burden and unnecessary costs, providers of a product that contains one or\
        \ more high-risk AI system, to which the requirements of this Regulation and\
        \ of the Union harmonisation legislation based on the New Legislative Framework\
        \ listed in an annex to this Regulation apply, should be flexible with regard\
        \ to operational decisions on how to ensure compliance of a product that contains\
        \ one or more AI systems with all the applicable requirements of that Union\
        \ harmonised legislation in an optimal manner. That flexibility could mean,\
        \ for example a decision by the provider to integrate a part of the necessary\
        \ testing and reporting processes, information and documentation required\
        \ under this Regulation into already existing documentation and procedures\
        \ required under existing Union harmonisation legislation based on the New\
        \ Legislative Framework listed in an annex to this Regulation. This should\
        \ not, in any way, undermine the obligation of the provider to comply with\
        \ all the applicable requirements."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-65
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 65
      description: 'The risk-management system should consist of a continuous, iterative
        process that is planned and run throughout the entire lifecycle of a high-risk
        AI system. This process should be aimed at identifying and mitigating the
        relevant risks of AI systems on health, safety and fundamental rights. The
        risk-management system should be regularly reviewed and updated to ensure
        its continuing effectiveness, as well as justification and documentation of
        any significant decisions and actions taken subject to this Regulation. This
        process should ensure that the provider identifies risks or adverse impacts
        and implements mitigation measures for the known and reasonably foreseeable
        risks of AI systems to the health, safety and fundamental rights in light
        of its intended purpose and reasonably foreseeable misuse, including the possible
        risks arising from the interaction between the AI system and the environment
        within which it operates. The risk- management system should adopt the most
        appropriate risk-management measures in the light of the state of the art
        in AI. When identifying the most appropriate risk- management measures, the
        provider should document and explain the choices made and, when relevant,
        involve experts and external stakeholders. In identifying the reasonably foreseeable
        misuse of high-risk AI systems, the provider should cover uses of AI systems
        which, while not directly covered by the intended purpose and provided for
        in the instruction for use may nevertheless be reasonably expected to result
        from readily predictable human behaviour in the context of the specific characteristics
        and use of a particular AI system.

        Any known or foreseeable circumstances related to the use of the high-risk
        AI system in accordance with its intended purpose or under conditions of reasonably
        foreseeable misuse, which may lead to risks to the health and safety or fundamental
        rights should be included in the instructions for use provided by the provider.
        This is to ensure that the deployer is aware and takes them into account when
        using the high-risk AI system. Identifying and implementing risk mitigation
        measures for foreseeable misuse under this Regulation should not require specific
        additional training measures for the high-risk AI system by the provider to
        address them. The providers however are encouraged to consider such additional
        training measures to mitigate reasonable foreseeable misuses as necessary
        and appropriate.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-66
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 66
      description: Requirements should apply to high-risk AI systems as regards risk
        management, the quality and relevance of data sets used, technical documentation
        and record-keeping, transparency and the provision of information to deployers,
        human oversight, and robustness, accuracy and cybersecurity. Those requirements
        are necessary to effectively mitigate the risks for health, safety and fundamental
        rights, and no other less trade restrictive measures are reasonably available,
        thus avoiding unjustified restrictions to trade.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-67
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 67
      description: 'High-quality data and access to high-quality data plays a vital
        role in providing structure and in ensuring the performance of many AI systems,
        especially when techniques involving the training of models are used, with
        a view to ensure that the high-risk AI system performs as intended and safely
        and it does not become a source of discrimination prohibited by Union law.
        High-quality data sets for training, validation and testing require the implementation
        of appropriate data governance and management practices. Data sets for training,
        validation and testing, including the labels, should be relevant, sufficiently
        representative, and to the best extent possible free of errors and complete
        in view of the intended purpose of the system. In order to facilitate compliance
        with Union data protection law, such as Regulation (EU) 2016/679, data governance
        and management practices should include, in the case of personal data, transparency
        about the original purpose of the data collection. The data sets should also
        have the appropriate statistical properties, including as regards the persons
        or groups of persons in relation to whom the high-risk AI system is intended
        to be used, with specific attention to the mitigation of possible biases in
        the data sets, that are likely to affect the health and safety of persons,
        have a negative impact on fundamental rights or lead to discrimination prohibited
        under Union law, especially where data outputs influence inputs for future
        operations (feedback loops). Biases can for example be inherent in underlying
        data sets, especially when historical data is being used, or generated when
        the systems are implemented in real world settings.

        Results provided by AI systems could be influenced by such inherent biases
        that are inclined to gradually increase and thereby perpetuate and amplify
        existing discrimination, in particular for vulnerable persons belonging to
        certain groups, including racial or ethnic groups. The requirement for the
        data sets to be to the best extent possible complete and free of errors should
        not affect the use of privacy- preserving techniques in the context of the
        development and testing of AI systems. In particular, data sets should take
        into account, to the extent required by their intended purpose, the features,
        characteristics or elements that are particular to the specific geographical,
        contextual, behavioural or functional setting which the AI system is intended
        to be used. The requirements related to data governance can be complied with
        by having recourse to third-parties that offer certified compliance services
        including verification of data governance, data set integrity, and data training,
        validation and testing practices, as far as compliance with the data requirements
        of this Regulation are ensured.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-68
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 68
      description: For the development and assessment of high-risk AI systems, certain
        actors, such as providers, notified bodies and other relevant entities, such
        as European Digital Innovation Hubs, testing experimentation facilities and
        researchers, should be able to access and use high-quality data sets within
        the fields of activities of those actors which are related to this Regulation.
        European common data spaces established by the Commission and the facilitation
        of data sharing between businesses and with government in the public interest
        will be instrumental to provide trustful, accountable and non-discriminatory
        access to high- quality data for the training, validation and testing of AI
        systems. For example, in health, the European health data space will facilitate
        non-discriminatory access to health data and the training of AI algorithms
        on those data sets, in a privacy-preserving, secure, timely, transparent and
        trustworthy manner, and with an appropriate institutional governance. Relevant
        competent authorities, including sectoral ones, providing or supporting the
        access to data may also support the provision of high-quality data for the
        training, validation and testing of AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-69
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 69
      description: The right to privacy and to protection of personal data must be
        guaranteed throughout the entire lifecycle of the AI system. In this regard,
        the principles of data minimisation and data protection by design and by default,
        as set out in Union data protection law, are applicable when personal data
        are processed. Measures taken by providers to ensure compliance with those
        principles may include not only anonymisation and encryption, but also the
        use of technology that permits algorithms to be brought to the data and allows
        training of AI systems without the transmission between parties or copying
        of the raw or structured data themselves, without prejudice to the requirements
        on data governance provided for in this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-70
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 70
      description: In order to protect the right of others from the discrimination
        that might result from the bias in AI systems, the providers should, exceptionally,
        to the extent that it is strictly necessary for the purpose of ensuring bias
        detection and correction in relation to the high-risk AI systems, subject
        to appropriate safeguards for the fundamental rights and freedoms of natural
        persons and following the application of all applicable conditions laid down
        under this Regulation in addition to the conditions laid down in Regulations
        (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, be able to process
        also special categories of personal data, as a matter of substantial public
        interest within the meaning of Article 9(2), point (g) of Regulation (EU)
        2016/679 and Article 10(2), point (g) of Regulation (EU) 2018/1725.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-71
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 71
      description: Having comprehensible information on how high-risk AI systems have
        been developed and how they perform throughout their lifetime is essential
        to enable traceability of those systems, verify compliance with the requirements
        under this Regulation, as well as monitoring of their operations and post
        market monitoring. This requires keeping records and the availability of a
        technical documentation, containing information which is necessary to assess
        the compliance of the AI system with the relevant requirements and facilitate
        post market monitoring. Such information should include the general characteristics,
        capabilities and limitations of the system, algorithms, data, training, testing
        and validation processes used as well as documentation on the relevant risk-management
        system and drawn in a clear and comprehensive form. The technical documentation
        should be kept up to date, appropriately throughout the lifetime of the AI
        system. Furthermore, high-risk AI systems should technically allow for the
        automatic recording of events, by means of logs, over the duration of the
        lifetime of the system.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-72
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 72
      description: To address concerns related to opacity and complexity of certain
        AI systems and help deployers to fulfil their obligations under this Regulation,
        transparency should be required for high-risk AI systems before they are placed
        on the market or put it into service. High-risk AI systems should be designed
        in a manner to enable deployers to understand how the AI system works, evaluate
        its functionality, and comprehend its strengths and limitations. High-risk
        AI systems, should  be accompanied by appropriate information in the form
        of instructions of use. Such information should include the characteristics,
        capabilities and limitations of performance of the AI system. Such elements
        would cover information on possible known or foreseeable circumstances related
        to the use of the high-risk AI system, including deployer action that may
        influence system behaviour and performance, under which the AI system can
        lead to risks to health, safety, and fundamental rights, on the changes that
        have been pre- determined and assessed for conformity by the provider and
        on the relevant human oversight measures, including the measures to facilitate
        the interpretation of the outputs of the AI system by the deployers. Transparency,
        including the accompanying instructions for use, should assist deployers in
        the use of the system and support informed decision making by them. Among
        others, deployers should be in a better position to make the correct choice
        of the system they intend to use in the light of the obligations applicable
        to them, be educated about the intended and precluded uses, and use the AI
        system correctly and as appropriate. In order to enhance legibility and accessibility
        of the information included in the instructions of use, where appropriate,
        illustrative examples, for instance on the limitations and on the intended
        and precluded uses of the AI system, should be included. Providers should
        ensure that all documentation, including the instructions for use, contains
        meaningful, comprehensive, accessible and understandable information, taking
        into account the needs and foreseeable knowledge of the target deployers.
        Instructions for use should be made available in a language which can be easily
        understood by target deployers, as determined by the Member State concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-73
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 73
      description: "High-risk AI systems should be designed and developed in such\
        \ a way that natural persons can oversee their functioning, ensure that they\
        \ are used as intended and that their impacts are addressed over the system\u2019\
        s lifecycle. For this purpose, appropriate human oversight measures should\
        \ be identified by the provider of the system before its placing on the market\
        \ or putting into service. In particular, where appropriate, such measures\
        \ should guarantee that the system is subject to in-built operational constraints\
        \ that cannot be overridden by the system itself and is responsive to the\
        \ human operator, and that the natural persons to whom human oversight has\
        \ been assigned have the necessary competence, training and authority to carry\
        \ out that role. It is also essential, as appropriate, to ensure that high-risk\
        \ AI systems include mechanisms to guide and inform a natural person to whom\
        \ human oversight has been assigned to make informed decisions if, when and\
        \ how to intervene in order to avoid negative consequences or risks, or stop\
        \ the system if it does not perform as intended. Considering the significant\
        \ consequences for persons in the case of an incorrect match by certain biometric\
        \ identification systems, it is appropriate to provide for an enhanced human\
        \ oversight requirement for those systems so that no action or decision may\
        \ be taken by the deployer on the basis of the identification resulting from\
        \ the system unless this has been separately verified and confirmed by at\
        \ least two natural persons. Those persons could be from one or more entities\
        \ and include the person operating or using the system. This requirement should\
        \ not pose unnecessary burden or delays and it could be sufficient that the\
        \ separate verifications by the different persons are automatically recorded\
        \ in the logs generated by the system. Given the specificities of the areas\
        \ of law enforcement, migration, border control and asylum, this requirement\
        \ should not apply where Union or national law considers the application of\
        \ that requirement to be disproportionate."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-74
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 74
      description: High-risk AI systems should perform consistently throughout their
        lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity,
        in the light of their intended purpose and in accordance with the generally
        acknowledged state of the art. The Commission and relevant organisations and
        stakeholders are encouraged to take due consideration of the mitigation of
        risks and the negative impacts of the AI system. The expected level of performance
        metrics should be declared in the accompanying instructions of use. Providers
        are urged to communicate that information to deployers in a clear and easily
        understandable way, free of misunderstandings or misleading statements. Union
        law on legal metrology, including Directives 2014/31/EU36 and 2014/32/EU37
        of the European Parliament and of the Council, aims to ensure the accuracy
        of measurements and to help the transparency and fairness of commercial transactions.
        In that context, in cooperation with relevant stakeholders and organisation,
        such as metrology and benchmarking authorities, the Commission should encourage,
        as appropriate, the development of benchmarks and measurement methodologies
        for AI systems. In doing so, the Commission should take note and collaborate
        with international partners working on metrology and relevant measurement
        indicators relating to AI.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-75
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 75
      description: The technical robustness is a key requirement for high-risk AI
        systems. They should be resilient in relation to harmful or otherwise undesirable
        behaviour that may result from limitations within the systems or the environment
        in which the systems operate (e.g. errors, faults, inconsistencies, unexpected
        situations). Therefore, technical and organisational measures should be taken
        to ensure robustness of high-risk AI systems, for example by designing and
        developing appropriate technical solutions to prevent or minimize harmful
        or otherwise undesirable behaviour. Those technical solution may include for
        instance mechanisms enabling the system to safely interrupt its operation
        (fail-safe plans) in the presence of certain anomalies or when operation takes
        place outside certain predetermined boundaries. Failure to protect against
        these risks could lead to safety impacts or negatively affect the fundamental
        rights, for example due to erroneous decisions or wrong or biased outputs
        generated by the AI system.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-76
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 76
      description: "Cybersecurity plays a crucial role in ensuring that AI systems\
        \ are resilient against attempts to alter their use, behaviour, performance\
        \ or compromise their security properties by malicious third parties exploiting\
        \ the system\u2019s vulnerabilities. Cyberattacks against AI systems can leverage\
        \ AI specific assets, such as training data sets (e.g. data poisoning) or\
        \ trained models (e.g. adversarial attacks or membership inference), or exploit\
        \ vulnerabilities in the AI system\u2019s digital assets or the underlying\
        \ ICT infrastructure. To ensure a level of cybersecurity appropriate to the\
        \ risks, suitable measures, such as security controls, should therefore be\
        \ taken by the providers of high-risk AI systems, also taking into account\
        \ as appropriate the underlying ICT infrastructure."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-77
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 77
      description: Without prejudice to the requirements related to robustness and
        accuracy set out in this Regulation, high-risk AI systems which fall within
        the scope of a regulation of the European Parliament and of the Council on
        horizontal cybersecurity requirements for products with digital elements,
        in accordance with that regulation may demonstrate compliance with the cybersecurity
        requirements of this Regulation by fulfilling the essential cybersecurity
        requirements set out in that regulation. When high-risk AI systems fulfil
        the essential requirements of a regulation of the European Parliament and
        of the Council on horizontal cybersecurity requirements for products with
        digital elements, they should be deemed compliant with the cybersecurity requirements
        set out in this Regulation in so far as the achievement of those requirements
        is demonstrated in the EU declaration of conformity or parts thereof issued
        under that regulation. To that end, the assessment of the cybersecurity risks,
        associated to a product with digital elements classified as high-risk AI system
        according to this Regulation, carried out under a regulation of the European
        Parliament and of the Council on horizontal cybersecurity requirements for
        products with digital elements, should consider risks to the cyber resilience
        of an AI system as regards attempts by unauthorised third parties to alter
        its use, behaviour or performance, including AI specific vulnerabilities such
        as data poisoning or adversarial attacks, as well as, as relevant, risks to
        fundamental rights as required by this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-78
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 78
      description: The conformity assessment procedure provided by this Regulation
        should apply in relation to the essential cybersecurity requirements of a
        product with digital elements covered by a regulation of the European Parliament
        and of the Council on horizontal cybersecurity requirements for products with
        digital elements and classified as a high-risk AI system under this Regulation.
        However, this rule should not result in reducing the necessary level of assurance
        for critical products with digital elements covered by a regulation of the
        European Parliament and of the Council on horizontal cybersecurity requirements
        for products with digital elements. Therefore, by way of derogation from this
        rule, high-risk AI systems that fall within the scope of this Regulation and
        are also qualified as important and critical products with digital elements
        pursuant to a regulation of the European Parliament and of the Council on
        horizontal cybersecurity requirements for products with digital elements and
        to which the conformity assessment procedure based on internal control set
        out in an annex to this Regulation applies, are subject to the conformity
        assessment provisions of a regulation of the European Parliament and of the
        Council on horizontal cybersecurity requirements for products with digital
        elements insofar as the essential cybersecurity requirements of that regulation
        are concerned. In this case, for all the other aspects covered by this Regulation
        the respective provisions on conformity assessment based on internal control
        set out in an annex to this Regulation should apply. Building on the knowledge
        and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA
        under the Regulation (EU) 2019/881 of the European Parliament and of the Council,
        the Commission should cooperate with ENISA on issues related to cybersecurity
        of AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-79
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 79
      description: It is appropriate that a specific natural or legal person, defined
        as the provider, takes the responsibility for the placing on the market or
        the putting into service of a high-risk AI system, regardless of whether that
        natural or legal person is the person who designed or developed the system.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-80
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 80
      description: As signatories to the United Nations Convention on the Rights of
        Persons with Disabilities, the Union and the Member States are legally obliged
        to protect persons with disabilities from discrimination and promote their
        equality, to ensure that persons with disabilities have access, on an equal
        basis with others, to information and communications technologies and systems,
        and to ensure respect for privacy for persons with disabilities. Given the
        growing importance and use of AI systems, the application of universal design
        principles to all new technologies and services should ensure full and equal
        access for everyone potentially affected by or using AI technologies, including
        persons with disabilities, in a way that takes full account of their inherent
        dignity and diversity. It is therefore essential that providers ensure full
        compliance with accessibility requirements, including Directive (EU) 2016/2102
        of the European Parliament and of the Council and Directive (EU) 2019/882.
        Providers should ensure compliance with these requirements by design. Therefore,
        the necessary measures should be integrated as much as possible into the design
        of the high-risk AI system.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-81
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 81
      description: The provider should establish a sound quality management system,
        ensure the accomplishment of the required conformity assessment procedure,
        draw up the relevant documentation and establish a robust post-market monitoring
        system. Providers of high- risk AI systems that are subject to obligations
        regarding quality management systems under relevant sectorial Union law should
        have the possibility to include the elements of the quality management system
        provided for in this Regulation as part of the existing quality management
        system provided for in that other sectoral Union law. The complementarity
        between this Regulation and existing sectorial Union law should also be taken
        into account in future standardisation activities or guidance adopted by the
        Commission. Public authorities which put into service high-risk AI systems
        for their own use may adopt and implement the rules for the quality management
        system as part of the quality management system adopted at a national or regional
        level, as appropriate, taking into account the specificities of the sector
        and the competences and organisation of the public authority concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-82
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 82
      description: To enable enforcement of this Regulation and create a level-playing
        field for operators, and taking into account the different forms of making
        available of digital products, it is important to ensure that, under all circumstances,
        a person established in the Union can provide authorities with all the necessary
        information on the compliance of an AI system. Therefore, prior to making
        their AI systems available in the Union,  providers established in third countries
        shall, by written mandate, appoint an authorised representative established
        in the Union. This authorised representative plays a pivotal role in ensuring
        the compliance of the high-risk AI systems placed on the market or put into
        service in the Union by those providers who are not established in the Union
        and in serving as their contact person established in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-83
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 83
      description: In light of the nature and complexity of the value chain for AI
        systems and in line with the New Legislative Framework, it is essential to
        ensure legal certainty and facilitate the compliance with this Regulation.
        Therefore, it is necessary to clarify the role and the specific obligations
        of relevant operators along the value chain, such as importers and distributors
        who may contribute to the development of AI systems. In certain situations
        those operators could act in more than one role at the same time and should
        therefore fulfil cumulatively all relevant obligations associated with those
        roles. For example, an operator could act as a distributor and an importer
        at the same time.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-84
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 84
      description: To ensure legal certainty, it is necessary to clarify that, under
        certain specific conditions, any distributor, importer, deployer or other
        third-party should be considered to be a provider of a high-risk AI system
        and therefore assume all the relevant obligations. This would be the case
        if that party puts its name or trademark on a high-risk AI system already
        placed on the market or put into service, without prejudice to contractual
        arrangements stipulating that the obligations are allocated otherwise, or
        if that party make a substantial modification to a high-risk AI system that
        has already been placed on the market or has already been put into service
        and in a way that it remains a high-risk AI system in accordance with this
        Regulation, or if it modifies the intended purpose of an AI system, including
        a general-purpose AI system, which has not been classified as high-risk and
        has already been placed on the market or put into service, in a way that the
        AI system becomes a high-risk AI system in accordance with this Regulation.
        Those provisions should apply without prejudice to more specific provisions
        established in certain Union harmonisation legislation based on the New Legislative
        Framework, together with which this Regulation should apply. For example,
        Article 16(2) of Regulation (EU) 2017/745, establishing that certain changes
        should not be considered to be modifications of a device that could affect
        its compliance with the applicable requirements, should continue to apply
        to high-risk AI systems that are medical devices within the meaning of that
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-85
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 85
      description: General-purpose AI systems may be used as high-risk AI systems
        by themselves or be components of other high-risk AI systems. Therefore, due
        to their particular nature and in order to ensure a fair sharing of responsibilities
        along the AI value chain, the providers of such systems should, irrespective
        of whether they may be used as high-risk AI systems as such by other providers
        or as components of high-risk AI systems and unless provided otherwise under
        this Regulation, closely cooperate with the providers of the relevant high-risk
        AI systems to enable their compliance with the relevant obligations under
        this Regulation and with the competent authorities established under this
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-86
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 86
      description: Where, under the conditions laid down in this Regulation, the provider
        that initially placed the AI system on the market or put it into service should
        no longer be considered to be the provider for the purposes of this Regulation,
        and when that provider has not expressly excluded the change of the AI system
        into a high-risk AI system, the former provider should nonetheless closely
        cooperate and make available the necessary information and provide the reasonably
        expected technical access and other assistance that are required for the fulfilment
        of the obligations set out in this Regulation, in particular regarding the
        compliance with the conformity assessment of high-risk AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-87
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 87
      description: In addition, where a high-risk AI system that is a safety component
        of a product which falls within the scope of Union harmonisation legislation
        based on the New Legislative Framework is not placed on the market or put
        into service independently from the product, the product manufacturer defined
        in that legislation should comply with the obligations of the provider established
        in this Regulation and should, in particular, ensure that the AI system embedded
        in the final product complies with the requirements of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-88
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 88
      description: Along the AI value chain multiple parties often supply AI systems,
        tools and services but also components or processes that are incorporated
        by the provider into the AI system with various objectives, including the
        model training, model retraining, model testing and evaluation, integration
        into software, or other aspects of model development. Those parties have an
        important role to play in the value chain towards the provider of the high-risk
        AI system into which their AI systems, tools, services, components or processes
        are integrated, and should provide by written agreement this provider with
        the necessary information, capabilities, technical access and other assistance
        based on the generally acknowledged state of the art, in order to enable the
        provider to fully comply with the obligations set out in this Regulation,
        without compromising their own intellectual property rights or trade secrets.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-89
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 89
      description: Third parties making accessible to the public tools, services,
        processes, or AI components other than general-purpose AI models, shall not
        be mandated to comply with requirements targeting the responsibilities along
        the AI value chain, in particular towards the provider that has used or integrated
        them, when those tools, services, processes, or AI components are made accessible
        under a free and open licence. Developers of free and open-source tools, services,
        processes, or AI components other than general-purpose AI models should be
        encouraged to implement widely adopted documentation practices, such as model
        cards and data sheets, as a way to accelerate information sharing along the
        AI value chain, allowing the promotion of trustworthy AI systems in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-90
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 90
      description: The Commission could develop and recommend voluntary model contractual
        terms between providers of high-risk AI systems and third parties that supply
        tools, services, components or processes that are used or integrated in high-risk
        AI systems, to facilitate the cooperation along the value chain. When developing
        voluntary model contractual terms, the Commission should also take into account
        possible contractual requirements applicable in specific sectors or business
        cases.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-91
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 91
      description: Given the nature of AI systems and the risks to safety and fundamental
        rights possibly associated with their use, including as regards the need to
        ensure proper monitoring of the performance of an AI system in a real-life
        setting, it is appropriate to set specific responsibilities for deployers.
        Deployers should in particular take appropriate technical and organisational
        measures to ensure they use high-risk AI systems in accordance with the instructions
        of use and certain other obligations should be provided for with regard to
        monitoring of the functioning of the AI systems and with regard to record-keeping,
        as appropriate. Furthermore, deployers should ensure that the persons assigned
        to implement the instructions for use and human oversight as set out in this
        Regulation have the necessary competence, in particular an adequate level
        of AI literacy, training and authority to properly fulfil those tasks. These
        obligations should be without prejudice to other deployer obligations in relation
        to high-risk AI systems under Union or national law
    - urn: urn:intuitem:risk:req_node:ai-act:recital-92
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 92
      description: This Regulation is without prejudice to obligations for employers
        to inform or to inform and consult workers or their representatives under
        Union or national law and practice, including Directive 2002/14/EC of the
        European Parliament and of the Council on a general framework for informing
        and consulting employees, on decisions to put into service or use AI systems.
        It remains necessary to ensure information of workers and their representatives
        on the planned deployment of high-risk AI systems at the workplace where the
        conditions for those information or information and consultation obligations
        in other legal instruments are not fulfilled. Moreover, such information right
        is ancillary and necessary to the objective of protecting fundamental rights
        that underlies this Regulation. Therefore, an information requirement to that
        effect should be laid down in this Regulation, without affecting any existing
        rights of workers.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-93
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 93
      description: Whilst risks related to AI systems can result from the way such
        systems are designed, risks can as well stem from how such AI systems are
        used. Deployers of high-risk AI system therefore play a critical role in ensuring
        that fundamental rights are protected, complementing the obligations of the
        provider when developing the AI system. Deployers are best placed to understand
        how the high-risk AI system will be used concretely and can therefore identify
        potential significant risks that were not foreseen in the development phase,
        due to a more precise knowledge of the context of use, the persons or groups
        of persons likely to be affected, including groups of vulnerable persons.
        Deployers of high-risk AI systems listed in an annex to this Regulation also
        play a critical role in informing natural persons and should, when they make
        decisions or assist in making decisions related to natural persons, where
        applicable, inform the natural persons that they are subject to the use of
        the high-risk AI system. This information should include the intended purpose
        and the type of decisions it makes. The deployer should also inform the natural
        person about its right to an explanation provided under this Regulation. With
        regard to high-risk AI systems used for law enforcement purposes, that obligation
        should be implemented in accordance with Article 13 of Directive (EU) 2016/680.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-94
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 94
      description: Any processing of biometric data involved in the use of AI systems
        for biometric identification for the purpose of law enforcement needs to comply
        with Article 10 of Directive (EU) 2016/680, that allows such processing only
        where strictly necessary, subject to appropriate safeguards for the rights
        and freedoms of the data subject, and where authorised by Union or Member
        State law. Such use, when authorized, also needs to respect the principles
        laid down in Article 4 (1) of Directive (EU) 2016/680 including lawfulness,
        fairness and transparency, purpose limitation, accuracy and storage limitation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-95
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 95
      description: Without prejudice to applicable Union law, in particular Regulation
        (EU) 2016/679 and Directive (EU) 2016/680, considering the intrusive nature
        of post remote biometric identification systems, the use of post remote biometric
        identification systems shall be subject to safeguards. Post biometric identification
        systems should always be used in a way that is proportionate, legitimate and
        strictly necessary, and thus targeted, in terms of the individuals to be identified,
        the location, temporal scope and based on a closed data set of legally acquired
        video footage. In any case, post remote biometric identification systems should
        not be used in the framework of law enforcement to lead to indiscriminate
        surveillance. The conditions for post remote biometric identification should
        in any case not provide a basis to circumvent the conditions of the prohibition
        and strict exceptions for real time remote biometric identification.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-96
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 96
      description: "In order to efficiently ensure that fundamental rights are protected,\
        \ deployers of high- risk AI systems that are bodies governed by public law,\
        \ or private operators providing public services and operators deploying certain\
        \ high-risk AI systems listed in an annex to this Regulation, such as banking\
        \ or insurance entities, should carry out a fundamental rights impact assessment\
        \ prior to putting it into use. Services important for individuals that are\
        \ of public nature may also be provided by private entities. Private operators\
        \ providing such services of public nature are linked to tasks in the public\
        \ interest such as in the area of education, healthcare, social services,\
        \ housing, administration of justice. The aim of the fundamental rights impact\
        \ assessment is for the deployer to identify the specific risks to the rights\
        \ of individuals or groups of individuals likely to be affected, identify\
        \ measures to be taken in the case of a materialisation of those risk. The\
        \ impact assessment should apply to the first use of the high-risk AI system,\
        \ and should be updated when the deployer considers that any of the relevant\
        \ factors have changed. The impact assessment should identify the deployer\u2019\
        s relevant processes in which the high-risk AI system will be used in line\
        \ with its intended purpose, and should include a description of the period\
        \ of time and frequency in which the system is intended to be used as well\
        \ as of specific categories of natural persons and groups who are likely to\
        \ be affected in the specific context of use.\nThe assessment should also\
        \ include the identification of specific risks of harm likely to have an impact\
        \ on the fundamental rights of those persons or groups. While performing this\
        \ assessment, the deployer should take into account information relevant to\
        \ a proper assessment of the impact, including but not limited to the information\
        \ given by the provider of the high-risk AI system in the instructions for\
        \ use. In light of the risks identified, deployers should determine measures\
        \ to be taken in the case of a materialisation of those risks, including for\
        \ example governance arrangements in that specific context of use, such as\
        \ arrangements for human oversight according to the instructions of use or,\
        \ complaint handling and redress procedures, as they could be instrumental\
        \ in mitigating risks to fundamental rights in concrete use-cases. After performing\
        \ that impact assessment, the deployer should notify the relevant market surveillance\
        \ authority. Where appropriate, to collect relevant information necessary\
        \ to perform the impact assessment, deployers of high-risk AI system, in particular\
        \ when AI systems are used in the public sector, could involve relevant stakeholders,\
        \ including the representatives of groups of persons likely to be affected\
        \ by the AI system, independent experts, and civil society organisations in\
        \ conducting such impact assessments and designing measures to be taken in\
        \ the case of materialisation of the risks. The European Artificial Intelligence\
        \ Office (\u2018AI Office\u2019) should develop a template for a questionnaire\
        \ in order to facilitate compliance and reduce the administrative burden for\
        \ deployers."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-97
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 97
      description: 'The notion of general-purpose AI models should be clearly defined
        and set apart from the notion of AI systems to enable legal certainty. The
        definition should be based on the key functional characteristics of a general-purpose
        AI model, in particular the generality and the capability to competently perform
        a wide range of distinct tasks. These models are typically trained on large
        amounts of data, through various methods, such as self- supervised, unsupervised
        or reinforcement learning. General-purpose AI models may be placed on the
        market in various ways, including through libraries, application programming
        interfaces (APIs), as direct download, or as physical copy. These models may
        be further modified or fine-tuned into new models. Although AI models are
        essential components of AI systems, they do not constitute AI systems on their
        own. AI models require the addition of further components, such as for example
        a user interface, to become AI systems. AI models are typically integrated
        into and form part of AI systems. This Regulation provides specific rules
        for general-purpose AI models and for general-purpose AI models that pose
        systemic risks, which should apply also when these models are integrated or
        form part of an AI system. It should be understood that the obligations for
        the providers of general-purpose AI models should apply once the general-purpose
        AI models are placed on the market.

        When the provider of a general-purpose AI model integrates an own model into
        its own AI system that is made available on the market or put into service,
        that model should be considered to be placed on the market and, therefore,
        the obligations in this Regulation for models should continue to apply in
        addition to those for AI systems. The obligations laid down for models should
        in any case not apply when an own model is used for purely internal processes
        that are not essential for providing a product or a service to third parties
        and the rights of natural persons are not affected. Considering their potential
        significantly negative effects, the general-purpose AI models with systemic
        risk should always be subject to the relevant obligations under this Regulation.
        The definition should not cover AI models used before their placing on the
        market for the sole purpose of research, development and prototyping activities.
        This is without prejudice to the obligation to comply with this Regulation
        when, following such activities, a model is placed on the market.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-98
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 98
      description: Whereas the generality of a model could, among other criteria,
        also be determined by a number of parameters, models with at least a billion
        of parameters and trained with a large amount of data using self-supervision
        at scale should be considered to display significant generality and to competently
        perform a wide range of distinctive tasks.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-99
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 99
      description: Large generative AI models are a typical example for a general-purpose
        AI model, given that they allow for flexible generation of content, such as
        in the form of text, audio, images or video, that can readily accommodate
        a wide range of distinctive tasks.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-100
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 100
      description: When a general-purpose AI model is integrated into or forms part
        of an AI system, this system should be considered to be general-purpose AI
        system when, due to this integration, this system has the capability to serve
        a variety of purposes. A general- purpose AI system can be used directly,
        or it may be integrated into other AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-101
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 101
      description: Providers of general-purpose AI models have a particular role and
        responsibility along the AI value chain, as the models they provide may form
        the basis for a range of downstream systems, often provided by downstream
        providers that necessitate a good understanding of the models and their capabilities,
        both to enable the integration of such models into their products, and to
        fulfil their obligations under this or other regulations. Therefore, proportionate
        transparency measures should be laid down, including the drawing up and keeping
        up to date of documentation, and the provision of information on the general-purpose
        AI model for its usage by the downstream providers. Technical documentation
        should be prepared and kept up to date by the general-purpose AI model provider
        for the purpose of making it available, upon request, to the AI Office and
        the national competent authorities. The minimal set of elements to be included
        in such documentation should be set out in annexes to this Regulation. The
        Commission should be empowered to amend those annexes by means of delegated
        acts in the light of evolving technological developments.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-102
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 102
      description: Software and data, including models, released under a free and
        open-source licence that allows them to be openly shared and where users can
        freely access, use, modify and redistribute them or modified versions thereof,
        can contribute to research and innovation in the market and can provide significant
        growth opportunities for the Union economy. General-purpose AI models released
        under free and open-source licences should be considered to ensure high levels
        of transparency and openness if their parameters, including the weights, the
        information on the model architecture, and the information on model usage
        are made publicly available. The licence should be considered to be free and
        open-source also when it allows users to run, copy, distribute, study, change
        and improve software and data, including models under the condition that the
        original provider of the model is credited, the identical or comparable terms
        of distribution are respected.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-103
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 103
      description: Free and open-source AI components covers the software and data,
        including models and general-purpose AI models, tools, services or processes
        of an AI system. Free and open-source AI components can be provided through
        different channels, including their development on open repositories. For
        the purposes of this Regulation, AI components that are provided against a
        price or otherwise monetised, including through the provision of technical
        support or other services, including through a software platform, related
        to the AI component, or the use of personal data for reasons other than exclusively
        for improving the security, compatibility or interoperability of the software,
        with the exception of transactions between microenterprises, should not benefit
        from the exceptions provided to free and open source AI components. The fact
        of making AI components available through open repositories should not, in
        itself, constitute a monetisation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-104
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 104
      description: The providers of general-purpose AI models that are released under
        a free and open source license, and whose parameters, including the weights,
        the information on the model architecture, and the information on model usage,
        are made publicly available should be subject to exceptions as regards the
        transparency-related requirements imposed on general-purpose AI models, unless
        they can be considered to present a systemic risk, in which case the circumstance
        that the model is transparent and accompanied by an open source license should
        not be considered to be a sufficient reason to exclude compliance with the
        obligations under this Regulation. In any case, given that the release of
        general-purpose AI models under free and open source licence does not necessarily
        reveal substantial information on the data set used for the training or fine-tuning
        of the model and on how compliance of copyright law was thereby ensured, the
        exception provided for general-purpose AI models from compliance with the
        transparency-related requirements should not concern the obligation to produce
        a summary about the content used for model training and the obligation to
        put in place a policy to comply with Union copyright law, in particular to
        identify and comply with the reservation of rights pursuant to Article 4(3)
        of Directive (EU) 2019/790 of the European Parliament and of the Council.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-105
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 105
      description: General-purpose models, in particular large generative models,
        capable of generating text, images, and other content, present unique innovation
        opportunities but also challenges to artists, authors, and other creators
        and the way their creative content is created, distributed, used and consumed.
        The development and training of such models require access to vast amounts
        of text, images, videos, and other data. Text and data mining techniques may
        be used extensively in this context for the retrieval and analysis of such
        content, which may be protected by copyright and related rights. Any use of
        copyright protected content requires the authorisation of the rightsholder
        concerned unless relevant copyright exceptions and limitations apply. Directive
        (EU) 2019/790 introduced exceptions and limitations allowing reproductions
        and extractions of works or other subject matter, for the purpose of text
        and data mining, under certain conditions. Under these rules, rightsholders
        may choose to reserve their rights over their works or other subject matter
        to prevent text and data mining, unless this is done for the purposes of scientific
        research. Where the rights to opt out has been expressly reserved in an appropriate
        manner, providers of general-purpose AI models need to obtain an authorisation
        from rightsholders if they want to carry out text and data mining over such
        works.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-106
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 106
      description: Providers that place general-purpose AI models on the Union market
        should ensure compliance with the relevant obligations in this Regulation.
        To that end, providers of general-purpose AI models should put in place a
        policy to comply with Union law on copyright and related rights, in particular
        to identify and comply with the reservations of rights expressed by rightsholders
        pursuant to Article 4(3) of Directive (EU) 2019/790. Any provider placing
        a general-purpose AI model on the Union market should comply with this obligation,
        regardless of the jurisdiction in which the copyright-relevant acts underpinning
        the training of those general-purpose AI models take place. This is necessary
        to ensure a level playing field among providers of general-purpose AI models
        where no provider should be able to gain a competitive advantage in the Union
        market by applying lower copyright standards than those provided in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-107
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 107
      description: In order to increase transparency on the data that is used in the
        pre-training and training of general-purpose AI models, including text and
        data protected by copyright law, it is adequate that providers of such models
        draw up and make publicly available a sufficiently detailed summary of the
        content used for training the general-purpose model. While taking into due
        account the need to protect trade secrets and confidential business information,
        this summary should be generally comprehensive in its scope instead of technically
        detailed to facilitate parties with legitimate interests, including copyright
        holders, to exercise and enforce their rights under Union law, for example
        by listing the main data collections or sets that went into training the model,
        such as large private or public databases or data archives, and by providing
        a narrative explanation about other data sources used. It is appropriate for
        the AI Office to provide a template for the summary, which should be simple,
        effective, and allow the provider to provide the required summary in narrative
        form.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-108
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 108
      description: With regard to the obligations imposed on providers of general-purpose
        AI models to put in place a policy to comply with Union copyright law and
        make publicly available a summary of the content used for the training, the
        AI Office should monitor whether the provider has fulfilled those obligations
        without verifying or proceeding to a work-by- work assessment of the training
        data in terms of copyright compliance. This Regulation does not affect the
        enforcement of copyright rules as provided for under Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-109
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 109
      description: Compliance with the obligations applicable to the providers of
        general-purpose AI models should be commensurate and proportionate to the
        type of model provider, excluding the need for compliance for persons who
        develop or use models for non- professional or scientific research purposes,
        who should nevertheless be encouraged to voluntarily comply with these requirements.
        Without prejudice to Union copyright law, compliance with these obligations
        should take due account of the size of the provider and allow simplified ways
        of compliance for SMEs, including start-ups, that should not represent an
        excessive cost and not discourage the use of such models. In the case of a
        modification or fine-tuning of a model, the obligations for providers should
        be limited to that modification or fine-tuning, for example by complementing
        the already existing technical documentation with information on the modifications,
        including new training data sources, as a means to comply with the value chain
        obligations provided in this Regulation
    - urn: urn:intuitem:risk:req_node:ai-act:recital-110
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 110
      description: "General-purpose AI models could pose systemic risks which include,\
        \ but are not limited to, any actual or reasonably foreseeable negative effects\
        \ in relation to major accidents, disruptions of critical sectors and serious\
        \ consequences to public health and safety; any actual or reasonably foreseeable\
        \ negative effects on democratic processes, public and economic security;\
        \ the dissemination of illegal, false, or discriminatory content. Systemic\
        \ risks should be understood to increase with model capabilities and model\
        \ reach, can arise along the entire lifecycle of the model, and are influenced\
        \ by conditions of misuse, model reliability, model fairness and model security,\
        \ the degree of autonomy of the model, its access to tools, novel or combined\
        \ modalities, release and distribution strategies, the potential to remove\
        \ guardrails and other factors. In particular, international approaches have\
        \ so far identified the need to devote attention to risks from potential intentional\
        \ misuse or unintended issues of control relating to alignment with human\
        \ intent; chemical, biological, radiological, and nuclear risks, such as the\
        \ ways in which barriers to entry can be lowered, including for weapons development,\
        \ design acquisition, or use; offensive cyber capabilities, such as the ways\
        \ in vulnerability discovery, exploitation, or operational use can be enabled;\
        \ the effects of interaction and tool use, including for example the capacity\
        \ to control physical systems and interfere with critical infrastructure;\
        \ risks from models of making copies of themselves or \u2018self- replicating\u2019\
        \ or training other models; the ways in which models can give rise to harmful\
        \ bias and discrimination with risks to individuals, communities or societies;\
        \ the facilitation of disinformation or harming privacy with threats to democratic\
        \ values and human rights; risk that a particular event could lead to a chain\
        \ reaction with considerable negative effects that could affect up to an entire\
        \ city, an entire domain activity or an entire community."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-111
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 111
      description: "It is appropriate to establish a methodology for the classification\
        \ of general-purpose AI models as general-purpose AI model with systemic risks.\
        \ Since systemic risks result from particularly high capabilities, a general-purpose\
        \ AI model should be considered to present systemic risks if it has high-impact\
        \ capabilities, evaluated on the basis of appropriate technical tools and\
        \ methodologies, or significant impact on the internal market due to its reach.\
        \ High-impact capabilities in general-purpose AI models means capabilities\
        \ that match or exceed the capabilities recorded in the most advanced general-\
        \ purpose AI models. The full range of capabilities in a model could be better\
        \ understood after its release on the market or when users interact with the\
        \ model. According to the state of the art at the time of entry into force\
        \ of this Regulation, the cumulative amount of compute used for the training\
        \ of the general-purpose AI model measured in floating point operations (\u2018\
        FLOPs\u2019) is one of the relevant approximations for model capabilities.\
        \ The amount of compute used for training cumulates the compute used across\
        \ the activities and methods that are intended to enhance the capabilities\
        \ of the model prior to deployment, such as pre-training, synthetic data generation\
        \ and fine-tuning. Therefore, an initial threshold of FLOPs should be set,\
        \ which, if met by a general-purpose AI model, leads to a presumption that\
        \ the model is a general-purpose AI model with systemic risks. This threshold\
        \ should be adjusted over time to reflect technological and industrial changes,\
        \ such as algorithmic improvements or increased hardware efficiency, and should\
        \ be supplemented with benchmarks and indicators for model capability.\nTo\
        \ inform this, the AI Office should engage with the scientific community,\
        \ industry, civil society and other experts. Thresholds, as well as tools\
        \ and benchmarks for the assessment of high-impact capabilities, should be\
        \ strong predictors of generality, its capabilities and associated systemic\
        \ risk of general-purpose AI models, and could take into taking into account\
        \ the way the model will be placed on the market or the number of users it\
        \ may affect. To complement this system, there should be a possibility for\
        \ the Commission to take individual decisions designating a general-purpose\
        \ AI model as a general-purpose AI model with systemic risk if it is found\
        \ that such model has capabilities or an impact equivalent to those captured\
        \ by the set threshold. That decision should be taken on the basis of an overall\
        \ assessment of the criteria for the designation of general-purpose AI models\
        \ with systemic risk set out in an annex to this Regulation, such as quality\
        \ or size of the training data set, number of business and end users, its\
        \ input and output modalities, its degree of autonomy and scalability, or\
        \ the tools it has access to. Upon a reasoned request of a provider whose\
        \ model has been designated as a general-purpose AI model with systemic risk,\
        \ the Commission should take the request into account and may decide to reassess\
        \ whether the general-purpose AI model can still be considered to present\
        \ systemic risks."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-112
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 112
      description: It is also necessary to clarify a procedure for the classification
        of a general-purpose AI model with systemic risks. A general-purpose AI model
        that meets the applicable threshold for high-impact capabilities should be
        presumed to be a general-purpose AI models with systemic risk. The provider
        should notify the AI Office at the latest two weeks after the requirements
        are met or it becomes known that a general-purpose AI model will meet the
        requirements that lead to the presumption. This is especially relevant in
        relation to the FLOP threshold because training of general-purpose AI models
        takes considerable planning which includes the upfront allocation of compute
        resources and, therefore, providers of general-purpose AI models are able
        to know if their model would meet the threshold before the training is completed.
        In the context of that notification, the provider should be able to demonstrate
        that, because of its specific characteristics, a general-purpose AI model
        exceptionally does not present systemic risks, and that it thus should not
        be classified as a general-purpose AI model with systemic risks. That information
        is valuable for the AI Office to anticipate the placing on the market of general-purpose
        AI models with systemic risks and the providers can start to engage with the
        AI Office early on. That information is especially important with regard to
        general- purpose AI models that are planned to be released as open-source,
        given that, after open-source model release, necessary measures to ensure
        compliance with the obligations under this Regulation may be more difficult
        to implement.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-113
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 113
      description: If the Commission becomes aware of the fact that a general-purpose
        AI model meets the requirements to classify as a general-purpose model with
        systemic risk, which previously had either not been known or of which the
        relevant provider has failed to notify the Commission, the Commission should
        be empowered to designate it so. A system of qualified alerts should ensure
        that the AI Office is made aware by the scientific panel of general-purpose
        AI models that should possibly be classified as general-purpose AI models
        with systemic risk, in addition to the monitoring activities of the AI Office.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-114
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 114
      description: "The providers of general-purpose AI models presenting systemic\
        \ risks should be subject, in addition to the obligations provided for providers\
        \ of general-purpose AI models, to obligations aimed at identifying and mitigating\
        \ those risks and ensuring an adequate level of cybersecurity protection,\
        \ regardless of whether it is provided as a standalone model or embedded in\
        \ an AI system or a product. To achieve those objectives, this Regulation\
        \ should require providers to perform the necessary model evaluations, in\
        \ particular prior to its first placing on the market, including conducting\
        \ and documenting adversarial testing of models, also, as appropriate, through\
        \ internal or independent external testing. In addition, providers of general-purpose\
        \ AI models with systemic risks should continuously assess and mitigate systemic\
        \ risks, including for example by putting in place risk-management policies,\
        \ such as accountability and governance processes, implementing post-market\
        \ monitoring, taking appropriate measures along the entire model\u2019s lifecycle\
        \ and cooperating with relevant actors along the AI value chain."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-115
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 115
      description: Providers of general-purpose AI models with systemic risks should
        assess and mitigate possible systemic risks. If, despite efforts to identify
        and prevent risks related to a general-purpose AI model that may present systemic
        risks, the development or use of the model causes a serious incident, the
        general-purpose AI model provider should without undue delay keep track of
        the incident and report any relevant information and possible corrective measures
        to the Commission and national competent authorities. Furthermore, providers
        should ensure an adequate level of cybersecurity protection for the model
        and its physical infrastructure, if appropriate, along the entire model lifecycle.
        Cybersecurity protection related to systemic risks associated with malicious
        use of or attacks should duly consider accidental model leakage, unauthorised
        releases, circumvention of safety measures, and defence against cyberattacks,
        unauthorised access or model theft. That protection could be facilitated by
        securing model weights, algorithms, servers, and data sets, such as through
        operational security measures for information security, specific cybersecurity
        policies, adequate technical and established solutions, and cyber and physical
        access controls, appropriate to the relevant circumstances and the risks involved.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-116
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 116
      description: The AI Office should encourage and facilitate the drawing up, review
        and adaptation of codes of practice, taking into account international approaches.
        All providers of general- purpose AI models could be invited to participate.
        To ensure that the codes of practice reflect the state of the art and duly
        take into account a diverse set of perspectives, the AI Office should collaborate
        with relevant national competent authorities, and could, where appropriate,
        consult with civil society organisations and other relevant stakeholders and
        experts, including the Scientific Panel, for the drawing up of such codes.
        Codes of practice should cover obligations for providers of general-purpose
        AI models and of general-purpose models presenting systemic risks. In addition,
        as regards systemic risks, codes of practice should help to establish a risk
        taxonomy of the type and nature of the systemic risks at Union level, including
        their sources. Codes of practice should also be focused on specific risk assessment
        and mitigation measures.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-117
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 117
      description: The codes of practice should represent a central tool for the proper
        compliance with the obligations provided for under this Regulation for providers
        of general-purpose AI models. Providers should be able to rely on codes of
        practice to demonstrate compliance with the obligations. By means of implementing
        acts, the Commission may decide to approve a code of practice and give it
        a general validity within the Union, or, alternatively, to provide common
        rules for the implementation of the relevant obligations, if, by the time
        this Regulation becomes applicable, a code of practice cannot be finalised
        or is not deemed adequate by the AI Office. Once a harmonised standard is
        published and assessed as suitable to cover the relevant obligations by the
        AI Office, the compliance with a European harmonised standard should grant
        providers the presumption of conformity. Providers of general-purpose AI models
        should furthermore be able to demonstrate compliance using alternative adequate
        means, if codes of practice or harmonized standards are not available, or
        they choose not to rely on those.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-118
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 118
      description: This Regulation regulates AI systems and models by imposing certain
        requirements and obligations for relevant market actors that are placing them
        on the market, putting into service or use in the Union, thereby complementing
        obligations for providers of intermediary services that embed such systems
        or models into their services regulated by Regulation (EU) 2022/2065 of the
        European Parliament and of the Council. To the extent that such systems or
        models are embedded into designated very large online platforms or very large
        online search engines, they are subject to the risk-management framework provided
        for in Regulation (EU) 2022/2065. Consequently, the corresponding obligations
        of this Regulation should be presumed to be fulfilled, unless significant
        systemic risks not covered by Regulation (EU) 2022/2065 emerge and are identified
        in such models. Within this framework, providers of very large online platforms
        and very large online search engines are obliged to assess potential systemic
        risks stemming from the design, functioning and use of their services, including
        how the design of algorithmic systems used in the service may contribute to
        such risks, as well as systemic risks stemming from potential misuses. Those
        providers are also obliged to take appropriate mitigating measures in observance
        of fundamental rights.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-119
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 119
      description: Considering the quick pace of innovation and the technological
        evolution of digital services in scope of different instruments of Union law
        in particular having in mind the usage and the perception of their recipients,
        the AI systems subject to this Regulation may be provided as intermediary
        services or parts thereof within the meaning of Regulation (EU) 2022/2065,
        which should be interpreted in a technology-neutral manner. For example, AI
        systems may be used to provide online search engines, in particular, to the
        extent that an AI system such as an online chatbot performs searches of, in
        principle, all websites, then incorporates the results into its existing knowledge
        and uses the updated knowledge to generate a single output that combines different
        sources of information.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-120
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 120
      description: Furthermore, obligations placed on providers and deployers of certain
        AI systems in this Regulation to enable the detection and disclosure that
        the outputs of those systems are artificially generated or manipulated are
        particularly relevant to facilitate the effective implementation of Regulation
        (EU) 2022/2065. This applies in particular as regards the obligations of providers
        of very large online platforms or very large online search engines to identify
        and mitigate systemic risks that may arise from the dissemination of content
        that has been artificially generated or manipulated, in particular risk of
        the actual or foreseeable negative effects on democratic processes, civic
        discourse and electoral processes, including through disinformation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-121
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 121
      description: "Standardisation should play a key role to provide technical solutions\
        \ to providers to ensure compliance with this Regulation, in line with the\
        \ state of the art, to promote innovation as well as competitiveness and growth\
        \ in the single market. Compliance with harmonised standards as defined in\
        \ Article 2, point (1)(c), of Regulation (EU) No 1025/2012 of the European\
        \ Parliament and of the Council, which are normally expected to reflect the\
        \ state of the art, should be a means for providers to demonstrate conformity\
        \ with the requirements of this Regulation. A balanced representation of interests\
        \ involving all relevant stakeholders in the development of standards, in\
        \ particular SMEs, consumer organisations and environmental and social stakeholders\
        \ in accordance with Articles 5 and 6 of Regulation (EU) No 1025/2012 should\
        \ therefore be encouraged. In order to facilitate compliance, the standardisation\
        \ requests should be issued by the Commission without undue delay. When preparing\
        \ the standardisation request, the Commission should consult the advisory\
        \ forum and the Board in order to collect relevant expertise. However, In\
        \ the absence of relevant references to harmonised standards, the Commission\
        \ should be able to establish, via implementing acts, and after consultation\
        \ of the advisory forum, common specifications for certain requirements under\
        \ this Regulation.\nThe common specification should be an exceptional fall\
        \ back solution to facilitate the provider\u2019s obligation to comply with\
        \ the requirements of this Regulation, when the standardisation request has\
        \ not been accepted by any of the European standardisation organisations,\
        \ or when the relevant harmonized standards insufficiently address fundamental\
        \ rights concerns, or when the harmonised standards do not comply with the\
        \ request, or when there are delays in the adoption of an appropriate harmonised\
        \ standard. Where such a delay in the adoption of a harmonised standard is\
        \ due to the technical complexity of that standard, this should be considered\
        \ by the Commission before contemplating the establishment of common specifications.\
        \ When developing common specifications, the Commission is encouraged to cooperate\
        \ with international partners and international standardisation bodies."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-122
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 122
      description: It is appropriate that, without prejudice to the use of harmonised
        standards and common specifications, providers of high-risk AI system that
        has been trained and tested on data reflecting the specific geographical,
        behavioural, contextual or functional setting within which the AI system is
        intended to be used, should be presumed to comply with the relevant measure
        provided for under the requirement on data governance set out in this Regulation.
        Without prejudice to the requirements related to robustness and accuracy set
        out in this Regulation, in accordance with Article 54(3) of Regulation (EU)
        2019/881 of the European Parliament and of the Council, high-risk AI systems
        that have been certified or for which a statement of conformity has been issued
        under a cybersecurity scheme pursuant to that Regulation and the references
        of which have been published in the Official Journal of the European Union
        should be presumed to comply with the cybersecurity requirement of this Regulation
        in so far as the cybersecurity certificate or statement of conformity or parts
        thereof cover the cybersecurity requirement of this Regulation This remains
        without prejudice to the voluntary nature of that cybersecurity scheme.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-123
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 123
      description: In order to ensure a high level of trustworthiness of high-risk
        AI systems, those systems should be subject to a conformity assessment prior
        to their placing on the market or putting into service.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-124
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 124
      description: It is appropriate that, in order to minimise the burden on operators
        and avoid any possible duplication, for high-risk AI systems related to products
        which are covered by existing Union harmonisation legislation based on the
        New Legislative Framework, the compliance of those AI systems with the requirements
        of this Regulation should be assessed as part of the conformity assessment
        already provided for in that law. The applicability of the requirements of
        this Regulation should thus not affect the specific logic, methodology or
        general structure of conformity assessment under the relevant Union harmonisation
        legislation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-125
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 125
      description: Given the complexity of high-risk AI systems and the risks that
        are associated to them, it is important to develop an adequate system of conformity
        assessment procedure for high- risk AI systems involving notified bodies,
        so called third party conformity assessment. However, given the current experience
        of professional pre-market certifiers in the field of product safety and the
        different nature of risks involved, it is appropriate to limit, at least in
        an initial phase of application of this Regulation, the scope of application
        of third-party conformity assessment for high-risk AI systems other than those
        related to products. Therefore, the conformity assessment of such systems
        should be carried out as a general rule by the provider under its own responsibility,
        with the only exception of AI systems intended to be used for biometrics.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-126
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 126
      description: In order to carry out third-party conformity assessments when so
        required, notified bodies should be notified under this Regulation by the
        national competent authorities, provided that they comply with a set of requirements,
        in particular on independence, competence, absence of conflicts of interests
        and suitable cybersecurity requirements. Notification of those bodies should
        be sent by national competent authorities to the Commission and the other
        Member States by means of the electronic notification tool developed and managed
        by the Commission pursuant to Article R23 of Annex I to Decision No 768/2008/EC.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-127
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 127
      description: In line with Union commitments under the World Trade Organization
        Agreement on Technical Barriers to Trade, it is adequate to facilitate the
        mutual recognition of conformity assessment results produced by competent
        conformity assessment bodies, independent of the territory in which they are
        established, provided that those conformity assessment bodies established
        under the law of a third country meet the applicable requirements of this
        Regulation and the Union has concluded an agreement to that extent. In this
        context, the Commission should actively explore possible international instruments
        for that purpose and in particular pursue the conclusion of mutual recognition
        agreements with third countries.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-128
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 128
      description: "In line with the commonly established notion of substantial modification\
        \ for products regulated by Union harmonisation legislation, it is appropriate\
        \ that  whenever a change occurs which may affect the compliance of a high-risk\
        \ AI system with this Regulation (e.g. change of operating system or software\
        \ architecture), or when the intended purpose of the system changes, that\
        \ AI system should be considered to be a new AI system which should undergo\
        \ a new conformity assessment. However, changes occurring to the algorithm\
        \ and the performance of AI systems which continue to \u2018learn\u2019 after\
        \ being placed on the market or put into service, namely  automatically adapting\
        \ how functions are carried out, should not constitute a substantial modification,\
        \ provided that those changes have been pre-determined by the provider and\
        \ assessed at the moment of the conformity assessment."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-129
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 129
      description: High-risk AI systems should bear the CE marking to indicate their
        conformity with this Regulation so that they can move freely within the internal
        market. For high-risk AI systems embedded in a product, a physical CE marking
        should be affixed, and may be complemented by a digital CE marking. For high-risk
        AI systems only provided digitally, a digital CE marking should be used. Member
        States should not create unjustified obstacles to the placing on the market
        or the putting into service of high-risk AI systems that comply with the requirements
        laid down in this Regulation and bear the CE marking.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-130
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 130
      description: Under certain conditions, rapid availability of innovative technologies
        may be crucial for health and safety of persons, the protection of the environment
        and climate change and for society as a whole. It is thus appropriate that
        under exceptional reasons of public security or protection of life and health
        of natural persons, environmental protection and the protection of key industrial
        and infrastructural assets, market surveillance authorities could authorise
        the placing on the market or the putting into service of AI systems which
        have not undergone a conformity assessment. In a duly justified situations
        as provided under this Regulation, law enforcement authorities or civil protection
        authorities may put a specific high-risk AI system into service without the
        authorisation of the market surveillance authority, provided that such authorisation
        is requested during or after the use without undue delay.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-131
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 131
      description: 'In order to facilitate the work of the Commission and the Member
        States in the AI field as well as to increase the transparency towards the
        public, providers of high-risk AI systems other than those related to products
        falling within the scope of relevant existing Union harmonisation legislation,
        as well as providers who consider that the high-risk AI system listed in an
        annex to this Regulation is not high-risk on the basis of a derogation, should
        be required to register themselves and information about their AI system in
        a EU database, to be established and managed by the Commission. Before using
        such a high- risk AI system, deployers of high-risk AI systems that are public
        authorities, agencies or bodies, should register themselves in such database
        and select the system that they envisage to use.

        Other deployers should be entitled to do so voluntarily. This section of the
        database should be publicly accessible, free of charge, the information should
        be easily navigable, understandable and machine-readable. The database should
        also be user-friendly, for example by providing search functionalities, including
        through keywords, allowing the general public to find relevant information
        to be submitted upon the registration of high- risk AI systems and on the
        high-risk AI systems, set out in annexes to this Regulation, to which the
        high-risk AI systems correspond. Any substantial modification of high-risk
        AI systems should also be registered in the EU database. For high-risk AI
        systems in the area of law enforcement, migration, asylum and border control
        management, the registration obligations should be fulfilled in a secure non-public
        section of the database. Access to the secure non-public section should be
        strictly limited to the Commission as well as to market surveillance authorities
        with regard to their national section of that database. High-risk AI systems
        in the area of critical infrastructure should only be registered at national
        level. The Commission should be the controller of the EU database, in accordance
        with Regulation (EU) 2018/1725. In order to ensure the full functionality
        of the database, when deployed, the procedure for setting the database should
        include the elaboration of functional specifications by the Commission and
        an independent audit report. The Commission should take into account cybersecurity
        and hazard-related risks when carrying out its tasks as data controller on
        the EU database. In order to maximise the availability and use of the database
        by the public, the database, including the information made available through
        it, should comply with requirements under the Directive (EU) 2019/882.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-132
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 132
      description: Certain AI systems intended to interact with natural persons or
        to generate content may pose specific risks of impersonation or deception
        irrespective of whether they qualify as high-risk or not. In certain circumstances,
        the use of these systems should therefore be subject to specific transparency
        obligations without prejudice to the requirements and obligations for high-risk
        AI systems and subject to targeted exceptions to take into account the special
        need of law enforcement. In particular, natural persons should be notified
        that they are interacting with an AI system, unless this is obvious from the
        point of view of a natural person who is reasonably well-informed, observant
        and circumspect taking into account the circumstances and the context of use.
        When implementing such obligation, the characteristics of individuals belonging
        to groups of vulnerable persons due to their age or disability should be taken
        into account to the extent the AI system is intended to interact with those
        groups as well. Moreover, natural persons should be notified when they are
        exposed to systems that, by processing their biometric data, can identify
        or infer the emotions or intentions of those persons or assign them to specific
        categories. Such specific categories can relate to aspects such as sex, age,
        hair colour, eye colour, tattoos, personal traits, ethnic origin, personal
        preferences and interests. Such information and notifications should be provided
        in accessible formats for persons with disabilities.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-133
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 133
      description: A variety of AI systems can generate large quantities of synthetic
        content that becomes increasingly hard for humans to distinguish from human-generated
        and authentic content. The wide availability and increasing capabilities of
        those systems have a significant impact on the integrity and trust in the
        information ecosystem, raising new risks of misinformation and manipulation
        at scale, fraud, impersonation and consumer deception. In light of those impacts,
        the fast technological pace and the need for new methods and techniques to
        trace origin of information, it is appropriate to require providers of those
        systems to embed technical solutions that enable marking in a machine readable
        format and detection that the output has been generated or manipulated by
        an AI system and not a human. Such techniques and methods should be sufficiently
        reliable, interoperable, effective and robust as far as this is technically
        feasible, taking into account available techniques or a combination of such
        techniques, such as watermarks, metadata identifications, cryptographic methods
        for proving provenance and authenticity of content, logging methods, fingerprints
        or other techniques, as may be appropriate. When implementing this obligation,
        providers should also take into account the specificities and the limitations
        of the different types of content and the relevant technological and market
        developments in the field, as reflected in the generally acknowledged state-of-the-art.
        Such techniques and methods can be implemented at the level of the system
        or at the level of the model, including general- purpose AI models generating
        content, thereby facilitating fulfilment of this obligation by the downstream
        provider of the AI system. To remain proportionate, it is appropriate to envisage
        that this marking obligation should not cover AI systems performing primarily
        an assistive function for standard editing or AI systems not substantially
        altering the input data provided by the deployer or the semantics thereof.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-134
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 134
      description: Further to the technical solutions employed by the providers of
        the system, deployers, who use an AI system to generate or manipulate image,
        audio or video content that appreciably resembles existing persons, places
        or events and would falsely appear to a person to be authentic (deep fakes),
        should also clearly and distinguishably disclose that the content has been
        artificially created or manipulated by labelling the artificial intelligence
        output accordingly and disclosing its artificial origin The compliance with
        this transparency obligation should not be interpreted as indicating that
        the use of the system or its output impedes the right to freedom of expression
        and the right to freedom of the arts and sciences guaranteed in the Charter,
        in particular where the content is part of an evidently creative, satirical,
        artistic or fictional work or programme, subject to appropriate safeguards
        for the rights and freedoms of third parties. In those cases, the transparency
        obligation for deep fakes set out in this Regulation is limited to disclosure
        of the existence of such generated or manipulated content in an appropriate
        manner that does not hamper the display or enjoyment of the work, including
        its normal exploitation and use, while maintaining the utility and quality
        of the work. In addition, it is also appropriate to envisage a similar disclosure
        obligation in relation to AI-generated or manipulated text to the extent it
        is published with the purpose of informing the public on matters of public
        interest unless the AI-generated content has undergone a process of human
        review or editorial control and a natural or legal person holds editorial
        responsibility for the publication of the content.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-135
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 135
      description: To ensure consistent implementation, it is appropriate to empower
        the Commission to adopt implementing acts on the application of the provisions
        on the labelling and detection of artificially generated or manipulated content.
        Without prejudice to the mandatory nature and full applicability of the transparency
        obligations, the Commission may also encourage and facilitate the drawing
        up of codes of practice at Union level to facilitate the effective implementation
        of the obligations regarding the detection and labelling of artificially generated
        or manipulated content, including to support practical arrangements for making,
        as appropriate, the detection mechanisms accessible and facilitating cooperation
        with other actors along the value chain, disseminating content or checking
        its authenticity and provenance to enable the public to effectively distinguish
        AI-generated content.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-136
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 136
      description: The obligations placed on providers and deployers of certain AI
        systems in this Regulation to enable the detection and disclosure that the
        outputs of those systems are artificially generated or manipulated are particularly
        relevant to facilitate the effective implementation of Regulation (EU) 2022/2065.
        This applies in particular as regards the obligations of providers of very
        large online platforms or very large online search engines to identify and
        mitigate systemic risks that may arise from the dissemination of content that
        has been artificially generated or manipulated, in particular risk of the
        actual or foreseeable negative effects on democratic processes, civic discourse
        and electoral processes, including through disinformation. The requirement
        to label content generated by AI systems under this Regulation is without
        prejudice to the obligation in Article 16(6) of Regulation (EU) 2022/2065
        for providers of hosting services to process notices on illegal content received
        pursuant to Article 16(1) of that Regulation and should not influence the
        assessment and the decision on the illegality of the specific content. That
        assessment should be performed solely with reference to the rules governing
        the legality of the content.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-137
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 137
      description: The compliance with the transparency obligations for the AI systems
        coved by this Regulation should not be interpreted as indicating that the
        use of the system or its output is lawful under this Regulation or other Union
        and Member State law and should be without prejudice to other transparency
        obligations for deployers of AI systems laid down in Union or national law.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-138
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 138
      description: "AI is a rapidly developing family of technologies that requires\
        \ regulatory oversight and a safe and controlled space for experimentation,\
        \ while ensuring responsible innovation and integration of appropriate safeguards\
        \ and risk mitigation measures. To ensure a legal framework that promotes\
        \ innovation, is future-proof and resilient to disruption, Member States should\
        \ ensure that their national competent authorities establish at least one\
        \ AI regulatory sandboxes at national level to facilitate the development\
        \ and testing of innovative AI systems under strict regulatory oversight before\
        \ these systems are placed on the market or otherwise put into service. Member\
        \ States could also fulfil this obligation through participating in already\
        \ existing regulatory sandboxes or establishing jointly a sandbox with one\
        \ or more Member States\u2019 competent authorities, insofar as this participation\
        \ provides equivalent level of national coverage for the participating Member\
        \ States. Regulatory sandboxes could be established in physical, digital or\
        \ hybrid form and may accommodate physical as well as digital products. Establishing\
        \ authorities should also ensure that the regulatory sandboxes have the adequate\
        \ resources for their functioning, including financial and human resources."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-139
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 139
      description: "The objectives of the AI regulatory sandboxes should be to foster\
        \ AI innovation by establishing a controlled experimentation and testing environment\
        \ in the development and pre-marketing phase with a view to ensuring compliance\
        \ of the innovative AI systems with this Regulation and other relevant Union\
        \ and national law, to enhance legal certainty for innovators and the competent\
        \ authorities\u2019 oversight and understanding of the opportunities, emerging\
        \ risks and the impacts of AI use, to facilitate regulatory learning for authorities\
        \ and undertakings, including with a view to future adaptions of the legal\
        \ framework, to support cooperation and the sharing of best practices with\
        \ the authorities involved in the AI regulatory sandbox, and to accelerate\
        \ access to markets, including by removing barriers for SMEs, including start-ups.\
        \ Regulatory sandboxes should be widely available throughout the Union, and\
        \ particular attention should be given to their accessibility for SMEs, including\
        \ start-ups. The participation in the AI regulatory sandbox should focus on\
        \ issues that raise legal uncertainty for providers and prospective providers\
        \ to innovate, experiment with AI in the Union and contribute to evidence-based\
        \ regulatory learning. The supervision of the AI systems in the AI regulatory\
        \ sandbox should therefore cover their development, training, testing and\
        \ validation before the systems are placed on the market or put into service,\
        \ as well as the notion and occurrence of substantial modification that may\
        \ require a new conformity assessment procedure. Any significant risks identified\
        \ during the development and testing of such AI systems should result in adequate\
        \ mitigation and, failing that, in the suspension of the development and testing\
        \ process.\nWhere appropriate, national competent authorities establishing\
        \ AI regulatory sandboxes should cooperate with other relevant authorities,\
        \ including those supervising the protection of fundamental rights,, and could\
        \ allow for the involvement of other actors within the AI ecosystem such as\
        \ national or European standardisation organisations, notified bodies, testing\
        \ and experimentation facilities, research and experimentation labs, European\
        \ Digital Innovation Hubs and relevant stakeholder and civil society organisations.\
        \ To ensure uniform implementation across the Union and economies of scale,\
        \ it is appropriate to establish common rules for the regulatory sandboxes\u2019\
        \ implementation and a framework for cooperation between the relevant authorities\
        \ involved in the supervision of the sandboxes. AI regulatory sandboxes established\
        \ under this Regulation should be without prejudice to other law allowing\
        \ for the establishment of other sandboxes aiming to ensure compliance with\
        \ Union law other that this Regulation. Where appropriate, relevant competent\
        \ authorities in charge of those other regulatory sandboxes should consider\
        \ the benefits of using those sandboxes also for the purpose of ensuring compliance\
        \ of AI systems with this Regulation. Upon agreement between the national\
        \ competent authorities and the participants in the AI regulatory sandbox,\
        \ testing in real world conditions may also be operated and supervised in\
        \ the framework of the AI regulatory sandbox."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-140
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 140
      description: This Regulation should provide the legal basis for the providers
        and prospective providers in the AI regulatory sandbox to use personal data
        collected for other purposes for developing certain AI systems in the public
        interest within the AI regulatory sandbox, only under specified conditions,
        in accordance with Article 6(4) and Article 9(2), point (g), of Regulation
        (EU) 2016/679, and Articles 5, 6 and 10 of Regulation (EU) 2018/1725, and
        without prejudice to Article 4(2) and Article 10 of Directive (EU) 2016/680.
        All other obligations of data controllers and rights of data subjects under
        Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 remain
        applicable. In particular, this Regulation should not provide a legal basis
        in the meaning of Article 22(2), point (b) of Regulation (EU) 2016/679 and
        Article 24(2), point (b) of Regulation (EU) 2018/1725. Providers and prospective
        providers in the sandbox should ensure appropriate safeguards and cooperate
        with the competent authorities, including by following their guidance and
        acting expeditiously and in good faith to adequately mitigate any identified
        - significant risks to safety, health, and fundamental rights that may arise
        during the development, testing and experimentation in the sandbox.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-141
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 141
      description: 'In order to accelerate the process of development and the placing
        on the market of the high-risk AI systems listed in an annex to this Regulation,
        it is important that providers or prospective providers of such systems may
        also benefit from a specific regime for testing those systems in real world
        conditions, without participating in an AI regulatory sandbox. However, in
        such cases and taking into account the possible consequences of such testing
        on individuals, it should be ensured that appropriate and sufficient guarantees
        and conditions are introduced by this Regulation for providers or prospective
        providers. Such guarantees should include, among others, requesting informed
        consent of natural persons to participate in testing in real world conditions,
        with the exception of law enforcement where the seeking of informed consent
        would prevent the AI system from being tested. Consent of subjects to participate
        in such testing under this Regulation is distinct from and without prejudice
        to consent of data subjects for the processing of their personal data under
        the relevant data protection law.

        It is also important to minimise the risks and enable oversight by competent
        authorities and therefore require prospective providers to have a real-world
        testing plan submitted to competent market surveillance authority, register
        the testing in dedicated sections in the EU database subject to some limited
        exceptions, set limitations on the period for which the testing can be done
        and require additional safeguards for vulnerable persons, including groups
        of vulnerable persons as well as a written agreement defining the roles and
        responsibilities of prospective providers and deployers and effective oversight
        by competent personnel involved in the real world testing. Furthermore, it
        is appropriate to envisage additional safeguards to ensure that the predictions,
        recommendations or decisions of the AI system can be effectively reversed
        and disregarded and that personal data is protected and is deleted when the
        subjects have withdrawn their consent to participate in the testing without
        prejudice to their rights as data subjects under the Union data protection
        law. As regards transfer of data, it is also appropriate to envisage that
        data collected and processed for the purpose of testing in real-world conditions
        should be transferred to third countries only where appropriate and applicable
        safeguards under Union law are implemented, in particular in accordance with
        bases for transfer of personal data under Union law on data protection, while
        for non-personal data appropriate safeguards are put in place in accordance
        with Union law, such as Regulations (EU) 2022/868 and (EU) 2023/2854 of the
        European Parliament and of the Council.'
    - urn: urn:intuitem:risk:req_node:ai-act:recital-142
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 142
      description: To ensure that AI leads to socially and environmentally beneficial
        outcomes, Member States are encouraged to support and promote research and
        development of AI solutions in support of socially and environmentally beneficial
        outcomes, such as AI-based solutions to increase accessibility for persons
        with disabilities, tackle socio-economic inequalities, or meet environmental
        targets, by allocating sufficient resources, including public and Union funding,
        and, where appropriate and provided that the eligibility and selection criteria
        are fulfilled, considering in particular projects which pursue such objectives.
        Such projects should be based on the principle of interdisciplinary cooperation
        between AI developers, experts on inequality and non-discrimination, accessibility,
        consumer, environmental, and digital rights, as well as academics.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-143
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 143
      description: "In order to promote and protect innovation, it is important that\
        \ the interests of SMEs, including start-ups, that are providers or deployers\
        \ of AI systems are taken into particular account. To this objective, Member\
        \ States should develop initiatives, which are targeted at those operators,\
        \ including on, awareness raising and information communication. Member States\
        \ shall provide SMEs, including start-ups, having a registered office or a\
        \ branch in the Union, with priority access to the AI regulatory sandboxes\
        \ provided that they fulfil the eligibility conditions and selection criteria\
        \ and without precluding other providers and prospective providers to access\
        \ the sandboxes provided the same conditions and criteria are fulfilled. Member\
        \ States shall utilise existing channels and where appropriate, establish\
        \ new dedicated channels for communication with SMEs, start-ups, deployers\
        \ other innovators and, as appropriate, local public authorities, to support\
        \ SMEs throughout their development path by providing guidance and responding\
        \ to queries about the implementation of this Regulation. Where appropriate,\
        \ these channels shall work together to create synergies and ensure homogeneity\
        \ in their guidance to SMEs, including start-ups, and deployers. Additionally,\
        \ Member States should facilitate the participation of SMEs and other relevant\
        \ stakeholders in the standardisation development processes. Moreover, the\
        \ specific interests and needs of SMEs, including start-ups, providers should\
        \ be taken into account when Notified Bodies set conformity assessment fees.\
        \ The Commission should regularly assess the certification and compliance\
        \ costs for SMEs, including start-ups, through transparent consultations deployers\
        \ and should work with Member States to lower such costs. \nFor example, translation\
        \ costs related to mandatory documentation and communication with authorities\
        \ may constitute a significant cost for providers and other operators, in\
        \ particular those of a smaller scale. Member States should possibly ensure\
        \ that one of the languages determined and accepted by them for relevant providers\u2019\
        \ documentation and for communication with operators is one which is broadly\
        \ understood by the largest possible number of cross-border deployers. In\
        \ order to address the specific needs of SMEs, including start-ups, the Commission\
        \ should provide standardised templates for the areas covered by this Regulation\
        \ upon request of the Board. Additionally, the Commission should complement\
        \ Member States\u2019 efforts by providing a single information platform with\
        \ easy-to-use information with regards to this Regulation for all providers\
        \ and deployers, by organising appropriate communication campaigns to raise\
        \ awareness about the obligations arising from this Regulation, and by evaluating\
        \ and promoting the convergence of best practices in public procurement procedures\
        \ in relation to AI systems. Medium-sized enterprises which were recently\
        \ small enterprises within the meaning of the Annex to Commission Recommendation\
        \ 2003/361/EC47 should have access to those support measures, as those new\
        \ medium-sized enterprises may sometimes lack the legal resources and training\
        \ necessary to ensure proper understanding of, and compliance with, this Regulation."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-144
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 144
      description: In order to promote and protect innovation, the AI-on-demand platform,
        all relevant Union funding programmes and projects, such as Digital Europe
        Programme, Horizon Europe, implemented by the Commission and the Member States
        at Union or national level should, as appropriate, contribute to the achievement
        of the objectives of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-145
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 145
      description: In particular, in order to minimise the risks to implementation
        resulting from lack of knowledge and expertise in the market as well as to
        facilitate compliance of providers, in particular SMEs, including start-ups,
        and notified bodies with their obligations under this Regulation, the AI-on-demand
        platform, the European Digital Innovation Hubs and the testing and experimentation
        facilities established by the Commission and the Member States at Union or
        national level should contribute to the implementation of this Regulation.
        Within their respective mission and fields of competence, the AI-on-demand
        platform, the European Digital Innovation Hubs and the testing and experimentation
        Facilities are able to provide in particular technical and scientific support
        to providers and notified bodies.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-146
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 146
      description: Moreover, in light of the very small size of some operators and
        in order to ensure proportionality regarding costs of innovation, it is appropriate
        to allow microenterprises to fulfil one of the most costly obligations, namely
        to establish a quality management system, in a simplified manner which would
        reduce the administrative burden and the costs for those enterprises without
        affecting the level of protection and the need for compliance with the requirements
        for high-risk AI systems. The Commission should develop guidelines to specify
        the elements of the quality management system to be fulfilled in this simplified
        manner by microentreprises.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-147
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 147
      description: It is appropriate that the Commission facilitates, to the extent
        possible, access to testing and experimentation facilities to bodies, groups
        or laboratories established or accredited pursuant to any relevant Union harmonisation
        legislation and which fulfil tasks in the context of conformity assessment
        of products or devices covered by that Union harmonisation legislation. This
        is, in particular, the case as regards expert panels, expert laboratories
        and reference laboratories in the field of medical devices pursuant to Regulations
        (EU) 2017/745 and (EU) 2017/746.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-148
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 148
      description: This Regulation should establish a governance framework that both
        allows to coordinate and support the application of this Regulation at national
        level, as well as build capabilities at Union level and integrate stakeholders
        in the field of AI. The effective implementation and enforcement of this Regulation
        require a governance framework that allows to coordinate and build up central
        expertise at Union level. The AI Office was established by Commission Decision
        and has as its mission to develop Union expertise and capabilities in the
        field of AI and to contribute to the implementation of Union law on AI. Member
        States should facilitate the tasks of the AI Office with a view to support
        the development of Union expertise and capabilities at Union level and to
        strengthen the functioning of the digital single market. Furthermore, a Board
        composed of representatives of the Member States, a scientific panel to integrate
        the scientific community and an advisory forum to contribute stakeholder input
        to the implementation of this Regulation, at Union and national level, should
        be established. The development of Union expertise and capabilities should
        also include making use of existing resources and expertise, in particular
        through synergies with structures built up in the context of the Union level
        enforcement of other law and synergies with related initiatives at Union level,
        such as the EuroHPC Joint Undertaking and the AI testing and experimentation
        facilities under the Digital Europe Programme.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-149
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 149
      description: In order to facilitate a smooth, effective and harmonised implementation
        of this Regulation a Board should be established. The Board should reflect
        the various interests of the AI eco-system and be composed of representatives
        of the Member States. The Board should be responsible for a number of advisory
        tasks, including issuing opinions, recommendations, advice or contributing
        to guidance on matters related to the implementation of this Regulation, including
        on enforcement matters, technical specifications or existing standards regarding
        the requirements established in this Regulation and providing advice to the
        Commission and the Member States and their national competent authorities
        on specific questions related to AI. In order to give some flexibility to
        Member States in the designation of their representatives in the Board, such
        representatives may be any persons belonging to public entities who should
        have the relevant competences and powers to facilitate coordination at national
        level and contribute to the achievement of the Board's tasks. The Board should
        establish two standing sub-groups to provide a platform for cooperation and
        exchange among market surveillance authorities and notifying authorities on
        issues related, respectively, to market surveillance and notified bodies.
        The standing subgroup for market surveillance should act as the administrative
        cooperation group (ADCO) for this Regulation within the meaning of Article
        30 of Regulation (EU) 2019/1020. In accordance with Article 33 of that Regulation,
        the Commission should support the activities of the standing subgroup for
        market surveillance by undertaking market evaluations or studies, in particular
        with a view to identifying aspects of this Regulation requiring specific and
        urgent coordination among market surveillance authorities. The Board may establish
        other standing or temporary sub-groups as appropriate for the purpose of examining
        specific issues. The Board should also cooperate, as appropriate, with relevant
        Union bodies, experts groups and networks active in the context of relevant
        Union law, including in particular those active under relevant Union law on
        data, digital products and services.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-150
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 150
      description: With a view to ensure the involvement of stakeholders in the implementation
        and application of this Regulation, an advisory forum should be established
        to advise and provide technical expertise to the Board and the Commission.
        To ensure a varied and balanced stakeholder representation between commercial
        and non-commercial interest and, within the category of commercial interests,
        with regards to SMEs and other undertakings, the advisory forum should comprise
        inter alia industry, start-ups, SMEs, academia, civil society, including the
        social partners, as well as the Fundamental Rights Agency, ENISA, the European
        Committee for Standardization (CEN), the European Committee for Electrotechnical
        Standardization (CENELEC) and the European Telecommunications Standards Institute
        (ETSI).
    - urn: urn:intuitem:risk:req_node:ai-act:recital-151
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 151
      description: To support the implementation and enforcement of this Regulation,
        in particular the monitoring activities of the AI Office as regards general-purpose
        AI models, a scientific panel of independent experts should be established.
        The independent experts constituting the scientific panel should be selected
        on the basis of up-to-date scientific or technical expertise in the field
        of AI and should perform their tasks with impartiality, objectivity and ensure
        the confidentiality of information and data obtained in carrying out their
        tasks and activities. To allow reinforcing national capacities necessary for
        the effective enforcement of this Regulation, Member States should be able
        to request support from the pool of experts constituting the scientific panel
        for their enforcement activities.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-152
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 152
      description: In order to support adequate enforcement as regards AI systems
        and reinforce the capacities of the Member States, Union AI testing support
        structures should be established and made available to the Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-153
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 153
      description: "Member States hold a key role in the application and enforcement\
        \ of this Regulation. In that respect, each Member State should designate\
        \ at least one notifying authority and at least one market surveillance authority\
        \ as national competent authorities for the purpose of supervising the application\
        \ and implementation of this Regulation. Member States may decide to appoint\
        \ any kind of public entity to perform the tasks of the national competent\
        \ authorities within the meaning of this Regulation, in accordance with their\
        \ specific national organisational characteristics and needs. In order to\
        \ increase organisation efficiency on the side of Member States and to set\
        \ a single point of contact vis-\xE0-vis the public and other counterparts\
        \ at Member State and Union levels, each Member State should designate a market\
        \ surveillance authority to act as a single point of contact."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-154
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 154
      description: The national competent authorities should exercise their powers
        independently, impartially and without bias, so as to safeguard the principles
        of objectivity of their activities and tasks and to ensure the application
        and implementation of this Regulation. The members of these authorities should
        refrain from any action incompatible with their duties and should be subject
        to confidentiality rules under this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-155
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 155
      description: "In order to ensure that providers of high-risk AI systems can\
        \ take into account the experience on the use of high-risk AI systems for\
        \ improving their systems and the design and development process or can take\
        \ any possible corrective action in a timely manner, all providers should\
        \ have a post-market monitoring system in place. Where relevant, post- market\
        \ monitoring should include an analysis of the interaction with other AI systems\
        \ including other devices and software. Post-market monitoring should not\
        \ cover sensitive operational data of deployers which are law enforcement\
        \ authorities. This system is also key to ensure that the possible risks emerging\
        \ from AI systems which continue to \u2018learn\u2019 after being placed on\
        \ the market or put into service can be more efficiently and timely addressed.\
        \ In this context, providers should also be required to have a system in place\
        \ to report to the relevant authorities any serious incidents resulting from\
        \ the use of their AI systems, meaning incident or malfunctioning leading\
        \ to death or serious damage to health, serious and irreversible disruption\
        \ of the management and operation of critical infrastructure, infringements\
        \ of obligations under Union law intended to protect fundamental rights or\
        \ serious damage to property or the environment."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-156
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 156
      description: In order to ensure an appropriate and effective enforcement of
        the requirements and obligations set out by this Regulation, which is Union
        harmonisation legislation, the system of market surveillance and compliance
        of products established by Regulation (EU) 2019/1020 should apply in its entirety.
        Market surveillance authorities designated pursuant to this Regulation should
        have all enforcement powers laid down in this Regulation and in Regulation
        (EU) 2019/1020 and should exercise their powers and carry out their duties
        independently, impartially and without bias. Although the majority of AI systems
        are not subject to specific requirements and obligations under this Regulation,
        market surveillance authorities may take measures in relation to all AI systems
        when they present a risk in accordance with this Regulation. Due to the specific
        nature of Union institutions, agencies and bodies falling within the scope
        of this Regulation, it is appropriate to designate the European Data Protection
        Supervisor as a competent market surveillance authority for them. This should
        be without prejudice to the designation of national competent authorities
        by the Member States. Market surveillance activities should not affect the
        ability of the supervised entities to carry out their tasks independently,
        when such independence is required by Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-157
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 157
      description: This Regulation is without prejudice to the competences, tasks,
        powers and independence of relevant national public authorities or bodies
        which supervise the application of Union law protecting fundamental rights,
        including equality bodies and data protection authorities. Where necessary
        for their mandate, those national public authorities or bodies should also
        have access to any documentation created under this Regulation. A specific
        safeguard procedure should be set for ensuring adequate and timely enforcement
        against AI systems presenting a risk to health, safety and fundamental rights.
        The procedure for such AI systems presenting a risk should be applied to high-risk
        AI systems presenting a risk, prohibited systems which have been placed on
        the market, put into service or used in violation of the prohibited practices
        laid down in this Regulation and AI systems which have been made available
        in violation of the transparency requirements laid down in this Regulation
        and present a risk.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-158
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 158
      description: "Union financial services law includes internal governance and\
        \ risk-management rules and requirements which are applicable to regulated\
        \ financial institutions in the course of provision of those services, including\
        \ when they make use of AI systems. In order to ensure coherent application\
        \ and enforcement of the obligations under this Regulation and relevant rules\
        \ and requirements of the Union financial services legal acts, the competent\
        \ authorities for the supervision and enforcement of those legal acts, in\
        \ particular competent authorities as defined in Regulation (EU) No 575/2013\
        \ of the European Parliament and of the Council and Directives 2008/48/EC,\
        \ 2009/138/EC, 2013/36/EU, 2014/17/EU and (EU) 2016/97 of the European Parliament\
        \ and of the Council, should be designated, within their respective competences,\
        \ as competent authorities for the purpose of supervising the implementation\
        \ of this Regulation, including for market surveillance activities, as regards\
        \ AI systems provided or used by regulated and supervised financial institutions\
        \ unless Member States decide to designate another authority to fulfil these\
        \ market surveillance tasks.\nThose competent authorities should have all\
        \ powers under this Regulation and Regulation (EU) 2019/1020 to enforce the\
        \ requirements and obligations of this Regulation, including powers to carry\
        \ our ex post market surveillance activities that can be integrated, as appropriate,\
        \ into their existing supervisory mechanisms and procedures under the relevant\
        \ Union financial services law. It is appropriate to envisage that, when acting\
        \ as market surveillance authorities under this Regulation, the national authorities\
        \ responsible for the supervision of credit institutions regulated under Directive\
        \ 2013/36/EU, which are participating in the Single Supervisory Mechanism\
        \ established by Council Regulation (EU) No 1024/2013, should report, without\
        \ delay, to the European Central Bank any information identified in the course\
        \ of their market surveillance activities that may be of potential interest\
        \ for the European Central Bank\u2019s prudential supervisory tasks as specified\
        \ in that Regulation.\nTo further enhance the consistency between this Regulation\
        \ and the rules applicable to credit institutions regulated under Directive\
        \ 2013/36/EU, it is also appropriate to integrate  some of the providers\u2019\
        \ procedural obligations in relation to risk management, post marketing monitoring\
        \ and documentation into the existing obligations and procedures under Directive\
        \ 2013/36/EU. In order to avoid overlaps, limited derogations should also\
        \ be envisaged in relation to the quality management system of providers and\
        \ the monitoring obligation placed on deployers of high-risk AI systems to\
        \ the extent that these apply to credit institutions regulated by Directive\
        \ 2013/36/EU. The same regime should apply to insurance and re-insurance undertakings\
        \ and insurance holding companies under Directive 2009/138/EC and the insurance\
        \ intermediaries under Directive (EU) 2016/97 and other types of financial\
        \ institutions subject to requirements regarding internal governance, arrangements\
        \ or processes established pursuant to the relevant Union financial services\
        \ law to ensure consistency and equal treatment in the financial sector."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-159
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 159
      description: Each market surveillance authority for high-risk AI systems in
        the area of biometrics, as listed in an annex to this Regulation insofar as
        those systems are used for the purposes of law enforcement, migration, asylum
        and border control management, or the administration of justice and democratic
        processes, should have effective investigative and corrective powers, including
        at least the power to obtain access to all personal data that are being processed
        and to all information necessary for the performance of its tasks. The market
        surveillance authorities should be able to exercise their powers by acting
        with complete independence. Any limitations of their access to sensitive operational
        data under this Regulation should be without prejudice to the powers conferred
        to them by Directive (EU) 2016/680. No exclusion on disclosing data to national
        data protection authorities under this Regulation should affect the current
        or future powers of those authorities beyond the scope of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-160
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 160
      description: The market surveillance authorities of the Member States and the
        Commission should be able to propose joint activities, including joint investigations,
        to be conducted by market surveillance authorities or market surveillance
        authorities jointly with the Commission, that have the aim of promoting compliance,
        identifying non-compliance, raising awareness and providing guidance in relation
        to this Regulation with respect to specific categories of high-risk AI systems
        that are found to present a serious risk across two or more Member States.
        Joint activities to promote compliance should be carried out in accordance
        with Article 9 of Regulation (EU) 2019/1020. The AI Office should provide
        coordination support for joint investigations.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-161
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 161
      description: It is necessary to clarify the responsibilities and competences
        at Union and national level as regards AI systems that are built on general-purpose
        AI models. To avoid overlapping competences, where an AI system is based on
        a general-purpose AI model and the model and system are provided by the same
        provider, the supervision should take place at Union level through the AI
        Office, which should have the powers of a market surveillance authority within
        the meaning of Regulation (EU) 2019/1020 for this purpose. In all other cases,
        national market surveillance authorities remain responsible for the supervision
        of AI systems. However, for general-purpose AI systems that can be used directly
        by deployers for at least one purpose that is classified as high-risk, market
        surveillance authorities should cooperate with the AI Office to carry out
        evaluations of compliance and inform the Board and other market surveillance
        authorities accordingly. Furthermore, market surveillance authorities should
        be able to request assistance from the AI Office where the market surveillance
        authority is unable to conclude an investigation on a high-risk AI system
        because of its inability to access certain information related to the general-purpose
        AI model on which the high-risk AI system is built. In such cases, the procedure
        regarding mutual assistance in cross-border cases in Chapter VI of Regulation
        (EU) 2019/1020 should apply mutatis mutandis.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-162
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 162
      description: To make best use of the centralised Union expertise and synergies
        at Union level, the powers of supervision and enforcement of the obligations
        on providers of general- purpose AI models should be a competence of the Commission.
        The Commission should entrust the implementation of these tasks to the AI
        Office, without prejudice to the powers of organisation of the Commission
        and the division of competences between Member States and the Union based
        on the Treaties. The AI Office should be able to carry out all necessary actions
        to monitor the effective implementation of this Regulation as regards general-purpose
        AI models. It should be able to investigate possible infringements of the
        rules on providers of general-purpose AI models both on its own initiative,
        following the results of its monitoring activities, or upon request from market
        surveillance authorities in line with the conditions set out in this Regulation.
        To support effective monitoring of the AI Office, it should provide for the
        possibility that downstream providers lodge complaints about possible infringements
        of the rules on providers of general-purpose AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-163
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 163
      description: With a view to complement the governance systems for general-purpose
        AI models, the scientific panel should support the monitoring activities of
        the AI Office and may, in certain cases, provide qualified alerts to the AI
        Office which trigger follow-ups such as investigations. This should be the
        case where the scientific panel has reason to suspect that a general-purpose
        AI model poses a concrete and identifiable risk at Union level. Furthermore,
        this should be the case where the scientific panel has reason to suspect that
        a general-purpose AI model meets the criteria that would lead to a classification
        as general-purpose AI model with systemic risk. To equip the scientific panel
        with the information necessary for the performance of those tasks, there should
        be a mechanism whereby the scientific panel can request the Commission to
        require documentation or information from a provider.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-164
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 164
      description: The AI Office should be able to take the necessary actions to monitor
        the effective implementation of and compliance with the obligations for providers
        of general-purpose AI models laid down in this Regulation. The AI Office should
        be able to investigate possible infringements in accordance with the powers
        provided for in this Regulation, including by requesting documentation and
        information, by conducting evaluations, as well as by requesting measures
        from providers of general-purpose AI models. In the conduct of evaluations,
        in order to make use of independent expertise, the AI Office should be able
        to involve independent experts to carry out the evaluations on its behalf.
        Compliance with the obligations should be enforceable, inter alia, through
        requests to take appropriate measures, including risk mitigation measures
        in the case of identified systemic risks as well as restricting the making
        available on the market, withdrawing or recalling the model. As a safeguard,
        where needed beyond the procedural rights provided for in this Regulation,
        providers of general-purpose AI models should have the procedural rights provided
        for in Article 18 of Regulation (EU) 2019/1020, which should apply mutatis
        mutandis, without prejudice to more specific procedural rights provided for
        by this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-165
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 165
      description: "The development of AI systems other than high-risk AI systems\
        \ in accordance with the requirements of this Regulation may lead to a larger\
        \ uptake of ethical and trustworthy AI in the Union. Providers of AI systems\
        \ that are not high-risk should be encouraged to create codes of conduct,\
        \ including related governance mechanisms, intended to foster the voluntary\
        \ application of some or all of the mandatory requirements applicable to high-risk\
        \ AI systems, adapted in light of the intended purpose of the systems and\
        \ the lower risk involved and taking into account the available technical\
        \ solutions and industry best practices such as model and data cards. Providers\
        \ and, as appropriate, deployers of all AI systems, high-risk or not, and\
        \ AI models should also be encouraged to apply on a voluntary basis additional\
        \ requirements related, for example, to the elements of the Union\u2019s Ethics\
        \ Guidelines for Trustworthy AI, environmental sustainability, AI literacy\
        \ measures, inclusive and diverse design and development of AI systems, including\
        \ attention to vulnerable persons and accessibility to persons with disability,\
        \ stakeholders\u2019 participation with the involvement, as appropriate, of\
        \ relevant stakeholders such as business and civil society organisations,\
        \ academia, research organisations, trade unions and consumer protection organisation\
        \ in the design and development of AI systems, and diversity of the development\
        \ teams, including gender balance. To ensure that the voluntary codes of conduct\
        \ are effective, they should be based on clear objectives and key performance\
        \ indicators to measure the achievement of those objectives. They should also\
        \ be developed in an inclusive way, as appropriate, with the involvement of\
        \ relevant stakeholders such as business and civil society organisations,\
        \ academia, research organisations, trade unions and consumer protection organisation.\
        \ The Commission may develop initiatives, including of a sectorial nature,\
        \ to facilitate the lowering of technical barriers hindering cross-border\
        \ exchange of data for AI development, including on data access infrastructure,\
        \ semantic and technical interoperability of different types of data."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-166
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 166
      description: It is important that AI systems related to products that are not
        high-risk in accordance with this Regulation and thus are not required to
        comply with the requirements set out for high- risk AI systems are nevertheless
        safe when placed on the market or put into service. To contribute to this
        objective, Regulation (EU) 2023/988 of the European Parliament and of the
        Council would apply as a safety net.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-167
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 167
      description: In order to ensure trustful and constructive cooperation of competent
        authorities on Union and national level, all parties involved in the application
        of this Regulation should respect the confidentiality of information and data
        obtained in carrying out their tasks, in accordance with Union or national
        law. They should carry out their tasks and activities in such a manner as
        to protect, in particular, intellectual property rights, confidential business
        information and trade secrets, the effective implementation of this Regulation,
        public and national security interests, the integrity of criminal and administrative
        proceedings, and the integrity of classified information.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-168
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 168
      description: Compliance with this Regulation should be enforceable by means
        of the imposition of penalties and other enforcement measures. Member States
        should take all necessary measures to ensure that the provisions of this Regulation
        are implemented, including by laying down effective, proportionate and dissuasive
        penalties for their infringement, including in respect of the ne bis in idem
        principle. In order to strengthen and harmonise administrative penalties for
        infringement of this Regulation, the upper limits for setting the administrative
        fines for certain specific infringements should be laid down. When assessing
        the amount of the fines, Member States should, in each individual case, take
        into account all relevant circumstances of the specific situation, with due
        regard in particular to the nature, gravity and duration of the infringement
        and of its consequences and to the size of the provider, in particular if
        the provider is an SME, including a start-up. The European Data Protection
        Supervisor should have the power to impose fines on Union institutions, agencies
        and bodies falling within the scope of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-169
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 169
      description: Compliance with the obligations on providers of general-purpose
        AI models imposed under this Regulation should be enforceable among others
        by means of fines. To that end, appropriate levels of fines should also be
        laid down for infringement of those obligations, including the failure to
        comply with measures requested by the Commission in accordance with this Regulation,
        subject to appropriate limitation periods in accordance with the principle
        of proportionality. All decisions taken by the Commission under this Regulation
        are subject to review by the Court of Justice of the European Union in accordance
        with the TFEU.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-170
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 170
      description: Union and national law already provide effective remedies to natural
        and legal persons whose rights and freedoms are adversely affected by the
        use of AI systems. Without prejudice to those remedies, any natural or legal
        person that has grounds to consider that there has been an infringement of
        this Regulation should be entitled to lodge a complaint to the relevant market
        surveillance authority.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-171
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 171
      description: "Affected persons should have the right to obtain an explanation\
        \ where a deployer\u2019s decision is based mainly upon the output from certain\
        \ high-risk systems that fall within the scope of this Regulation and where\
        \ that decision produces legal effects or similarly significantly affects\
        \ those persons in a way that they consider to have an adverse impact on their\
        \ health, safety or fundamental rights. That explanation should be clear and\
        \ meaningful and should provide a basis on which the affected persons are\
        \ able to exercise their rights. The right to obtain an explanation should\
        \ not apply to the use of AI systems for which exceptions or restrictions\
        \ follow from Union or national law and should apply only to the extent this\
        \ right is not already provided for under Union law."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-172
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 172
      description: Persons acting as whistleblowers on the infringements of this Regulation
        should be protected under the Union law. Directive (EU) 2019/1937 of the European
        Parliament and of the Council should therefore apply to the reporting of infringements
        of this Regulation and the protection of persons reporting such infringements.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-173
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 173
      description: "In order to ensure that the regulatory framework can be adapted\
        \ where necessary, the power to adopt acts in accordance with Article 290\
        \ TFEU should be delegated to the Commission to amend the conditions under\
        \ which an AI system shall not be considered as high-risk, the list of high-risk\
        \ AI systems, the provisions regarding technical documentation, the content\
        \ of the EU declaration of conformity the provisions regarding the conformity\
        \ assessment procedures, the provisions establishing the high-risk AI systems\
        \ to which the conformity assessment procedure based on assessment of the\
        \ quality management system and assessment of the technical documentation\
        \ should apply, the threshold, benchmarks and indicators, including by supplementing\
        \ those benchmarks and indicators, in the rules for the classification of\
        \ general-purpose AI models with systemic risk, the criteria for the designation\
        \ of general-purpose AI models with systemic risk, the technical documentation\
        \ for providers of general-purpose AI models and the transparency information\
        \ for providers of general-purpose AI models. It is of particular importance\
        \ that the Commission carry out appropriate consultations during its preparatory\
        \ work, including at expert level, and that those consultations be conducted\
        \ in accordance with the principles laid down in the Interinstitutional Agreement\
        \ of 13 April 2016 on Better Law-Making58. In particular, to ensure equal\
        \ participation in the preparation of delegated acts, the European Parliament\
        \ and the Council receive all documents at the same time as Member States\u2019\
        \ experts, and their experts systematically have access to meetings of Commission\
        \ expert groups dealing with the preparation of delegated acts."
    - urn: urn:intuitem:risk:req_node:ai-act:recital-174
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 174
      description: Given the rapid technological developments and the technical expertise
        required to effectively apply this Regulation, the Commission should evaluate
        and review this Regulation by 2 August 2029 and every four years thereafter
        and report to the European Parliament and the Council. In addition, taking
        into account the implications for the scope of this Regulation, the Commission
        should carry out an assessment of the need to amend the list of high-risk
        AI systems and the list of prohibited practices once a year. Moreover, by
        2 August 2028 and every four years thereafter, the Commission should evaluate
        and report to the European Parliament and to the Council on the need to amend
        the list of high-risk areas headings in the annex to this Regulation, the
        AI systems within the scope of the transparency obligations, the effectiveness
        of the supervision and governance system and the progress on the development
        of standardisation deliverables on energy efficient development of general-purpose
        AI models, including the need for further measures or actions. Finally, by
        2 August 2028 and every three years thereafter, the Commission should evaluate
        the impact and effectiveness of voluntary codes of conduct to foster the application
        of the requirements provided for high-risk AI systems in the case of AI systems
        other than high-risk AI systems and possibly other additional requirements
        for such AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-175
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 175
      description: In order to ensure uniform conditions for the implementation of
        this Regulation, implementing powers should be conferred on the Commission.
        Those powers should be exercised in accordance with Regulation (EU) No 182/2011
        of the European Parliament and of the Council.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-176
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 176
      description: Since the objective of this Regulation, namely to improve the functioning
        of the internal market and promoting the uptake of human centric and trustworthy
        AI, while ensuring a high level of protection of health, safety, fundamental
        rights enshrined in the Charter, including democracy, the rule of law and
        environmental protection against harmful effects of AI systems in the Union
        and supporting innovation, cannot be sufficiently achieved by the Member States
        and can rather, by reason of the scale or effects of the action, be better
        achieved at Union level, the Union may adopt measures in accordance with the
        principle of subsidiarity as set out in Article 5 TEU. In accordance with
        the principle of proportionality as set out in that Article, this Regulation
        does not go beyond what is necessary in order to achieve that objective.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-177
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 177
      description: In order to ensure legal certainty, ensure an appropriate adaptation
        period for operators and avoid disruption to the market, including by ensuring
        continuity of the use of AI systems, it is appropriate that this Regulation
        applies to the high-risk AI systems that have been placed on the market or
        put into service before the general date of application thereof, only if,
        from that date, those systems are subject to significant changes in their
        design or intended purpose. It is appropriate to clarify that, in this respect,
        the concept of significant change should be understood as equivalent in substance
        to the notion of substantial modification, which is used with regard only
        to high-risk AI systems pursuant to this Regulation. On an exceptional basis
        and in light of public accountability, operators of AI systems which are components
        of the large-scale IT systems established by the legal acts listed in an annex
        to this Regulation and operators of high-risk AI systems that are intended
        to be used by public authorities should, respectively, take the necessary
        steps to comply with the requirements of this Regulation by end of 2030 and
        by six years after the entry into force.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-178
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 178
      description: Providers of high-risk AI systems are encouraged to start to comply,
        on a voluntary basis, with the relevant obligations of this Regulation already
        during the transitional period.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-179
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 179
      description: This Regulation should apply from 2 August 2026. However, taking
        into account the unacceptable risk associated with the use of AI in certain
        ways, the prohibitions as well as the general provisions of this Regulation
        should already apply from 2 February 2025. While the full effect of those
        prohibitions follows with the establishment of the governance and enforcement
        of this Regulation, anticipating the application of the prohibitions is important
        to take account of unacceptable risks and to have an effect on other procedures,
        such as in civil law. Moreover, the infrastructure related to the governance
        and the conformity assessment system should be operational before 2 August
        2026, therefore the provisions on notified bodies and governance structure
        should apply from 2 August 2025. Given the rapid pace of technological advancements
        and adoption of general-purpose AI models, obligations for providers of general-purpose
        AI models should apply from 2 August 2025. Codes of practice should be ready
        by 2 May 2025 in view of enabling providers to demonstrate compliance on time.
        The AI Office should ensure that classification rules and procedures are up
        to date in light of technological developments. In addition, Member States
        should lay down and notify to the Commission the rules on penalties, including
        administrative fines, and ensure that they are properly and effectively implemented
        by the date of application of this Regulation. Therefore the provisions on
        penalties should apply from 2 August 2025.
    - urn: urn:intuitem:risk:req_node:ai-act:recital-180
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node2
      ref_id: Recital 180
      description: The European Data Protection Supervisor and the European Data Protection
        Board were consulted in accordance with Article 42(1) and (2) of Regulation
        (EU) 2018/1725 and delivered their joint opinion on  18 June 2021,
    - urn: urn:intuitem:risk:req_node:ai-act:node183
      assessable: false
      depth: 1
      name: CHAPTER I
      description: GENERAL PROVISIONS
    - urn: urn:intuitem:risk:req_node:ai-act:node184
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node183
      name: Article 1
      description: 'Subject matter` '
    - urn: urn:intuitem:risk:req_node:ai-act:1.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node184
      ref_id: '1.1'
      description: The purpose of this Regulation is to improve the functioning of
        the internal market and promote the uptake of human-centric and trustworthy
        artificial intelligence (AI), while ensuring a high level of protection of
        health, safety, fundamental rights enshrined in the Charter of Fundamental
        Rights, including democracy, the rule of law and environmental protection,
        against the harmful effects of artificial intelligence systems (AI systems)
        in the Union, and to support innovation.
    - urn: urn:intuitem:risk:req_node:ai-act:1.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node184
      ref_id: '1.2'
      description: 'This Regulation lays down:

        (a) harmonised rules for the placing on the market, the putting into service,
        and the use of AI systems in the Union;

        (b) prohibitions of certain AI practices;

        (c) specific requirements for high-risk AI systems and obligations for operators
        of such systems;

        (d) harmonised transparency rules for certain AI systems;

        (e) harmonised rules for the placing on the market of general-purpose AI models;

        (f) rules on market monitoring, market surveillance governance and enforcement;

        (g) measures to support innovation, with a particular focus on SMEs, including
        start- ups.'
    - urn: urn:intuitem:risk:req_node:ai-act:node187
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node183
      name: 'Article 2 '
      description: 'Scope '
    - urn: urn:intuitem:risk:req_node:ai-act:2.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.1'
      description: 'This Regulation applies to:

        (a) providers placing on the market or putting into service AI systems or
        placing on the market general-purpose AI models in the Union, irrespective
        of whether those providers are established or located within the Union or
        in a third country;

        (b) deployers of AI systems that have their place of establishment or are
        located within the Union;

        (c) providers and deployers of AI systems that have their place of establishment
        or are located in a third country, where the output produced by the AI system
        is used in the Union;

        (d) importers and distributors of AI systems;

        (e) product manufacturers placing on the market or putting into service an
        AI system together with their product and under their own name or trademark;

        (f) authorised representatives of providers, which are not established in
        the Union;

        (g) affected persons that are located in the Union.'
    - urn: urn:intuitem:risk:req_node:ai-act:2.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.2'
      description: For  AI systems classified as high-risk AI systems in accordance
        with Article 6(1) and (2) related to products covered by the Union harmonisation
        legislation listed in section B of Annex I, only Article 112 applies. Article
        57 applies only in so far as the requirements for high-risk AI systems under
        this Regulation have been integrated in that Union harmonisation legislation.
    - urn: urn:intuitem:risk:req_node:ai-act:2.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.3'
      description: 'This Regulation does not apply to areas outside the scope of Union
        law, and shall not, in any event, affect the competences of the Member States
        concerning national security, regardless of the type of entity entrusted by
        the Member States with carrying out tasks in relation to those competences.

        This Regulation does not apply to AI systems where and in so far they are
        placed on the market, put into service, or used with or without modification
        exclusively for military, defence or national security purposes, regardless
        of the type of entity carrying out those activities.

        This Regulation does not apply to AI systems which are not placed on the market
        or put into service in the Union, where the output is used in the Union exclusively
        for military, defence or national security purposes, regardless of the type
        of entity carrying out those activities.'
    - urn: urn:intuitem:risk:req_node:ai-act:2.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.4'
      description: This Regulation applies neither to public authorities in a third
        country nor to international organisations falling within the scope of this
        Regulation pursuant to paragraph 1, where those authorities or organisations
        use AI systems in the framework of international cooperation or agreements
        for law enforcement and judicial cooperation with the Union or with one or
        more Member States, provided that such a third country or international organisation
        provides adequate safeguards with respect to the protection of fundamental
        rights and freedoms of individuals.
    - urn: urn:intuitem:risk:req_node:ai-act:2.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.5'
      description: This Regulation shall not affect the application of the provisions
        on the liability of providers of intermediary services as set out in Chapter
        II of Regulation (EU) 2022/2065.
    - urn: urn:intuitem:risk:req_node:ai-act:2.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.6'
      description: This Regulation does not apply to AI systems or AI models, including
        their output, specifically developed and put into service for the sole purpose
        of scientific research and development.
    - urn: urn:intuitem:risk:req_node:ai-act:2.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.7'
      description: Union law on the protection of personal data, privacy and the confidentiality
        of communications applies to personal data processed in connection with the
        rights and obligations laid down in this Regulation. This Regulation shall
        not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC
        or (EU) 2016/680, without prejudice to the arrangements provided for in Article
        10(5) and Article 59 of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:2.8
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.8'
      description: This Regulation does not apply to any research, testing or development
        activity regarding AI systems or models prior to their being placed on the
        market or put into service. Such activities shall be conducted in accordance
        with applicable Union law. Testing in real world conditions shall not be covered
        by that exclusion.
    - urn: urn:intuitem:risk:req_node:ai-act:2.9
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.9'
      description: This Regulation is without prejudice to the rules laid down by
        other Union legal acts related to consumer protection and product safety.
    - urn: urn:intuitem:risk:req_node:ai-act:2.10
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.10'
      description: This Regulation does not apply to obligations of deployers who
        are natural persons using AI systems in the course of a purely personal non-professional
        activity.
    - urn: urn:intuitem:risk:req_node:ai-act:2.11
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.11'
      description: This Regulation does not preclude the Union or Member States from
        maintaining or introducing laws, regulations or administrative provisions
        which are more favourable to workers in terms of protecting their rights in
        respect of the use of AI systems by employers, or from encouraging or allowing
        the application of collective agreements which are more favourable to workers.
    - urn: urn:intuitem:risk:req_node:ai-act:2.12
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node187
      ref_id: '2.12'
      description: This Regulation applies to AI systems released under free and open
        source licences, unless they are placed on the market or put into service
        as high-risk AI systems or as an AI system that falls under Article 5 or 50.
    - urn: urn:intuitem:risk:req_node:ai-act:node200
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node183
      name: 'Article 3 '
      description: Definitions
    - urn: urn:intuitem:risk:req_node:ai-act:3.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node200
      ref_id: '3.1'
      description: 'For the purposes of this Regulation, the following definitions
        apply:'
    - urn: urn:intuitem:risk:req_node:ai-act:3.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.2'
      description: "\u2018AI system\u2019 means a machine-based system designed to\
        \ operate with varying levels of autonomy, that may exhibit adaptiveness after\
        \ deployment and that, for explicit or implicit objectives, infers, from the\
        \ input it receives, how to generate outputs such as predictions, content,\
        \ recommendations, or decisions that can influence physical or virtual environments;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.3'
      description: "\u2018risk\u2019 means the combination of the probability of an\
        \ occurrence of harm and the severity of that harm;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.4'
      description: "\u2018provider\u2019 means a natural or legal person, public authority,\
        \ agency or other body that develops an AI system or a general-purpose AI\
        \ model or that has an AI system or a general-purpose AI model developed and\
        \ places it on the market or puts the AI system into service under its own\
        \ name or trademark, whether for payment or free of charge;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.5'
      description: "\u2018deployer\u2019 means a natural or legal person, public authority,\
        \ agency or other body using an AI system under its authority  except where\
        \ the AI system is used in the course of a personal non-professional activity;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.6'
      description: "\u2018authorised representative\u2019 means a natural or legal\
        \ person located or established in the Union who has received and accepted\
        \ a written mandate from a provider of an AI system or a general-purpose AI\
        \ model to, respectively, perform and carry out on its behalf the obligations\
        \ and procedures established by this Regulation;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.7'
      description: "\u2018importer\u2019 means a natural or legal person located or\
        \ established in the Union that places on the market  an AI system that bears\
        \ the name or trademark of a natural or legal person established in a third\
        \ country;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.8'
      description: "\u2018distributor\u2019 means a natural or legal person in the\
        \ supply chain, other than the provider or the importer, that makes an AI\
        \ system available on the Union market ;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.9'
      description: "\u2018operator\u2019 means a provider, product manufacturer, deployer,\
        \ authorised representative, importer or distributor;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.10
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.10'
      description: "\u2018placing on the market\u2019 means the first making available\
        \ of an AI system or a general- purpose AI model on the Union market;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.11
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.11'
      description: "\u2018making available on the market\u2019 means the supply of\
        \ an AI system or a general-purpose AI model for distribution or use on the\
        \ Union market in the course of a commercial activity, whether in return for\
        \ payment or free of charge;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.12
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.12'
      description: "\u2018putting into service\u2019 means the supply of an AI system\
        \ by the provider for first use directly to the deployer or for own use in\
        \ the Union  for its intended purpose;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.13
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.13'
      description: "\u2018intended purpose\u2019 means the use for which an AI system\
        \ is intended by the provider, including the specific context and conditions\
        \ of use, as specified in the information supplied by the provider in the\
        \ instructions for use, promotional or sales materials and statements, as\
        \ well as in the technical documentation;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.14
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.14'
      description: "\u2018reasonably foreseeable misuse\u2019 means the use of an\
        \ AI system in a way that is not in accordance with its intended purpose,\
        \ but which may result from reasonably foreseeable human behaviour or interaction\
        \ with other systems, including other AI systems;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.15
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.15'
      description: "\u2018safety component\u2019 means a component of a product or\
        \ of a system which fulfils a safety function for that product or system,\
        \ or the failure or malfunctioning of which endangers the health and safety\
        \ of persons or property;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.16
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.16'
      description: "\u2018instructions for use\u2019 means the information provided\
        \ by the provider to inform the deployer of in particular an AI system\u2019\
        s intended purpose and proper use ;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.17
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.17'
      description: "\u2018recall of an AI system\u2019 means any measure aiming to\
        \ achieve the return to the provider or taking out of service or disabling\
        \ the use of an AI system made available to deployers;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.18
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.18'
      description: "\u2018withdrawal of an AI system\u2019 means any measure aiming\
        \ to prevent an AI system in the supply chain being made available on the\
        \ market;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.19
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.19'
      description: "\u2018performance of an AI system\u2019 means the ability of an\
        \ AI system to achieve its intended purpose;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.20
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.20'
      description: "\u2018notifying authority\u2019 means the national authority responsible\
        \ for setting up and carrying out the necessary procedures for the assessment,\
        \ designation and notification of conformity assessment bodies and for their\
        \ monitoring;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.21
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.21'
      description: "\u2018conformity assessment\u2019 means the process of demonstrating\
        \ whether the requirements set out in Chapter II, Section 2 relating to a\
        \ high-risk AI system have been fulfilled;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.22
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.22'
      description: "\u2018conformity assessment body\u2019 means a body that performs\
        \ third-party conformity assessment activities, including testing, certification\
        \ and inspection;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.23
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.23'
      description: "\u2018notified body\u2019 means a conformity assessment body notified\
        \ in accordance with this Regulation and other relevant Union harmonisation\
        \ legislation as listed in Section B of Annex I;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.24
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.24'
      description: "\u2018substantial modification\u2019 means a change to an AI system\
        \ after its placing on the market or putting into service which is not foreseen\
        \ or planned in the initial conformity assessment carried out by the provider\
        \ and as a result of which the compliance of the AI system with the requirements\
        \ set out in Chapter II, Section 2 is affected or results in a modification\
        \ to the intended purpose for which the AI system has been assessed;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.25
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.25'
      description: "\u2018CE marking\u2019 means a marking by which a provider indicates\
        \ that an AI system is in conformity with the requirements set out in Chapter\
        \ II, Section 2 and other applicable Union harmonisation legislation listed\
        \ in Annex I, providing for its affixing;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.26
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.26'
      description: "\u2018post-market monitoring system\u2019 means all activities\
        \ carried out by providers of AI systems to collect and review experience\
        \ gained from the use of AI systems they place on the market or put into service\
        \ for the purpose of identifying any need to immediately apply any necessary\
        \ corrective or preventive actions;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.27
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.27'
      description: "\u2018market surveillance authority\u2019 means the national authority\
        \ carrying out the activities and taking the measures pursuant to Regulation\
        \ (EU) 2019/1020;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.28
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.28'
      description: "\u2018harmonised standard\u2019 means a harmonised standard as\
        \ defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.29
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.29'
      description: "\u2018common specification\u2019 means a set of technical specifications\
        \ as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing\
        \ means to  comply with certain requirements  established under this Regulation;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.30
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.30'
      description: "\u2018training data\u2019 means data used for training an AI system\
        \ through fitting its learnable parameters ;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.31
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.31'
      description: "\u2018validation data\u2019 means data used for providing an evaluation\
        \ of the trained AI system and for tuning its non-learnable parameters and\
        \ its learning process in order, inter alia, to prevent underfitting or overfitting;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.32
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.32'
      description: "\u2018validation data set\u2019 means a separate data set or part\
        \ of the training data set, either as a fixed or variable split;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.33
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.33'
      description: "\u2018testing data\u2019 means data used for providing an independent\
        \ evaluation of the  AI system in order to confirm the expected performance\
        \ of that system before its placing on the market or putting into service;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.34
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.34'
      description: "\u2018input data\u2019 means data provided to or directly acquired\
        \ by an AI system on the basis of which the system produces an output;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.35
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.35'
      description: "\u2018biometric data\u2019 means personal data resulting from\
        \ specific technical processing relating to the physical, physiological or\
        \ behavioural characteristics of a natural person,  such as facial images\
        \ or dactyloscopic data;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.36
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.36'
      description: "\u2018biometric identification\u2019 means the automated recognition\
        \ of physical, physiological, behavioural, or psychological human features\
        \ for the purpose of establishing the identity of a natural person by comparing\
        \ biometric data of that individual to biometric data of individuals stored\
        \ in a database;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.37
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.37'
      description: "\u2018biometric verification\u2019 means the automated, one-to-one\
        \ verification, including authentication, of the identity of natural persons\
        \ by comparing their biometric data to previously provided biometric data;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.38
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.38'
      description: "special categories of personal data\u2019 means the categories\
        \ of personal data referred to in Article 9(1) of Regulation (EU) 2016/679,\
        \ Article 10 of Directive (EU) 2016/680 and Article 10(1) of Regulation (EU)\
        \ 2018/1725;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.39
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.39'
      description: "sensitive operational data\u2019 means operational data related\
        \ to activities of prevention, detection, investigation or prosecution of\
        \ criminal offences, the disclosure of which could jeopardise the integrity\
        \ of criminal proceedings;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.40
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.40'
      description: "\u2018emotion recognition system\u2019 means an AI system for\
        \ the purpose of identifying or inferring emotions or intentions of natural\
        \ persons on the basis of their biometric data;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.41
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.41'
      description: "\u2018biometric categorisation system\u2019 means an AI system\
        \ for the purpose of assigning natural persons to specific categories on the\
        \ basis of their biometric data, unless it is ancillary to another commercial\
        \ service and strictly necessary for objective technical reasons;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.42
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.42'
      description: "\u2018remote biometric identification system\u2019 means an AI\
        \ system for the purpose of identifying natural persons, without their active\
        \ involvement, typically at a distance through the comparison of a person\u2019\
        s biometric data with the biometric data contained in a reference database\
        \ ;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.43
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.43'
      description: "\u2018real-time remote biometric identification system\u2019 means\
        \ a remote biometric identification system whereby the capturing of biometric\
        \ data, the comparison and the identification all occur without a significant\
        \ delay and comprises not only instant identification, but also limited short\
        \ delays in order to avoid circumvention;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.44
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.44'
      description: "\u2018post remote biometric identification system\u2019 means\
        \ a remote biometric identification system other than a real-time remote biometric\
        \ identification system;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.45
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.45'
      description: "\u2018publicly accessible space\u2019 means any publicly or privately\
        \ owned physical place accessible to an undetermined number of natural persons,\
        \ regardless of whether certain conditions for access may apply, and regardless\
        \ of the potential capacity restrictions;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.46
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.46'
      description: "\u2018law enforcement authority\u2019 means:\n(a) any public authority\
        \ competent for the prevention, investigation, detection or prosecution of\
        \ criminal offences or the execution of criminal penalties, including the\
        \ safeguarding against and the prevention of threats to public security; or\n\
        (b) any other body or entity entrusted by Member State law to exercise public\
        \ authority and public powers for the purposes of the prevention, investigation,\
        \ detection or prosecution of criminal offences or the execution of criminal\
        \ penalties, including the safeguarding against and the prevention of threats\
        \ to public security;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.47
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.47'
      description: "\u2018law enforcement\u2019 means activities carried out by law\
        \ enforcement authorities or on their behalf for the prevention, investigation,\
        \ detection or prosecution of criminal offences or the execution of criminal\
        \ penalties, including safeguarding against and preventing threats to public\
        \ security;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.48
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.48'
      description: "\u2018AI Office\u2019 means the Commission\u2019s function of\
        \ contributing to the implementation, monitoring and supervision of AI systems\
        \ and AI governance carried out by the European Artificial Intelligence Office\
        \ established by Commission Decision of 24.1.2024; references in this Regulation\
        \ to the AI Office shall be construed as references to the Commission;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.49
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.49'
      description: "\u2018national competent authority\u2019 means a notifying authority\
        \ or a market surveillance authority;;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.50
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.50'
      description: "\u2018serious incident\u2019 means an incident or malfunctioning\
        \ of an AI system that directly or indirectly leads to any of the following:\n\
        (a) the death of a person, or serious harm to a person\u2019s health;\n(b)\
        \ a serious and irreversible disruption of the management or operation of\
        \ critical\ninfrastructure.\n(c) the infringement of obligations under Union\
        \ law intended to protect fundamental\nrights;\n(d) serious harm to property\
        \ or the environment;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.51
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.51'
      description: "\u2018personal data\u2019 means personal data as defined in Article\
        \ 4, point (1), of Regulation (EU) 2016/679;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.52
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.52'
      description: "\u2018non-personal data\u2019 means data other than personal data\
        \ as defined in Article 4, point (1), of Regulation (EU) 2016/679;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.53
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.53'
      description: "\u2018profiling\u2019 means profiling as defined in Article 4,\
        \ point (4), of Regulation (EU) 2016/679 or, in the case of law enforcement\
        \ authorities, as defined in Article 3, point (4) of Directive (EU) 2016/680\
        \ or, in the case of Union institutions, bodies, offices or agencies, as defined\
        \ in Article 3, point (5) of Regulation (EU) 2018/1725;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.54
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.54'
      description: "\u2018real-world testing plan\u2019 means a document that describes\
        \ the objectives, methodology, geographical, population and temporal scope,\
        \ monitoring, organisation and conduct of testing in real-world conditions;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.55
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.55'
      description: "\u2018sandbox plan\u2019 means a document agreed between the participating\
        \ provider and the competent authority describing the objectives, conditions,\
        \ timeframe, methodology and requirements for the activities carried out within\
        \ the sandbox;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.56
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.56'
      description: "\u2018AI regulatory sandbox\u2019 means a controlled framework\
        \ set up by a competent authority which offers providers or prospective providers\
        \ of AI systems the possibility to develop, train, validate and test, where\
        \ appropriate in real-world conditions, an innovative AI system, pursuant\
        \ to a sandbox plan for a limited time under regulatory supervision;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.57
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.57'
      description: "\u2018AI literacy\u2019 means skills, knowledge and understanding\
        \ that allows providers, deployers and affected persons, taking into account\
        \ their respective rights and obligations in the context of this Regulation,\
        \ to make an informed deployment of AI systems, as well as to gain awareness\
        \ about the opportunities and risks of AI and possible harm it can cause;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.58
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.58'
      description: "\u2018testing in real-world conditions\u2019 means the temporary\
        \ testing of an AI system for its intended purpose in real-world conditions\
        \ outside a laboratory or otherwise simulated environment, with a view to\
        \ gathering reliable and robust data and to assessing and verifying the conformity\
        \ of the AI system with the requirements of this Regulation and it is not\
        \ considered to be placing the AI system on the market or putting it into\
        \ service within the meaning of this Regulation, provided that all the conditions\
        \ laid down in Article 57 or 60 are fulfilled;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.59
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.59'
      description: "\u2018subject\u2019, for the purpose of real-world testing, means\
        \ a natural person who participates in testing in real-world conditions;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.60
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.60'
      description: "\u2018informed consent\u2019 means a subject's freely given, specific,\
        \ unambiguous and voluntary expression of his or her willingness to participate\
        \ in a particular testing in real-world conditions, after having been informed\
        \ of all aspects of the testing that are relevant to the subject's decision\
        \ to participate;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.61
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.61'
      description: "deep fake\u2019 means AI-generated or manipulated image, audio\
        \ or video content that resembles existing persons, objects, places or other\
        \ entities or events and would falsely appear to a person to be authentic\
        \ or truthful;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.62
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.62'
      description: "\u2018widespread infringement\u2019 means any act or omission\
        \ contrary to Union law protecting the interest of individuals, which:\n(a)\
        \ has harmed or is likely to harm the collective interests of individuals\
        \ residing in at least two Member States other than the Member State in which:\n\
        (i) the act or omission originated or took place;\n(b) has caused, causes\
        \ or is likely to cause harm to the collective interests of individuals and\
        \ has common features, including the same unlawful practice or the same interest\
        \ being infringed, and is occurring concurrently, committed by the same operator,\
        \ in at least three Member States;\n(ii) the provider concerned, or, where\
        \ applicable, its authorised representative is located or established; or\n\
        (iii) the deployer is established, when the infringement is committed by the\
        \ deployer;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.63
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.63'
      description: "\u2018critical infrastructure\u2019 means critical infrastructure\
        \ as defined in Article 2, point (4), of Directive (EU) 2022/2557;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.64
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.64'
      description: "\u2018general-purpose AI model\u2019 means an AI model, including\
        \ where such an AI model is trained with a large amount of data using self-supervision\
        \ at scale, that displays significant generality and is capable of competently\
        \ performing a wide range of distinct tasks regardless of the way the model\
        \ is placed on the market and that can be integrated into a variety of downstream\
        \ systems or applications, except AI models that are used for research, development\
        \ or prototyping activities before they are released on the market;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.65
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.65'
      description: "\u2018high-impact capabilities\u2019 means capabilities that match\
        \ or exceed the capabilities recorded in the most advanced general-purpose\
        \ AI models;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.66
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.66'
      description: "\u2018systemic risk\u2019 means a risk that is specific to the\
        \ high-impact capabilities of general- purpose AI models, having a significant\
        \ impact on the Union market due to their reach, or due to actual or reasonably\
        \ foreseeable negative effects on public health, safety, public security,\
        \ fundamental rights, or the society as a whole, that can be propagated at\
        \ scale across the value chain;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.67
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.67'
      description: "\u2018general-purpose AI system\u2019 means an AI system which\
        \ is based on a general-purpose AI model, that has the capability to serve\
        \ a variety of purposes, both for direct use as well as for integration in\
        \ other AI systems;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.68
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.68'
      description: "\u2018floating-point operation\u2019 or \u2018FLOP\u2019 means\
        \ any mathematical operation or assignment involving floating-point numbers,\
        \ which are a subset of the real numbers typically represented on computers\
        \ by an integer of fixed precision scaled by an integer exponent of a fixed\
        \ base;"
    - urn: urn:intuitem:risk:req_node:ai-act:3.69
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:3.1
      ref_id: '3.69'
      description: "\u2018downstream provider\u2019 means a provider of an AI system,\
        \ including a general-purpose AI system, which integrates an AI model, regardless\
        \ of whether the model is provided by themselves and vertically integrated\
        \ or provided by another entity based on contractual relations."
    - urn: urn:intuitem:risk:req_node:ai-act:node270
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node183
      name: 'Article 4 '
      description: AI literacy
    - urn: urn:intuitem:risk:req_node:ai-act:node271
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node270
      description: Providers and deployers of AI systems shall take measures to ensure,
        to their best extent, a sufficient level of AI literacy of their staff and
        other persons dealing with the operation and use of AI systems on their behalf,
        taking into account their technical knowledge, experience, education and training
        and the context the AI systems are to be used in, and considering the persons
        or groups of persons on whom the AI systems are to be used.
    - urn: urn:intuitem:risk:req_node:ai-act:node272
      assessable: false
      depth: 1
      name: CHAPTER II
      description: PROHIBITED ARTIFICIAL INTELLIGENCE PRACTICES
    - urn: urn:intuitem:risk:req_node:ai-act:node273
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node272
      name: Article 5
      description: Prohibited AI Practices
    - urn: urn:intuitem:risk:req_node:ai-act:5.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.1'
      description: 'The following AI practices shall be prohibited: '
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.a
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.a
      description: "the placing on the market, the putting into service or the use\
        \ of an AI system that deploys subliminal techniques beyond a person\u2019\
        s consciousness or purposefully manipulative or deceptive techniques, with\
        \ the objective, or the effect of, materially distorting the behaviour of\
        \ a person or a group of persons by appreciably impairing their ability to\
        \ make an informed decision, thereby causing a person to take a decision that\
        \ that person would not have otherwise taken in a manner that causes or is\
        \ likely to cause that person, another person or group of persons significant\
        \ harm;"
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.b
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.b
      description: the placing on the market, the putting into service or the use
        of an AI system that exploits any of the vulnerabilities of a person or a
        specific group of persons due to their age, disability or a specific social
        or economic situation, with the objective, or the effect, of materially distorting
        the behaviour of that person or a person belonging to that group in a manner
        that causes or is reasonably likely to cause that person or another person
        significant harm;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.c
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.c
      description: 'the placing on the market, the putting into service or the use
        of AI systems  for the purpose of the evaluation or classification of natural
        persons or groups of persons over a certain period of time based on their
        social behaviour or known, inferred or predicted personal or personality characteristics,
        with the social score leading to either or both of the following:'
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.c.i
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1.c
      ref_id: 5.1.c.i
      description: detrimental or unfavourable treatment of certain natural persons
        or whole groups of persons in social contexts that are unrelated to the contexts
        in which the data was originally generated or collected;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.c.ii
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1.c
      ref_id: 5.1.c.ii
      description: detrimental or unfavourable treatment of certain natural persons
        or  groups of persons that is unjustified or disproportionate to their social
        behaviour or its gravity;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.d
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.d
      description: the placing on the market, the putting into service for this specific
        purpose, or the use of an AI system for making risk assessments of natural
        persons in order to assess or predict the likelihood of a natural person committing
        a criminal offence, based solely on the profiling of a natural person or on
        assessing their personality traits and characteristics; this prohibition shall
        not apply to AI systems used to support the human assessment of the involvement
        of a person in a criminal activity, which is already based on objective and
        verifiable facts directly linked to a criminal activity
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.e
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.e
      description: the placing on the market, the putting into service for this specific
        purpose, or use of AI systems that create or expand facial recognition databases
        through the untargeted scraping of facial images from the internet or CCTV
        footage;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.f
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.f
      description: the placing on the market, the putting into service for this specific
        purpose, or the use of AI systems to infer emotions of a natural person in
        the areas of workplace and education institutions, except where the use of
        the AI system is intended to be put in place or into the market for medical
        or safety reasons.
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.g
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.g
      description: the placing on the market, the putting into service for this specific
        purpose, or the use of biometric categorisation systems that categorise individually
        natural persons based on their biometric data to deduce or infer their race,
        political opinions, trade union membership, religious or philosophical beliefs,
        sex life or sexual orientation; this prohibition does not cover any labelling
        or filtering of lawfully acquired biometric datasets, such as images, based
        on biometric data or categorizing of biometric data in the area of law enforcement;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.h
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1
      ref_id: 5.1.h
      description: "the use of \u2018real-time\u2019 remote biometric identification\
        \ systems in publicly accessible spaces for the purposes of law enforcement,\
        \  unless and in so far as such use is strictly necessary for one of the following\
        \ objectives:"
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.h.i
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1.h
      ref_id: 5.1.h.i
      description: the targeted search for specific  victims of abduction, trafficking
        in human beings or sexual exploitation of human beings, as well as searching
        for missing persons;
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.h.ii
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1.h
      ref_id: 5.1.h.ii
      description: 'the prevention of a specific, substantial and imminent threat
        to the life or physical safety of natural persons or a genuine and present
        or genuine and foreseeable threat of a terrorist attack;

        '
    - urn: urn:intuitem:risk:req_node:ai-act:5.1.h.iii
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.1.h
      ref_id: 5.1.h.iii
      description: the localisation or identification of a person suspected of having
        committed a criminal offence, for the purpose of conducting a criminal investigation,
        prosecution or executing a criminal penalty for offences referred to in Annex
        II and punishable in the Member State concerned by a custodial sentence or
        a detention order for a maximum period of at least four years;
    - urn: urn:intuitem:risk:req_node:ai-act:node288
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      description: Point (h) of the first subparagraph is without prejudice to Article
        9 of Regulation (EU) 2016/679 for the processing of biometric data for purposes
        other than law enforcement.
    - urn: urn:intuitem:risk:req_node:ai-act:5.2
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.2'
      description: "The use of \u2018real-time\u2019 remote biometric identification\
        \ systems in publicly accessible spaces for the purposes of law enforcement\
        \ for any of the objectives referred to in paragraph 1, point (h), shall be\
        \ deployed only for the purposes set out in paragraph 1, point (h), to confirm\
        \ the identity of the specifically targeted individual, and it shall take\
        \ into account the following elements:"
    - urn: urn:intuitem:risk:req_node:ai-act:5.2.a
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.2
      ref_id: 5.2.a
      description: the nature of the situation giving rise to the possible use, in
        particular the seriousness, probability and scale of the harm that would be
        caused if the system were not used;
    - urn: urn:intuitem:risk:req_node:ai-act:5.2.b
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:5.2
      ref_id: 5.2.b
      description: the consequences of the use of the system for the rights and freedoms
        of all persons concerned, in particular the seriousness, probability and scale
        of those consequences.
    - urn: urn:intuitem:risk:req_node:ai-act:node292
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      description: "In addition, the use of \u2018real-time\u2019 remote biometric\
        \ identification systems in publicly accessible spaces for the purposes of\
        \ law enforcement for any of the objectives referred to in paragraph 1, point\
        \ (h), of this Article shall comply with necessary and proportionate safeguards\
        \ and conditions in relation to the use in accordance with national law authorising\
        \ the use thereof, in particular as regards the temporal, geographic and personal\
        \ limitations. The use of the \u2018real-time\u2019 remote biometric identification\
        \ system in publicly accessible spaces shall be authorised only if the law\
        \ enforcement authority has completed a fundamental rights impact assessment\
        \ as provided for in Article 27 and has registered the system in the EU database\
        \ according to Article 49. However, in duly justified cases of urgency, the\
        \ use of such systems may be commenced without the registration in the EU\
        \ database, provided that such registration is completed without undue delay."
    - urn: urn:intuitem:risk:req_node:ai-act:5.3
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.3'
      description: "For the purposes of paragraph 1, point (h) and paragraph 2, each\
        \  use for the purposes of law enforcement of a \u2018real-time\u2019 remote\
        \ biometric identification system in publicly accessible spaces shall be subject\
        \ to a prior authorisation granted by a judicial authority or  an independent\
        \ administrative authority whose decision is binding of the Member State in\
        \ which the use is to take place, issued upon a reasoned request and in accordance\
        \ with the detailed rules of national law referred to in paragraph 5. However,\
        \ in a duly justified situation of urgency, the use of such system may be\
        \ commenced without an authorisation provided that such authorisation is requested\
        \ without undue delay, at the latest within 24 hours. If such authorisation\
        \ is rejected, the use shall be stopped with immediate effect and all the\
        \ data, as well as the results and outputs of that use shall be immediately\
        \ discarded and deleted."
    - urn: urn:intuitem:risk:req_node:ai-act:node294
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      description: "The competent judicial authority or an independent administrative\
        \ authority whose decision is binding shall grant the authorisation only where\
        \ it is satisfied, on the basis of objective evidence or clear indications\
        \ presented to it, that the use of the \u2018real-time\u2019 remote biometric\
        \ identification system concerned is necessary for, and proportionate to,\
        \ achieving one of the objectives specified in paragraph 1, point (h), as\
        \ identified in the request and, in particular, remains limited to what is\
        \ strictly necessary concerning the period of time as well as the geographic\
        \ and personal scope. In deciding on the request, that authority shall take\
        \ into account the elements referred to in paragraph 2. No decision that produces\
        \ an adverse legal effect on a person may be taken based solely on the output\
        \ of the \u2018real- time\u2019 remote biometric identification system."
    - urn: urn:intuitem:risk:req_node:ai-act:5.4
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.4'
      description: "Without prejudice to paragraph 3, each use of a \u2018real-time\u2019\
        \ remote biometric identification system in publicly accessible spaces for\
        \ law enforcement purposes shall be notified to the relevant market surveillance\
        \ authority and the national data protection authority in accordance with\
        \ the national rules referred to in paragraph 5. The notification shall, as\
        \ a minimum, contain the information specified under paragraph 6 and shall\
        \ not include sensitive operational data."
    - urn: urn:intuitem:risk:req_node:ai-act:5.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.5'
      description: "A Member State may decide to provide for the possibility to fully\
        \ or partially authorise the use of \u2018real-time\u2019 remote biometric\
        \ identification systems in publicly accessible spaces for the purposes of\
        \ law enforcement within the limits and under the conditions listed in paragraph\
        \ 1, point (h), and paragraphs 2 and 3.  Member States concerned shall lay\
        \ down in their national law the necessary detailed rules for the request,\
        \ issuance and exercise of, as well as supervision and reporting relating\
        \ to, the authorisations referred to in paragraph 3. Those rules shall also\
        \ specify in respect of which of the objectives listed in paragraph 1, point\
        \ (h), including which of the criminal offences referred to in point (h)(iii)\
        \ thereof, the competent authorities may be authorised to use those systems\
        \ for the purposes of law enforcement. Member States shall notify those rules\
        \ to the Commission at the latest 30 days following the adoption thereof.\
        \ Member States may introduce, in accordance with Union law, more restrictive\
        \ laws on the use of remote biometric identification systems."
    - urn: urn:intuitem:risk:req_node:ai-act:5.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.6'
      description: "National market surveillance authorities and the national data\
        \ protection authorities of Member States that have been notified of the use\
        \ of \u2018real-time\u2019 remote biometric identification systems in publicly\
        \ accessible spaces for law enforcement purposes pursuant to paragraph 4 shall\
        \ submit to the Commission annual reports on such use. For that purpose, the\
        \ Commission shall provide Member States and national market surveillance\
        \ and data protection authorities with a template, including information on\
        \ the number of the decisions taken by competent judicial authorities or an\
        \ independent administrative authority whose decision is binding upon requests\
        \ for authorisations in accordance with paragraph 3 and their result."
    - urn: urn:intuitem:risk:req_node:ai-act:5.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.7'
      description: The Commission shall publish annual reports on the use of real-time
        remote biometric identification systems in publicly accessible spaces for
        law enforcement purposes, based on aggregated data in Member States on the
        basis of the annual reports referred to in paragraph 6. Those annual reports
        shall not include sensitive operational data of the related law enforcement
        activities.
    - urn: urn:intuitem:risk:req_node:ai-act:5.8
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node273
      ref_id: '5.8'
      description: This Article shall not affect the prohibitions that apply where
        an AI practice infringes other Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:node300
      assessable: false
      depth: 1
      name: 'CHAPTER III '
      description: HIGH-RISK AI SYSTEMS
    - urn: urn:intuitem:risk:req_node:ai-act:node301
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node300
      name: Section 1
      description: Classification of AI systems as high-risk
    - urn: urn:intuitem:risk:req_node:ai-act:node302
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node301
      name: Article 6
      description: Classification rules for high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:6.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.1'
      description: 'Irrespective of whether an AI system is placed on the market or
        put into service independently from the products referred to in points (a)
        and (b), that AI system shall be considered to be high-risk where both of
        the following conditions are fulfilled:'
    - urn: urn:intuitem:risk:req_node:ai-act:6.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.1
      ref_id: 6.1.a
      description: the AI system is intended to be used as a safety component of a
        product, or the AI system is itself a product, covered by the Union harmonisation
        legislation listed in Annex I;
    - urn: urn:intuitem:risk:req_node:ai-act:6.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.1
      ref_id: 6.1.b
      description: the product whose safety component pursuant to point (a) is the
        AI system, or the AI system itself as a product, is required to undergo a
        third-party conformity assessment, with a view to the placing on the market
        or the putting into service of that product pursuant to the Union harmonisation
        legislation listed in Annex I.
    - urn: urn:intuitem:risk:req_node:ai-act:6.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.2'
      description: In addition to the high-risk AI systems referred to in paragraph
        1, AI systems referred to in Annex III shall be considered to be high-risk.
    - urn: urn:intuitem:risk:req_node:ai-act:6.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.3'
      description: 'By derogation from paragraph 2, an AI system shall not be considered
        to be high-risk if it does not pose a significant risk of harm to the health,
        safety or fundamental rights of natural persons, including by not materially
        influencing the outcome of decision making. This shall be the case where one
        or more of the following conditions are fulfilled:'
    - urn: urn:intuitem:risk:req_node:ai-act:6.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.3
      ref_id: 6.3.a
      description: the AI system is intended to perform a narrow procedural task;
    - urn: urn:intuitem:risk:req_node:ai-act:6.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.3
      ref_id: 6.3.b
      description: the AI system is intended to improve the result of a previously
        completed human activity;
    - urn: urn:intuitem:risk:req_node:ai-act:6.3.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.3
      ref_id: 6.3.c
      description: the AI system is intended to detect decision-making patterns or
        deviations from prior decision-making patterns and is not meant to replace
        or influence the previously completed human assessment, without proper human
        review; or
    - urn: urn:intuitem:risk:req_node:ai-act:6.3.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:6.3
      ref_id: 6.3.d
      description: the AI system is intended to perform a preparatory task to an assessment
        relevant for the purposes of the use cases listed in Annex III.
    - urn: urn:intuitem:risk:req_node:ai-act:node312
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      description: Notwithstanding the first subparagraph, an AI system referred to
        in Annex III shall always be considered to be high-risk where the AI system
        performs profiling of natural persons.
    - urn: urn:intuitem:risk:req_node:ai-act:6.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.4'
      description: 'A provider who considers that an AI system referred to in Annex
        III is not high-risk shall document its assessment before that system is placed
        on the market or put into service. Such provider shall be subject to the registration
        obligation set out in

        Article 49(2). Upon request of national competent authorities, the provider
        shall provide the documentation of the assessment.'
    - urn: urn:intuitem:risk:req_node:ai-act:6.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.5'
      description: "The Commission shall, after consulting the European Artificial\
        \ Intelligence Board (the \u2018Board\u2019), and no later than 2 February\
        \ 2026, provide guidelines specifying the practical implementation of this\
        \ Article in line with Article 96 together with a comprehensive list of practical\
        \ examples of use cases of AI systems that are high-risk and not high-risk."
    - urn: urn:intuitem:risk:req_node:ai-act:6.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node302
      ref_id: '6.6'
      description: 'The Commission shall adopt delegated acts in accordance with Article
        97 to amend the conditions laid down in paragraph 3, first subparagraph, of
        this Article.

        The Commission may adopt delegated acts in accordance with Article 97 in order
        to add new conditions to those laid down in paragraph 3, first subparagraph,
        or to modify them, only where there is concrete and reliable evidence of the
        existence of AI systems that fall under the scope of Annex III but do not
        pose a significant risk of harm to the health, safety or fundamental rights
        of natural persons.

        The Commission shall adopt delegated acts in accordance with Article 97 in
        order to delete any of the conditions laid down in the paragraph 3, first
        subparagraph, where there is concrete and reliable evidence that this is necessary
        for the purpose of maintaining the level of protection of health, safety and
        fundamental rights in the Union.

        Any amendment to the conditions laid down in paragraph 3, first subparagraph,
        shall not decrease the overall level of protection of health, safety and fundamental
        rights in the Union.

        When adopting the delegated acts, the Commission shall ensure consistency
        with the delegated acts adopted pursuant to Article 7(1), and shall take account
        of market and technological developments.'
    - urn: urn:intuitem:risk:req_node:ai-act:node316
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node301
      name: Article 7
      description: Amendments to Annex III
    - urn: urn:intuitem:risk:req_node:ai-act:7.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node316
      ref_id: '7.1'
      description: 'The Commission shall adopt delegated acts in accordance with Article
        97 to amend Annex III by adding or modifying use-cases of high-risk AI systems
        where both of the following conditions are fulfilled:

        (a) the AI systems are intended to be used in any of the areas listed in Annex
        III;

        (b) the AI systems pose a risk of harm to  health and safety, or an adverse
        impact on fundamental rights, and that risk is equivalent to, or greater than,
        the risk of harm or of adverse impact posed by the high-risk AI systems already
        referred to in Annex III.'
    - urn: urn:intuitem:risk:req_node:ai-act:7.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node316
      ref_id: '7.2'
      description: 'When assessing the condition under paragraph 1, point (b),, the
        Commission shall take into account the following criteria:

        (a)the intended purpose of the AI system;

        (b)the extent to which an AI system has been used or is likely to be used;

        (c)the nature and amount of the data processed and used by the AI system,
        in particular whether special categories of personal data are processed;

        (d)the extent to which the AI system acts autonomously and the possibility
        for a human to override a decision or recommendations that may lead to potential
        harm;

        (e) the extent to which the use of an AI system has already caused harm to  health
        and safety, has had an adverse impact on  fundamental rights or has given
        rise to significant concerns in relation to the likelihood of such harm or
        adverse impact, as demonstrated, for example, by reports or documented allegations
        submitted to national competent authorities or by other reports, as appropriate;

        (f) the potential extent of such harm or such adverse impact, in particular
        in terms of its intensity and its ability to affect multiple persons or to
        disproportionately affect a particular group of persons;

        (g) the extent to which persons who are potentially harmed or suffer an adverse
        impact are dependent on the outcome produced with an AI system, in particular
        because for practical or legal reasons it is not reasonably possible to opt-out
        from that outcome;

        (h) the extent to which there is an imbalance of power, or the persons who
        are potentially harmed or suffer an adverse impact are in a vulnerable position
        in relation to the deployer of an AI system, in particular due to status,
        authority, knowledge, economic or social circumstances, or age;

        (i) the extent to which the outcome produced involving an AI system is easily
        corrigible or reversible, taking into account the technical solutions available
        to correct or reverse it, whereby outcomes having an adverse impact on health,
        safety or fundamental rights, shall not be considered to be easily corrigible
        or reversible;

        (j) the magnitude and likelihood of benefit of the deployment of the AI system
        for individuals, groups, or society at large, including possible improvements
        in product safety;

        (k) the extent to which existing Union law provides for:

        (i) effective measures of redress in relation to the risks posed by an AI
        system, with the exclusion of claims for damages;

        (ii) effective measures to prevent or substantially minimise those risks.'
    - urn: urn:intuitem:risk:req_node:ai-act:7.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node316
      ref_id: '7.3'
      description: 'The Commission shall adopt delegated acts in accordance with Article
        97 to amend the list in Annex III by removing high-risk AI systems where both
        of the following conditions are fulfilled:

        (a) the high-risk AI system concerned no longer poses any significant risks
        to fundamental rights, health or safety, taking into account the criteria
        listed in paragraph 2;

        (b) the deletion does not decrease the overall level of protection of health,
        safety and fundamental rights under Union law.'
    - urn: urn:intuitem:risk:req_node:ai-act:node320
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node300
      name: Section 2
      description: Requirements for high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:node321
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 8
      description: Compliance with the requirements
    - urn: urn:intuitem:risk:req_node:ai-act:8.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node321
      ref_id: '8.1'
      description: High-risk AI systems shall comply with the requirements laid down
        in this Section, taking into account their intended purposes as well as the
        generally acknowledged state of the art on AI and AI-related technologies.
        The risk management system referred to in Article 9 shall be taken into account
        when ensuring compliance with those requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:8.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node321
      ref_id: '8.2'
      description: Where a product contains an AI system, to which the requirements
        of this Regulation as well as requirements of the Union harmonisation legislation
        listed in Section A of Annex I apply, providers shall be responsible for ensuring
        that their product is fully compliant with all applicable requirements required
        under applicable Union harmonisation legislation. In ensuring the compliance
        of high-risk AI systems referred to in paragraph 1 with the requirements set
        out in this Section, and in order to ensure consistency, avoid duplications
        and minimise additional burdens, providers shall have a choice of integrating,
        as appropriate, the necessary testing and reporting processes, information
        and documentation they provide with regard to their product into documentation
        and procedures that already exist and are required under the Union harmonisation
        legislation listed in Section A of Annex I,.
    - urn: urn:intuitem:risk:req_node:ai-act:node324
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 9
      description: Risk management system
    - urn: urn:intuitem:risk:req_node:ai-act:9.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.1'
      description: A risk management system shall be established, implemented, documented
        and maintained in relation to high-risk AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:9.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.2'
      description: 'The risk management system shall be understood as a continuous
        iterative process planned and run throughout the entire lifecycle of a high-risk
        AI system, requiring regular systematic review and updating. It shall comprise
        the following steps:'
    - urn: urn:intuitem:risk:req_node:ai-act:9.2.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.2
      ref_id: 9.2.a
      description: the identification and analysis of the known and the reasonably
        foreseeable risks that the high-risk AI system can pose to health, safety
        or fundamental rights when the high-risk AI system is used in accordance with
        its intended purpose;
    - urn: urn:intuitem:risk:req_node:ai-act:9.2.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.2
      ref_id: 9.2.b
      description: the estimation and evaluation of the risks that may emerge when
        the high-risk AI system is used in accordance with its intended purpose, and
        under conditions of reasonably foreseeable misuse;
    - urn: urn:intuitem:risk:req_node:ai-act:9.2.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.2
      ref_id: 9.2.c
      description: the evaluation of other risks possibly arising, based on the analysis
        of data gathered from the post-market monitoring system referred to in Article
        72;
    - urn: urn:intuitem:risk:req_node:ai-act:9.2.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.2
      ref_id: 9.2.d
      description: the adoption of appropriate and targeted risk management measures
        designed to address the risks identified pursuant to point (a) .
    - urn: urn:intuitem:risk:req_node:ai-act:9.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.3'
      description: The risks referred to in this Article shall concern only those
        which may be reasonably mitigated or eliminated through the development or
        design of the high-risk AI system, or the provision of adequate technical
        information.
    - urn: urn:intuitem:risk:req_node:ai-act:9.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.4'
      description: The risk management measures referred to in paragraph 2, point
        (d), shall give due consideration to the effects and possible interaction
        resulting from the combined application of the requirements set out in this
        Section, with a view to minimising risks more effectively while achieving
        an appropriate balance in implementing the measures to fulfil those requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:9.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.5'
      description: 'The risk management measures referred to in paragraph 2, point
        (d), shall be such that the relevant residual risk associated with each hazard,
        as well as the overall residual risk of the high-risk AI systems is judged
        to be acceptable.In identifying the most appropriate risk management measures,
        the following shall be ensured:'
    - urn: urn:intuitem:risk:req_node:ai-act:9.5.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.5
      ref_id: 9.5.a
      description: elimination or reduction of identified and evaluated risks pursuant
        to paragraph 2 as far as technically feasible through adequate design and
        development of the high- risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:9.5.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.5
      ref_id: 9.5.b
      description: where appropriate, implementation of adequate mitigation and control
        measures addressing risks that cannot be eliminated;
    - urn: urn:intuitem:risk:req_node:ai-act:9.5.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:9.5
      ref_id: 9.5.c
      description: 'provision of information required pursuant to Article 13 and,
        where appropriate, training to deployers. '
    - urn: urn:intuitem:risk:req_node:ai-act:node337
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      description: With a view to eliminating or reducing risks related to the use
        of the high-risk AI system, due consideration shall be given to the technical
        knowledge, experience, education, the training to be expected by the deployer,
        and the presumable context in which the system is intended to be used.
    - urn: urn:intuitem:risk:req_node:ai-act:9.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.6'
      description: High-risk AI systems shall be tested for the purpose of identifying
        the most appropriate and targeted risk management measures. Testing shall
        ensure that high-risk AI systems perform consistently for their intended purpose
        and that they are in compliance with the requirements set out in this Section.
    - urn: urn:intuitem:risk:req_node:ai-act:9.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.7'
      description: Testing procedures may include testing in real-world conditions
        in accordance with Article 60.
    - urn: urn:intuitem:risk:req_node:ai-act:9.8
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.8'
      description: The testing of high-risk AI systems shall be performed, as appropriate,
        at any time throughout the development process, and, in any event, prior to
        their being placed on the market or put into service. Testing shall be carried
        out against prior defined metrics and probabilistic thresholds that are appropriate
        to the intended purpose of the high-risk AI system.
    - urn: urn:intuitem:risk:req_node:ai-act:9.9
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.9'
      description: When implementing the risk management system as provided for in
        paragraphs 1 to 7, providers shall give consideration to whether in view of
        its intended purpose the high-risk AI system is likely to have an adverse
        impact on persons under the age of 18 and, as appropriate, other groups of
        vulnerable persons.
    - urn: urn:intuitem:risk:req_node:ai-act:9.10
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node324
      ref_id: '9.10'
      description: For providers of high-risk AI systems that are subject to requirements
        regarding internal risk management processes under other relevant provisions
        of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or
        combined with, the risk management procedures established pursuant to that
        law.
    - urn: urn:intuitem:risk:req_node:ai-act:node343
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 10
      description: Data and data governance
    - urn: urn:intuitem:risk:req_node:ai-act:10.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.1'
      description: High-risk AI systems which make use of techniques involving the
        training of AI models with data shall be developed on the basis of training,
        validation and testing data sets that meet the quality criteria referred to
        in paragraphs 2 to 5 whenever such data sets are used.
    - urn: urn:intuitem:risk:req_node:ai-act:10.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.2'
      description: 'Training, validation and testing data sets shall be subject to
        data governance and management practices appropriate for the intended purpose
        of the high-risk AI system. Those practices shall concern in particular:'
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.a
      description: the relevant design choices;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.b
      description: data collection processes and the origin of data, and in the case
        of personal data, the original purpose of the data collection;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.c
      description: relevant data-preparation processing operations, such as annotation,
        labelling, cleaning, updating, enrichment and aggregation;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.d
      description: the formulation of  assumptions, in particular with respect to
        the information that the data are supposed to measure and represent;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.e
      description: an assessment of the availability, quantity and suitability of
        the data sets that are needed;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.f
      description: examination in view of possible biases that are likely to affect
        the health and safety of persons, have a negative impact on fundamental rights
        or lead to discrimination prohibited under Union law, especially where data
        outputs influence inputs for future operations;
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.g
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.g
      description: appropriate measures to detect, prevent and mitigate possible biases
        identified according to point (f);
    - urn: urn:intuitem:risk:req_node:ai-act:10.2.h
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.2
      ref_id: 10.2.h
      description: the identification of relevant data gaps or shortcomings that prevent
        compliance with this Regulation, and how those gaps and shortcomings can be
        addressed.
    - urn: urn:intuitem:risk:req_node:ai-act:10.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.3'
      description: Training, validation and testing data sets shall be relevant, sufficiently
        representative, and to the best extent possible, free of errors and complete
        in view of the intended purpose. They shall have the appropriate statistical
        properties, including, where applicable, as regards the persons or groups
        of persons in relation to whom the high-risk AI system is intended to be used.
        Those characteristics of the data sets may be met at the level of individual
        data sets or at the level of a combination thereof.
    - urn: urn:intuitem:risk:req_node:ai-act:10.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.4'
      description: Data sets shall take into account, to the extent required by the
        intended purpose, the characteristics or elements that are particular to the
        specific geographical, contextual, behavioural or functional setting within
        which the high-risk AI system is intended to be used.
    - urn: urn:intuitem:risk:req_node:ai-act:10.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.5'
      description: 'To the extent that it is strictly necessary for the purpose of
        ensuring bias detection and correction in relation to the high-risk AI systems
        in accordance with paragraph (2), points (f) and (g) of this Article, the
        providers of such systems may exceptionally process special categories of
        personal data, subject to appropriate safeguards for the fundamental rights
        and freedoms of natural persons. In addition to the provisions set out in
        Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725,
        all the following conditions shall apply in order for such processing to occur:'
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.a
      description: the bias detection and correction cannot be effectively fulfilled
        by processing other data, including synthetic or anonymised data;
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.b
      description: the special categories of personal data are subject to technical
        limitations on the re-use of the personal data, and state of the art security
        and privacy-preserving measures, including pseudonymisation;
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.c
      description: the special categories of personal data are subject to measures
        to ensure that the personal data processed are secured, protected, subject
        to suitable safeguards, including strict controls and documentation of the
        access, to avoid misuse and ensure that only authorised persons with appropriate
        confidentiality obligations have access to those personal data;
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.d
      description: the personal data in the special categories of personal data are
        not to be transmitted, transferred or otherwise accessed by other parties;
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.e
      description: the personal data in the special categories of personal data are
        deleted once the bias has been corrected or the personal data has reached
        the end of its retention period, whichever comes first;
    - urn: urn:intuitem:risk:req_node:ai-act:10.5.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:10.5
      ref_id: 10.5.f
      description: the records of processing activities pursuant to Regulations (EU)
        2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680include the reasons
        why the processing of special categories of personal data was strictly necessary
        to detect and correct biases, and why that objective could not be achieved
        by processing other data.
    - urn: urn:intuitem:risk:req_node:ai-act:10.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node343
      ref_id: '10.6'
      description: For the development of high-risk AI systems not using techniques
        involving the training of AI models, paragraphs 2 to 5 apply only to the testing
        data sets.
    - urn: urn:intuitem:risk:req_node:ai-act:node364
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 11
      description: Technical documentation
    - urn: urn:intuitem:risk:req_node:ai-act:11.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node364
      ref_id: '11.1'
      description: 'The technical documentation of a high-risk AI system shall be
        drawn up before that system is placed on the market or put into service and
        shall be kept up-to date.

        The technical documentation shall be drawn up in such a way as to demonstrate
        that the high-risk AI system complies with the requirements set out in this
        Section and to provide national competent authorities and notified bodies
        with the necessary information in a clear and comprehensive form to assess
        the compliance of the AI system with those requirements. It shall contain,
        at a minimum, the elements set out in Annex IV. SMEs, including start-ups,
        may provide the elements of the technical documentation specified in Annex
        IV in a simplified manner. For this purpose, the Commission shall establish
        a simplified technical documentation form targeted at the needs of small and
        microenterprises. Where an SME, including a start-up, opts to provide the
        information required in Annex IV in a simplified manner, it shall use the
        form referred to in this paragraph. Notified bodies shall accept the form
        for the purposes of the conformity assessment.'
    - urn: urn:intuitem:risk:req_node:ai-act:11.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node364
      ref_id: '11.2'
      description: Where a high-risk AI system related to a product covered by the
        Union harmonisation legislation listed in Section A of Annex I is placed on
        the market or put into service, a single set of technical documentation shall
        be drawn up containing all the information set out in paragraph 1, as well
        as the information required under those legal acts.
    - urn: urn:intuitem:risk:req_node:ai-act:11.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node364
      ref_id: '11.3'
      description: The Commission shall adopt delegated acts in accordance with Article
        97 to amend Annex IV where necessary to ensure that, in the light of technical
        progress, the technical documentation provides all the information necessary
        to assess the compliance of the system with the requirements set out in this
        Section.
    - urn: urn:intuitem:risk:req_node:ai-act:node368
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 12
      description: Record-keeping
    - urn: urn:intuitem:risk:req_node:ai-act:12.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node368
      ref_id: '12.1'
      description: "High-risk AI systems shall technically allow for the automatic\
        \ recording of events (\u2018logs\u2019) over their lifetime."
    - urn: urn:intuitem:risk:req_node:ai-act:12.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node368
      ref_id: '12.2'
      description: 'In order to ensure a level of traceability of the functioning
        of a high-risk AI system  that is appropriate to the intended purpose of the
        system, logging capabilities shall enable the recording of events relevant
        for:'
    - urn: urn:intuitem:risk:req_node:ai-act:12.2.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.2
      ref_id: 12.2.a
      description: identifying situations that may result in the high-risk AI system
        presenting a risk within the meaning of Article 79(1) or in a substantial
        modification;
    - urn: urn:intuitem:risk:req_node:ai-act:12.2.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.2
      ref_id: 12.2.b
      description: facilitating the post-market monitoring referred to in Article
        72; and
    - urn: urn:intuitem:risk:req_node:ai-act:12.2.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.2
      ref_id: 12.2.c
      description: monitoring the operation of high-risk AI systems referred to in
        Article 26(6).
    - urn: urn:intuitem:risk:req_node:ai-act:12.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node368
      ref_id: '12.3'
      description: 'For high-risk AI systems referred to in point 1 (a) of Annex III,
        the logging capabilities shall provide, at a minimum:'
    - urn: urn:intuitem:risk:req_node:ai-act:12.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.3
      ref_id: 12.3.a
      description: recording of the period of each use of the system (start date and
        time and end date and time of each use);
    - urn: urn:intuitem:risk:req_node:ai-act:12.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.3
      ref_id: 12.3.b
      description: the reference database against which input data has been checked
        by the system;
    - urn: urn:intuitem:risk:req_node:ai-act:12.3.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.3
      ref_id: 12.3.c
      description: the input data for which the search has led to a match;
    - urn: urn:intuitem:risk:req_node:ai-act:12.3.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:12.3
      ref_id: 12.3.d
      description: the identification of the natural persons involved in the verification
        of the results, as referred to in Article 14(5).
    - urn: urn:intuitem:risk:req_node:ai-act:node379
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 13
      description: Transparency and provision of information to deployers
    - urn: urn:intuitem:risk:req_node:ai-act:13.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node379
      ref_id: '13.1'
      description: "High-risk AI systems shall be designed and developed in such a\
        \ way as to ensure that their operation is sufficiently transparent to enable\
        \ deployers to interpret a system\u2019s output and use it appropriately.\
        \ An appropriate type and degree of transparency shall be ensured with a view\
        \ to achieving compliance with the relevant obligations of the provider and\
        \ deployer set out in Section 3."
    - urn: urn:intuitem:risk:req_node:ai-act:13.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node379
      ref_id: '13.2'
      description: High-risk AI systems shall be accompanied by instructions for use
        in an appropriate digital format or otherwise that include concise, complete,
        correct and clear information that is relevant, accessible and comprehensible
        to deployers.
    - urn: urn:intuitem:risk:req_node:ai-act:13.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node379
      ref_id: '13.3'
      description: 'The instructions for use shall contain at least the following
        information:'
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.a
      description: the identity and the contact details of the provider and, where
        applicable, of its authorised representative;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.b
      description: 'the characteristics, capabilities and limitations of performance
        of the high-risk AI system, including:'
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.i
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.i
      description: its intended purpose;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.ii
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.ii
      description: the level of accuracy, including its metrics, robustness and cybersecurity
        referred to in Article 15 against which the high-risk AI system has been tested
        and validated and which can be expected, and any known and foreseeable circumstances
        that may have an impact on that expected level of accuracy, robustness and
        cybersecurity;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.iii
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.iii
      description: any known or foreseeable circumstance, related to the use of the
        high-risk AI system in accordance with its intended purpose or under conditions
        of reasonably foreseeable misuse, which may lead to risks to the health and
        safety or fundamental rights referred to in Article 9(2);
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.iv
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.iv
      description: where applicable, the technical capabilities and characteristics
        of the high- risk AI system to provide information that is relevant to explain
        its output;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.v
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.v
      description: when appropriate, its performance regarding specific persons or
        groups of persons on which the system is intended to be used;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.vi
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.vi
      description: when appropriate, specifications for the input data, or any other
        relevant information in terms of the training, validation and testing data
        sets used, taking into account the intended purpose of the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.b.vii
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3.b
      ref_id: 13.3.b.vii
      description: where applicable, information to enable deployers to interpret
        the output of the high-risk AI system and use it appropriately;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.c
      description: the changes to the high-risk AI system and its performance which
        have been pre- determined by the provider at the moment of the initial conformity
        assessment, if any;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.d
      description: the human oversight measures referred to in Article 14, including
        the technical measures put in place to facilitate the interpretation of the
        outputs of the high-risk AI systems by the deployers;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.e
      description: the computational and hardware resources needed, the expected lifetime
        of the high-risk AI system and any necessary maintenance and care measures,
        including their frequency, to ensure the proper functioning of that AI system,
        including as regards software updates;
    - urn: urn:intuitem:risk:req_node:ai-act:13.3.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:13.3
      ref_id: 13.3.f
      description: where relevant, a description of the mechanisms included within
        the high-risk AI system that allows deployers to properly collect, store and
        interpret the logs in accordance with Article 12.
    - urn: urn:intuitem:risk:req_node:ai-act:node396
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 14
      description: Human oversight
    - urn: urn:intuitem:risk:req_node:ai-act:14.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      ref_id: '14.1'
      description: High-risk AI systems shall be designed and developed in such a
        way, including with appropriate human-machine interface tools, that they can
        be effectively overseen by natural persons during the period in which they
        are in use.
    - urn: urn:intuitem:risk:req_node:ai-act:14.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      ref_id: '14.2'
      description: Human oversight shall aim to prevent or minimise the risks to health,
        safety or fundamental rights that may emerge when a high-risk AI system is
        used in accordance with its intended purpose or under conditions of reasonably
        foreseeable misuse, in particular where such risks persist despite the application
        of other requirements set out in this Section
    - urn: urn:intuitem:risk:req_node:ai-act:14.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      ref_id: '14.3'
      description: 'The oversight measures shall be commensurate to the risks, level
        of autonomy and context of use of the high-risk AI system, and shall be ensured
        through either one or both of the following types of measures:'
    - urn: urn:intuitem:risk:req_node:ai-act:14.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.3
      ref_id: 14.3.b
      description: measures identified and built, when technically feasible, into
        the high-risk AI system by the provider before it is placed on the market
        or put into service;
    - urn: urn:intuitem:risk:req_node:ai-act:14.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.3
      ref_id: 14.3.a
      description: measures identified by the provider before placing the high-risk
        AI system on the market or putting it into service and that are appropriate
        to be implemented by the deployer.
    - urn: urn:intuitem:risk:req_node:ai-act:14.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      ref_id: '14.4'
      description: 'For the purpose of implementing paragraphs 1, 2 and 3, the high-risk
        AI system shall be provided to the user in such a way that natural persons
        to whom human oversight is assigned are enabled, as appropriate and proportionate
        to the following circumstances:'
    - urn: urn:intuitem:risk:req_node:ai-act:14.4.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.4
      ref_id: 14.4.a
      description: to properly understand the relevant capacities and limitations
        of the high-risk AI system and be able to duly monitor its operation, including
        in view of detecting and addressing anomalies, dysfunctions and unexpected
        performance ;
    - urn: urn:intuitem:risk:req_node:ai-act:14.4.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.4
      ref_id: 14.4.b
      description: "to remain aware of the possible tendency of automatically relying\
        \ or over-relying on the output produced by a high-risk AI system (\u2018\
        automation bias\u2019), in particular for high-risk AI systems used to provide\
        \ information or recommendations for decisions to be taken by natural persons;"
    - urn: urn:intuitem:risk:req_node:ai-act:14.4.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.4
      ref_id: 14.4.c
      description: "to correctly interpret the high-risk AI system\u2019s output,\
        \ taking into account, for example, the interpretation tools and methods available;"
    - urn: urn:intuitem:risk:req_node:ai-act:14.4.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.4
      ref_id: 14.4.d
      description: to decide, in any particular situation, not to use the high-risk
        AI system or to otherwise disregard, override or reverse the output of the
        high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:14.4.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:14.4
      ref_id: 14.4.e
      description: "to intervene in the operation of the high-risk AI system or interrupt\
        \ the system through a \u2018stop\u2019 button or a similar procedure that\
        \ allows the system to come to a halt in a safe state."
    - urn: urn:intuitem:risk:req_node:ai-act:14.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      ref_id: '14.5'
      description: For high-risk AI systems referred to in point 1(a) of Annex III,
        the measures referred to in paragraph 3 of this Article shall be such as to
        ensure that, in addition, no action or decision is taken by the deployer on
        the basis of the identification resulting from the system unless that identification
        has been separately verified and confirmed by at least two natural persons
        with the necessary competence, training and authority.
    - urn: urn:intuitem:risk:req_node:ai-act:node409
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node396
      description: The requirement for a separate verification by at least two natural
        persons shall not apply to high-risk AI systems used for the purposes of law
        enforcement, migration, border control or asylum, where Union or national
        law considers the application of this requirement to be disproportionate.
    - urn: urn:intuitem:risk:req_node:ai-act:node410
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node320
      name: Article 15
      description: Accuracy, robustness and cybersecurity
    - urn: urn:intuitem:risk:req_node:ai-act:15.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      ref_id: '15.1'
      description: High-risk AI systems shall be designed and developed in such a
        way that they achieve  an appropriate level of accuracy, robustness, and cybersecurity,
        and that they perform consistently in those respects throughout their lifecycle.
    - urn: urn:intuitem:risk:req_node:ai-act:15.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      ref_id: '15.2'
      description: To address the technical aspects of how to measure the appropriate
        levels of accuracy and robustness set out in paragraph 1 and any other relevant
        performance metrics, the Commission shall, in cooperation with relevant stakeholder
        and organisations such as metrology and benchmarking authorities, encourage,
        as appropriate, the development of benchmarks and measurement methodologies.
    - urn: urn:intuitem:risk:req_node:ai-act:15.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      ref_id: '15.3'
      description: The levels of accuracy and the relevant accuracy metrics of high-risk
        AI systems shall be declared in the accompanying instructions of use.
    - urn: urn:intuitem:risk:req_node:ai-act:15.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      ref_id: '15.4'
      description: High-risk AI systems shall be as resilient as possible regarding
        errors, faults or inconsistencies that may occur within the system or the
        environment in which the system operates, in particular due to their interaction
        with natural persons or other systems. Technical and organisational measures
        shall be taken towards this regard.
    - urn: urn:intuitem:risk:req_node:ai-act:node415
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      description: The robustness of high-risk AI systems may be achieved through
        technical redundancy solutions, which may include backup or fail-safe plans.
    - urn: urn:intuitem:risk:req_node:ai-act:node416
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      description: "High-risk AI systems that continue to learn after being placed\
        \ on the market or put into service shall be developed in such a way as to\
        \ eliminate or reduce as far as possible the risk of possibly biased outputs\
        \ influencing input for future operations (\u2018feedback loops\u2019), and\
        \ as to ensure that any such feedback loops are duly addressed with appropriate\
        \ mitigation measures."
    - urn: urn:intuitem:risk:req_node:ai-act:15.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      ref_id: '15.5'
      description: High-risk AI systems shall be resilient against attempts by unauthorised
        third parties to alter their use, outputs or performance by exploiting system
        vulnerabilities.
    - urn: urn:intuitem:risk:req_node:ai-act:node418
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      description: The technical solutions aiming to ensure the cybersecurity of high-risk
        AI systems shall be appropriate to the relevant circumstances and the risks.
    - urn: urn:intuitem:risk:req_node:ai-act:node419
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node410
      description: "The technical solutions to address AI specific vulnerabilities\
        \ shall include, where appropriate, measures to prevent, detect, respond to,\
        \ resolve and control for attacks trying to manipulate the training data set\
        \ (\u2018data poisoning\u2019), or pre-trained components used in training\
        \ (\u2018model poisoning\u2019), inputs designed to cause the AI model to\
        \ make a mistake (\u2018adversarial examples\u2019 or \u2018model evasion\u2019\
        ), confidentiality attacks or model flaws."
    - urn: urn:intuitem:risk:req_node:ai-act:node420
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node300
      name: Section 3
      description: Obligations of providers and deployers of high-risk AI systems
        and other parties
    - urn: urn:intuitem:risk:req_node:ai-act:node421
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 16
      description: Obligations of providers of high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:node422
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node421
      description: 'Providers of high-risk AI systems shall:'
    - urn: urn:intuitem:risk:req_node:ai-act:16.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.a
      description: ensure that their high-risk AI systems are compliant with the requirements
        set out in Section 2;
    - urn: urn:intuitem:risk:req_node:ai-act:16.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.b
      description: indicate on the high-risk AI system or, where that is not possible,
        on its packaging or its accompanying documentation, as applicable their name,
        registered trade name or registered trade mark, the address at which they
        can be contacted;
    - urn: urn:intuitem:risk:req_node:ai-act:16.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.c
      description: have a quality management system in place which complies with Article
        17;
    - urn: urn:intuitem:risk:req_node:ai-act:16.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.d
      description: keep the documentation referred to in Article 18;
    - urn: urn:intuitem:risk:req_node:ai-act:16.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.e
      description: when under their control, keep the logs automatically generated
        by their high-risk AI systems as referred to in Article 19;
    - urn: urn:intuitem:risk:req_node:ai-act:16.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.f
      description: ensure that the high-risk AI system undergoes the relevant conformity
        assessment procedure as referred to in Article 43, prior to its being placed
        on the market or put into service;
    - urn: urn:intuitem:risk:req_node:ai-act:16.g
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.g
      description: draw up an EU declaration of conformity in accordance with Article
        47;
    - urn: urn:intuitem:risk:req_node:ai-act:16.h
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.h
      description: affix the CE marking to the high-risk AI system or, where that
        is not possible, on its packaging or its accompanying documentation, to indicate
        conformity with this Regulation, in accordance with Article 48;
    - urn: urn:intuitem:risk:req_node:ai-act:16.i
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.i
      description: comply with the registration obligations referred to in Article
        49(1);
    - urn: urn:intuitem:risk:req_node:ai-act:16.j
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.j
      description: take the necessary corrective actions and provide information as
        required in Article 20;
    - urn: urn:intuitem:risk:req_node:ai-act:16.k
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.k
      description: upon a reasoned request of a national competent authority, demonstrate
        the conformity of the high-risk AI system with the requirements set out in
        Section 2;
    - urn: urn:intuitem:risk:req_node:ai-act:16.l
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node422
      ref_id: 16.l
      description: ensure that the high-risk AI system complies with accessibility
        requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.
    - urn: urn:intuitem:risk:req_node:ai-act:node435
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 17
      description: Quality management system
    - urn: urn:intuitem:risk:req_node:ai-act:17.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node435
      ref_id: '17.1'
      description: 'Providers of high-risk AI systems shall put a quality management
        system in place that ensures compliance with this Regulation. That system
        shall be documented in a systematic and orderly manner in the form of written
        policies, procedures and instructions, and shall include at least the following
        aspects:'
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.a
      description: a strategy for regulatory compliance, including compliance with
        conformity assessment procedures and procedures for the management of modifications
        to the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.b
      description: techniques, procedures and systematic actions to be used for the
        design, design control and design verification of the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.c
      description: techniques, procedures and systematic actions to be used for the
        development, quality control and quality assurance of the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.d
      description: examination, test and validation procedures to be carried out before,
        during and after the development of the high-risk AI system, and the frequency
        with which they have to be carried out;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.e
      description: technical specifications, including standards, to be applied and,
        where the relevant harmonised standards are not applied in full or do not
        cover all of the relevant requirements set out in Section 2, the means to
        be used to ensure that the high-risk AI system complies with those requirements
        ;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.f
      description: systems and procedures for data management, including data acquisition,
        data collection, data analysis, data labelling, data storage, data filtration,
        data mining, data aggregation, data retention and any other operation regarding
        the data that is performed before and for the purpose of the placing on the
        market or the putting into service of high-risk AI systems;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.g
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.g
      description: the risk management system referred to in Article 9;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.h
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.h
      description: the setting-up, implementation and maintenance of a post-market
        monitoring system, in accordance with Article 72;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.i
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.i
      description: procedures related to the reporting of a serious incident in accordance
        with Article 73;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.j
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.j
      description: the handling of communication with national competent authorities,
        other relevant authorities, including those providing or supporting the access
        to data, notified bodies, other operators, customers or other interested parties;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.k
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.k
      description: systems and procedures for record-keeping of all relevant documentation
        and information;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.l
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.l
      description: resource management, including security-of-supply related measures;
    - urn: urn:intuitem:risk:req_node:ai-act:17.1.m
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:17.1
      ref_id: 17.1.m
      description: an accountability framework setting out the responsibilities of
        the management and other staff with regard to all the aspects listed in this
        paragraph.
    - urn: urn:intuitem:risk:req_node:ai-act:17.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node435
      ref_id: '17.2'
      description: "The implementation of the aspects referred to in paragraph 1 shall\
        \ be proportionate to the size of the provider\u2019s organisation. Providers\
        \ shall in any event comply with the degree of rigour and the level of protection\
        \ required to ensure the compliance of their high-risk AI systems with this\
        \ Regulation."
    - urn: urn:intuitem:risk:req_node:ai-act:17.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node435
      ref_id: '17.3'
      description: Providers of high-risk AI systems that are subject to obligations
        regarding quality management systems or an equivalent function under relevant
        sectorial Union law may include the aspects listed in paragraph 1 as part
        of the quality management systems pursuant to that law.
    - urn: urn:intuitem:risk:req_node:ai-act:17.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node435
      ref_id: '17.4'
      description: For providers that are financial institutions subject to requirements
        regarding their internal governance, arrangements or processes under Union
        financial services law, the obligation to put in place a quality management
        system, with the exception of paragraph 1, points (g), (h) and (i) of this
        Article, shall be deemed to be fulfilled by complying with the rules on internal
        governance arrangements or processes pursuant to the relevant Union financial
        services law. For this purpose, any harmonised standards referred to in Article
        40 shall be taken into account.
    - urn: urn:intuitem:risk:req_node:ai-act:node453
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 18
      description: Documentation keeping
    - urn: urn:intuitem:risk:req_node:ai-act:18.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node453
      ref_id: '18.1'
      description: 'The provider shall, for a period ending 10 years after the high-risk
        AI system has been placed on the market or put into service, keep at the disposal
        of the national competent authorities:'
    - urn: urn:intuitem:risk:req_node:ai-act:18.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:18.1
      ref_id: 18.1.a
      description: the technical documentation referred to in Article 11;
    - urn: urn:intuitem:risk:req_node:ai-act:18.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:18.1
      ref_id: 18.1.b
      description: the documentation concerning the quality management system referred
        to in Article 17;
    - urn: urn:intuitem:risk:req_node:ai-act:18.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:18.1
      ref_id: 18.1.c
      description: the documentation concerning the changes approved by notified bodies,
        where applicable;
    - urn: urn:intuitem:risk:req_node:ai-act:18.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:18.1
      ref_id: 18.1.d
      description: the decisions and other documents issued by the notified bodies,
        where applicable;
    - urn: urn:intuitem:risk:req_node:ai-act:18.1.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:18.1
      ref_id: 18.1.e
      description: the EU declaration of conformity referred to in Article 47.
    - urn: urn:intuitem:risk:req_node:ai-act:18.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node453
      ref_id: '18.2'
      description: Each Member State shall determine conditions under which the documentation
        referred to in paragraph 1 remains at the disposal of the national competent
        authorities for the period indicated in that paragraph for the cases when
        a provider or its authorised representative established on its territory goes
        bankrupt or ceases its activity prior to the end of that period.
    - urn: urn:intuitem:risk:req_node:ai-act:18.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node453
      ref_id: '18.3'
      description: Providers that are financial institutions subject to requirements
        regarding their internal governance, arrangements or processes under Union
        financial services law shall maintain the technical documentation as part
        of the documentation kept under the relevant Union financial services law.
    - urn: urn:intuitem:risk:req_node:ai-act:node462
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 19
      description: Automatically generated logs
    - urn: urn:intuitem:risk:req_node:ai-act:node463
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node462
      description: Providers of high-risk AI systems shall keep the logs referred
        to in Article 12(1), automatically generated by their high-risk AI systems,
        to the extent such logs are under their control. Without prejudice to applicable
        Union or national law, the logs shall be kept for a period  appropriate to
        the intended purpose of the high-risk AI system, of at least six months, unless
        provided otherwise in the applicable Union or national law, in particular
        in Union law on the protection of personal data.
    - urn: urn:intuitem:risk:req_node:ai-act:node464
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node462
      description: Providers that are financial institutions subject to requirements
        regarding their internal governance, arrangements or processes under Union
        financial services law shall maintain the logs automatically generated by
        their high-risk AI systems as part of the documentation kept under the relevant
        financial services law.
    - urn: urn:intuitem:risk:req_node:ai-act:node465
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 20
      description: Corrective actions and duty of information
    - urn: urn:intuitem:risk:req_node:ai-act:20.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node465
      ref_id: '20.1'
      description: Providers of high-risk AI systems which consider or have reason
        to consider that a high- risk AI system that they have placed on the market
        or put into service is not in conformity with this Regulation shall immediately
        take the necessary corrective actions to bring that system into conformity,
        to withdraw it, to disable it, or to recall it, as appropriate. They shall
        inform the distributors of the high-risk AI system concerned and, where applicable,
        the deployers, the authorised representative and importers accordingly.
    - urn: urn:intuitem:risk:req_node:ai-act:20.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node465
      ref_id: '20.2'
      description: Where the high-risk AI system presents a risk within the meaning
        of Article 79(1) and the provider becomes aware of that risk, it shall immediately
        investigate the causes, in collaboration with the reporting deployer, where
        applicable, and inform the market surveillance authorities of the Member State
        or Member States in which they made the high-risk AI system available on the
        market and, where applicable, the notified body that issued a certificate
        for that high-risk AI system in accordance with Article 44, in particular,
        of the nature of the non-compliance and of any relevant corrective action
        taken.
    - urn: urn:intuitem:risk:req_node:ai-act:node468
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 21
      description: Cooperation with competent authorities
    - urn: urn:intuitem:risk:req_node:ai-act:21.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node468
      ref_id: '21.1'
      description: Providers of high-risk AI systems shall, upon a reasoned request
        by a competent authority, provide that authority  all the information and
        documentation necessary to demonstrate the conformity of the high-risk AI
        system with the requirements set out in Section 2, in a language which can
        be easily understood by the authority in one of the official languages of
        the institutions of the Union as indicated by the Member State concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:21.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node468
      ref_id: '21.2'
      description: Upon a reasoned request by a national competent authority, providers
        shall also give the requesting national competent authority, as applicable,
        access to the automatically generated logs of the high-risk AI system referred
        to in Article 12(1), to the extent such logs are under their control.
    - urn: urn:intuitem:risk:req_node:ai-act:21.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node468
      ref_id: '21.3'
      description: Any information obtained by a national competent authority pursuant
        to this Article shall be treated in compliance with the confidentiality obligations
        set out in Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node472
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 22
      description: Authorised representatives of providers of high-risk AI system
    - urn: urn:intuitem:risk:req_node:ai-act:22.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node472
      ref_id: '22.1'
      description: Prior to making their high-risk AI systems available on the Union
        market,  providers established in third countries shall, by written mandate,
        appoint an authorised representative which is established in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:22.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node472
      ref_id: '22.2'
      description: The provider shall enable its authorised representative to perform
        the tasks specified in the mandate received from the provider.
    - urn: urn:intuitem:risk:req_node:ai-act:22.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node472
      ref_id: '22.3'
      description: 'The authorised representative shall perform the tasks specified
        in the mandate received from the provider. It shall provide a copy of the
        mandate to the market surveillance authorities upon request, in one of the
        official languages of the institutions of the Union, as indicated by the national
        competent authority. For the purposes of this Regulation, the mandate shall
        empower the authorised representative to carry out the following tasks:'
    - urn: urn:intuitem:risk:req_node:ai-act:22.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:22.3
      ref_id: 22.3.a
      description: verify that the EU declaration of conformity and the technical
        documentation referred to in Article 11 have been drawn up and that an appropriate
        conformity assessment procedure has been carried out by the provider;
    - urn: urn:intuitem:risk:req_node:ai-act:22.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:22.3
      ref_id: 22.3.b
      description: keep at the disposal of the national competent authorities and
        national authorities or bodies referred to in Article 74(10), for a period
        of 10 years after the high-risk AI system has been placed on the market or
        put into service, the contact details of the provider that appointed the authorised
        representative, a copy of the EU declaration of conformity, the technical
        documentation and, if applicable, the certificate issued by the notified body;
    - urn: urn:intuitem:risk:req_node:ai-act:22.3.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:22.3
      ref_id: 22.3.c
      description: provide a national competent authority, upon a reasoned request,
        with all the information and documentation, including that referred to in
        point (b) of this subparagraph, necessary to demonstrate the conformity of
        a high-risk AI system with the requirements set out in Section 2, including
        access to the logs, as referred to in Article 12(1), automatically generated
        by the high-risk AI system, to the extent such logs are under the control
        of the provider ;
    - urn: urn:intuitem:risk:req_node:ai-act:22.3.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:22.3
      ref_id: 22.3.d
      description: cooperate with competent  authorities, upon a reasoned request,
        in any action the latter take in relation to the high-risk AI system, in particular
        to reduce and mitigate the risks posed by the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:22.3.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:22.3
      ref_id: 22.3.e
      description: where applicable, comply with the registration obligations referred
        in Article 49(1), or, if the registration is carried out by the provider itself,
        ensure that the information referred to in Section A of Annex VIII is correct.
    - urn: urn:intuitem:risk:req_node:ai-act:node481
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node472
      description: The mandate shall empower the authorised representative to be addressed,
        in addition to or instead of the provider, by the competent authorities, on
        all issues related to ensuring compliance with this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:22.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node472
      ref_id: '22.4'
      description: The authorised representative shall terminate the mandate if it
        considers or has reason to consider the provider to be acting contrary to
        its obligations pursuant to this Regulation. In such a case, it shall also
        immediately inform the market surveillance authority of the Member State in
        which it is located or established, as well as, where applicable, the relevant
        notified body, about the termination of the mandate and the reasons therefor.
    - urn: urn:intuitem:risk:req_node:ai-act:node483
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: 'Article 23 '
      description: Obligations of importers
    - urn: urn:intuitem:risk:req_node:ai-act:23.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.1'
      description: 'Before placing a high-risk AI system on the market, importers
        shall ensure that the system is in conformity with this Regulation by verifying
        that:'
    - urn: urn:intuitem:risk:req_node:ai-act:23.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:23.1
      ref_id: 23.1.a
      description: the relevant conformity assessment procedure referred to in Article
        43 has been carried out by the provider of the high-risk AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:23.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:23.1
      ref_id: 23.1.b
      description: the provider has drawn up the technical documentation in accordance
        with Article 11 and Annex IV;
    - urn: urn:intuitem:risk:req_node:ai-act:23.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:23.1
      ref_id: 23.1.c
      description: the system bears the required CE marking and is accompanied by
        the EU declaration of conformity and instructions for use;
    - urn: urn:intuitem:risk:req_node:ai-act:23.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:23.1
      ref_id: 23.1.d
      description: the provider has appointed an authorised representative in accordance
        with Article 22(1)
    - urn: urn:intuitem:risk:req_node:ai-act:23.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.2'
      description: Where an importer has sufficient reason to consider that a high-risk
        AI system is not in conformity with this Regulation, or is falsified, or accompanied
        by falsified documentation, it shall not place the system on the market until
        it has been brought into conformity. Where the high-risk AI system presents
        a risk within the meaning of Article 79(1), the importer shall inform the
        provider of the system, the authorised representatives and the market surveillance
        authorities to that effect.
    - urn: urn:intuitem:risk:req_node:ai-act:23.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.3'
      description: Importers shall indicate their name, registered trade name or registered
        trade mark, and the address at which they can be contacted in relation to
        the high-risk AI system on its packaging or its accompanying documentation,
        where applicable.
    - urn: urn:intuitem:risk:req_node:ai-act:23.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.4'
      description: Importers shall ensure that, while a high-risk AI system is under
        their responsibility, storage or transport conditions, where applicable, do
        not jeopardise its compliance with the requirements set out in Section 2.
    - urn: urn:intuitem:risk:req_node:ai-act:23.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.5'
      description: Importers shall keep, for a period of 10 years after the high-risk
        AI system has been placed on the market or put into service, a copy of the
        certificate issued by the notified body, where applicable, of the instructions
        for use, and of the EU declaration of conformity.
    - urn: urn:intuitem:risk:req_node:ai-act:23.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.6'
      description: Importers shall provide national competent authorities, upon a
        reasoned request, with all the necessary information and documentation, including
        that kept in accordance with paragraph 5, to demonstrate the conformity of
        a high-risk AI system with the requirements set out in Section 2 in a language
        which can be easily understood by them. For this purpose, they shall also
        ensure that the technical documentation can be made available to those authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:23.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node483
      ref_id: '23.7'
      description: Importers shall cooperate with national competent authorities in
        any action those authorities take in relation to a high-risk AI system the
        importers placed on the market, in particular to reduce and mitigate the risks
        posed by it.
    - urn: urn:intuitem:risk:req_node:ai-act:node495
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 24
      description: Obligations of distributors
    - urn: urn:intuitem:risk:req_node:ai-act:24.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.1'
      description: Before making a high-risk AI system available on the market, distributors
        shall verify that it bears the required CE marking, that it is accompanied
        by a copy of EU declaration of conformity and instructions for use, and that
        the provider and the importer of the system, as applicable, have complied
        with their respective obligations as laid down in Article 16, points (b) and
        (c) and Article 23(3).
    - urn: urn:intuitem:risk:req_node:ai-act:24.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.2'
      description: Where a distributor considers or has reason to consider, on the
        basis of the information in its possession, a high-risk AI system not to be
        in conformity with the requirements set out in Section 2, it shall not make
        the high-risk AI system available on the market until the system has been
        brought into conformity with those requirements. Furthermore, where the high-risk
        AI system presents a risk within the meaning of Article 79(1), the distributor
        shall inform the provider or the importer of the system, as applicable, to
        that effect.
    - urn: urn:intuitem:risk:req_node:ai-act:24.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.3'
      description: Distributors shall ensure that, while a high-risk AI system is
        under their responsibility, where applicable, storage or transport conditions
        do not jeopardise the compliance of the system with the requirements set out
        in Section 2.
    - urn: urn:intuitem:risk:req_node:ai-act:24.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.4'
      description: A distributor that considers or has reason to consider, on the
        basis of the information in its possession, a high-risk AI system which it
        has made available on the market not to be in conformity with the requirements
        set out in Section 2, shall take the corrective actions necessary to bring
        that system into conformity with those requirements, to withdraw it or recall
        it, or shall ensure that the provider, the importer or any relevant operator,
        as appropriate, takes those corrective actions. Where the high-risk AI system
        presents a risk within the meaning of Article 79(1), the distributor shall
        immediately inform the provider or importer of the system and the national
        competent authorities of the Member States in which it has made the product
        available to that effect, giving details, in particular, of the non-compliance
        and of any corrective actions taken.
    - urn: urn:intuitem:risk:req_node:ai-act:24.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.5'
      description: 'Upon a reasoned request from a national competent authority, distributors
        of a high-risk AI system shall provide that authority with all the information
        and documentation regarding its actions pursuant to paragraphs 1 to 4 necessary
        to demonstrate the conformity of that system with the requirements set out
        in Section 2. '
    - urn: urn:intuitem:risk:req_node:ai-act:24.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node495
      ref_id: '24.6'
      description: Distributors shall cooperate with national competent authorities
        in any action those authorities take in relation to a high-risk AI system
        they made available on the market, in particular to reduce or mitigate the
        risk posed by it.
    - urn: urn:intuitem:risk:req_node:ai-act:node502
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 25
      description: Responsibilities along the AI value chain
    - urn: urn:intuitem:risk:req_node:ai-act:25.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      ref_id: '25.1'
      description: 'Any distributor, importer, deployer or other third-party shall
        be considered to be a provider of a high-risk AI system for the purposes of
        this Regulation and shall be subject to the obligations of the provider under
        Article 16, in any of the following circumstances:'
    - urn: urn:intuitem:risk:req_node:ai-act:25.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:25.1
      ref_id: 25.1.a
      description: they put their name or trademark on a high-risk AI system already
        placed on the market or put into service, without prejudice to contractual
        arrangements stipulating that the obligations therein are allocated otherwise;
    - urn: urn:intuitem:risk:req_node:ai-act:25.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:25.1
      ref_id: 25.1.b
      description: they make a substantial modification to a high-risk AI system that
        has already been placed on the market or has already been put into service
        in such a way that it remains a high-risk AI system pursuant to Article 6;
    - urn: urn:intuitem:risk:req_node:ai-act:25.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:25.1
      ref_id: 25.1.c
      description: they modify the intended purpose of an AI system, including a general-purpose
        AI system, which has not been classified as high-risk and has already been
        placed on the market or put into service in such a way that the AI system
        concerned becomes a high-risk AI system in accordance with Article 6.
    - urn: urn:intuitem:risk:req_node:ai-act:25.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      ref_id: '25.2'
      description: Where the circumstances referred to in paragraph 1 occur, the provider
        that initially placed the  AI system on the market or put it into service
        shall no longer be considered to be a provider of that specific AI system
        for the purposes of this Regulation. That initial provider shall closely cooperate
        with new providers and shall make available the necessary information and
        provide the reasonably expected technical access and other assistance that
        are required for the fulfilment of the obligations set out in this Regulation,
        in particular regarding the compliance with the conformity assessment of high-risk
        AI systems. This paragraph shall not apply in cases where the initial provider
        has clearly specified that its AI system is not to be changed into a high-risk
        AI system and therefore does not fall under the obligation to hand over the
        documentation
    - urn: urn:intuitem:risk:req_node:ai-act:25.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      ref_id: '25.3'
      description: 'In the case of high-risk AI systems that are safety components
        of products covered by the Union harmonisation legislation listed in Section
        A of Annex I, the product manufacturer shall be considered to be the provider
        of the high-risk AI system, and shall be subject to the obligations under
        Article 16 under either of the following circumstances:'
    - urn: urn:intuitem:risk:req_node:ai-act:25.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:25.3
      ref_id: 25.3.a
      description: the high-risk AI system is placed on the market together with the
        product under the name or trademark of the product manufacturer;
    - urn: urn:intuitem:risk:req_node:ai-act:25.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:25.3
      ref_id: 25.3.b
      description: the high-risk AI system is put into service under the name or trademark
        of the product manufacturer after the product has been placed on the mark
    - urn: urn:intuitem:risk:req_node:ai-act:25.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      ref_id: '25.4'
      description: The provider of a high-risk AI system and the third party that
        supplies an AI system, tools, services, components, or processes that are
        used or integrated in a high-risk AI system shall, by written agreement, specify
        the necessary information, capabilities, technical access and other assistance
        based on the generally acknowledged state of the art, in order to enable the
        provider of the high-risk AI system to fully comply with the obligations set
        out in this Regulation. This paragraph shall not apply to third parties making
        accessible to the public tools, services, processes, or components, other
        than general-purpose AI models, under a free and open licence.
    - urn: urn:intuitem:risk:req_node:ai-act:node512
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      description: The AI Office may develop and recommend voluntary model terms for
        contracts between providers of high-risk AI systems and third parties that
        supply tools, services, components or processes that are used for or integrated
        into high-risk AI systems. When developing those voluntary model terms, the
        AI Office shall take into account possible contractual requirements applicable
        in specific sectors or business cases. The voluntary model terms shall be
        published and be available free of charge in an easily usable electronic format.
    - urn: urn:intuitem:risk:req_node:ai-act:25.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node502
      ref_id: '25.5'
      description: Paragraphs 2 and 3 are without prejudice to the need to observe
        and protect intellectual property rights, confidential business information
        and trade secrets in accordance with Union and national law.
    - urn: urn:intuitem:risk:req_node:ai-act:node514
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 26
      description: Obligations of deployers of high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:26.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.1'
      description: Deployers of high-risk AI systems shall take appropriate technical
        and organisational measures to ensure they use such systems in accordance
        with the instructions for use accompanying the systems, pursuant to paragraphs
        3 and 6.
    - urn: urn:intuitem:risk:req_node:ai-act:26.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.2'
      description: Deployers shall assign human oversight to natural persons who have
        the necessary competence, training and authority, as well as the necessary
        support.
    - urn: urn:intuitem:risk:req_node:ai-act:26.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.3'
      description: "The obligations set out in paragraphs 1 and 2, are without prejudice\
        \ to other deployer obligations under Union or national law and to the deployer\u2019\
        s freedom to organise its own resources and activities for the purpose of\
        \ implementing the human oversight measures indicated by the provider."
    - urn: urn:intuitem:risk:req_node:ai-act:26.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.4'
      description: Without prejudice to paragraphs 1 and 2, to the extent the deployer
        exercises control over the input data, that deployer shall ensure that input
        data is relevant and sufficiently representative in view of the intended purpose
        of the high-risk AI system.
    - urn: urn:intuitem:risk:req_node:ai-act:26.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.5'
      description: Deployers shall monitor the operation of the high-risk AI system
        on the basis of the instructions for use and, where relevant, inform providers
        in accordance with Article 72. Where deployers have reason to consider that
        the use of the high-risk AI system in accordance with the instructions may
        present a risk within the meaning of Article 79(1), they shall, without undue
        delay, inform the provider or distributor and the relevant market surveillance
        authority, and shall suspend the use of that system. Where deployers have
        identified a serious incident, they shall also immediately inform first the
        provider, and then the importer or distributor and the relevant market surveillance
        authorities of that incident. If the deployer is not able to reach the provider,
        Article 73 shall apply mutatis mutandis. This obligation shall not cover sensitive
        operational data of deployers of AI systems which are law enforcement authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:node520
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: For deployers that are financial institutions subject to requirements
        regarding their internal governance, arrangements or processes under Union
        financial services law, the monitoring obligation set out in the first subparagraph
        shall be deemed to be fulfilled by complying with the rules on internal governance
        arrangements, processes and mechanisms pursuant to the relevant financial
        service law.
    - urn: urn:intuitem:risk:req_node:ai-act:26.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.6'
      description: Deployers of high-risk AI systems shall keep the logs automatically
        generated by that high-risk AI system  to the extent such logs are under their
        control, for a period appropriate to the intended purpose of the high-risk
        AI system, of at least six months, unless provided otherwise in applicable
        Union or national law, in particular in Union law on the protection of personal
        data.
    - urn: urn:intuitem:risk:req_node:ai-act:node522
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: Deployers that are financial institutions subject to requirements
        regarding their internal governance, arrangements or processes under Union
        financial services law shall maintain the logs as part of the documentation
        kept pursuant to the relevant Union financial service law.
    - urn: urn:intuitem:risk:req_node:ai-act:26.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.7'
      description: "Before putting into service or using a high-risk AI system at\
        \ the workplace, deployers who are employers shall inform workers\u2019 representatives\
        \ and the affected workers that they will be subject to the use of the high-risk\
        \ AI system. This information shall be provided, where applicable, in accordance\
        \ with the rules and procedures laid down in Union and national law and practice\
        \ on information of workers and their representatives."
    - urn: urn:intuitem:risk:req_node:ai-act:26.8
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.8'
      description: Deployers of high-risk AI systems that are public authorities,
        or Union institutions, bodies, offices or agencies shall comply with the registration
        obligations referred to in Article 49. When such deployers find that the high-risk
        AI system that they envisage using has not been registered in the EU database
        referred to in Article 71, they shall not use that system and shall inform
        the provider or the distributor
    - urn: urn:intuitem:risk:req_node:ai-act:26.9
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.9'
      description: 'Where applicable, deployers of high-risk AI systems shall use
        the information provided under Article 13 of this Regulation to comply with
        their obligation to carry out a data protection impact assessment under Article
        35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680. '
    - urn: urn:intuitem:risk:req_node:ai-act:26.10
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.10'
      description: Without prejudice to Directive (EU) 2016/680, in the framework
        of an investigation for the targeted search of a person suspected or convicted
        of having committed a criminal offence, the deployer of a high-risk AI system
        for post-remote biometric identification shall request an authorisation, ex-ante,
        or without undue delay and no later than 48 hours, by a judicial authority
        or an administrative authority whose decision is binding and subject to judicial
        review, for the use of that system, except when it is used for the initial
        identification of a potential suspect based on objective and verifiable facts
        directly linked to the offence. Each use shall be limited to what is strictly
        necessary for the investigation of a specific criminal offence.
    - urn: urn:intuitem:risk:req_node:ai-act:node527
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: If the requested authorisation provided for in the first subparagraph
        is rejected, the use of the post-remote biometric identification system linked
        to that requested authorisation shall be stopped with immediate effect and
        the personal data linked to the use of the high-risk AI system for which the
        authorisation was requested shall be deleted.
    - urn: urn:intuitem:risk:req_node:ai-act:node528
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: In no case shall such high-risk AI system for post-remote biometric
        identification be used for law enforcement purposes in an untargeted way,
        without any link to a criminal offence, a criminal proceeding, a genuine and
        present or genuine and foreseeable threat of a criminal offence, or the search
        for a specific missing person. It shall be ensured that no decision that produces
        an adverse legal effect on a person may be taken by the law enforcement authorities
        based solely on the output of such post-remote biometric identification systems.
    - urn: urn:intuitem:risk:req_node:ai-act:node529
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: This paragraph is without prejudice to Article 9 of Regulation
        (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing
        of biometric data.
    - urn: urn:intuitem:risk:req_node:ai-act:node530
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: 'Regardless of the purpose or deployer, each use of such high-risk
        AI systems shall be documented in the relevant police file and shall be made
        available to the relevant market surveillance authority and the national data
        protection authority upon request, excluding the disclosure of sensitive operational
        data related to law enforcement. This subparagraph shall be without prejudice
        to the powers conferred by

        Directive (EU) 2016/680 on supervisory authorities.'
    - urn: urn:intuitem:risk:req_node:ai-act:node531
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: Deployers shall submit annual reports to the relevant market surveillance
        and national data protection authorities on their use of post-remote biometric
        identification systems, excluding the disclosure of sensitive operational
        data related to law enforcement. The reports may be aggregated to cover more
        than one deployment.
    - urn: urn:intuitem:risk:req_node:ai-act:node532
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      description: Member States may introduce, in accordance with Union law, more
        restrictive laws on the use of post-remote biometric identification systems.
    - urn: urn:intuitem:risk:req_node:ai-act:26.11
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.11'
      description: Without prejudice to Article 50 of this Regulation, deployers of
        high-risk AI systems referred to in Annex III that make decisions or assist
        in making decisions related to natural persons shall inform the natural persons
        that they are subject to the use of the high-risk AI system. For high-risk
        AI systems used for law enforcement purposes Article 13 of Directive (EU)
        2016/680 shall apply.
    - urn: urn:intuitem:risk:req_node:ai-act:26.12
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node514
      ref_id: '26.12'
      description: Deployers shall cooperate with the relevant national competent
        authorities in any action those authorities take in relation to the high-risk
        AI system in order to implement this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node535
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node420
      name: Article 27
      description: Fundamental rights impact assessment for high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:27.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node535
      ref_id: '27.1'
      description: 'Prior to deploying a high-risk AI system referred to in Article
        6(2) into use, with the exception of high-risk AI systems intended to be used
        in the area listed in point 2 of Annex III, deployers that are bodies governed
        by public law, or are private entities providing public services, and deployers
        high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall
        perform an assessment of the impact on fundamental rights that the use of
        such system may produce. For that purpose, deployers shall perform an assessment
        consisting of:'
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.a
      description: "a description of the deployer\u2019s processes in which the high-risk\
        \ AI system will be used in line with its intended purpose;"
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.b
      description: a description of the period of time within which, and the frequency
        with which, each high-risk AI system is intended to be used;
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.c
      description: the categories of natural persons and groups likely to be affected
        by its use in the specific context;
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.d
      description: the specific risks of harm likely to have an impact on the categories
        of persons or groups of persons identified pursuant point (c) of this paragraph,
        taking into account the information given by the provider pursuant to Article
        13;
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.e
      description: a description of the implementation of human oversight measures,
        according to the instructions for use;
    - urn: urn:intuitem:risk:req_node:ai-act:27.1.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:27.1
      ref_id: 27.1.f
      description: the measures to be taken where those risks materialise, including
        the arrangements for internal governance and complaint mechanisms.
    - urn: urn:intuitem:risk:req_node:ai-act:27.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node535
      ref_id: '27.2'
      description: The obligation laid down in paragraph 1 applies to the first use
        of the high-risk AI system. The deployer may, in similar cases, rely on previously
        conducted fundamental rights impact assessments or existing impact assessments
        carried out by provider. If, during the use of the high-risk AI system, the
        deployer considers that any of the elements listed in paragraph 1 has changed
        or is no longer up to date, the deployer shall take the necessary steps to
        update the information.
    - urn: urn:intuitem:risk:req_node:ai-act:27.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node535
      ref_id: '27.3'
      description: Once the assessment referred to in paragraph 1 of this Article
        has been performed, the deployer shall notify the market surveillance authority
        of its results, including filling-out and submitting the template referred
        to in paragraph 5 of this Article as part of the notification. In the case
        referred to in Article 46(1), deployers may be exempt from that obligation
        to notify.
    - urn: urn:intuitem:risk:req_node:ai-act:27.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node535
      ref_id: '27.4'
      description: If any of the obligations laid down in this Article is already
        complied with as a result of the data protection impact assessment conducted
        pursuant to Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive
        (EU) 2016/680, the fundamental rights impact assessment referred to in paragraph
        1 of this Article shall complement that data protection impact assessment.
    - urn: urn:intuitem:risk:req_node:ai-act:27.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node535
      ref_id: '27.5'
      description: The AI Office shall develop a template for a questionnaire, including
        through an automated tool, to facilitate deployers in complying with their
        obligations under this Article in a simplified manner.
    - urn: urn:intuitem:risk:req_node:ai-act:node547
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node300
      name: Section 4
      description: Notifying authorities and notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:node548
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 28
      description: Notifying authorities
    - urn: urn:intuitem:risk:req_node:ai-act:28.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.1'
      description: Each Member State shall designate or establish at least one notifying
        authority responsible for setting up and carrying out the necessary procedures
        for the assessment, designation and notification of conformity assessment
        bodies and for their monitoring. Those procedures shall be developed in cooperation
        between the notifying authorities of all Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:28.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.2'
      description: Member States may decide that the assessment and monitoring referred
        to in paragraph 1 shall be carried out by a national accreditation body within
        the meaning of, and in accordance with, Regulation (EC) No 765/2008  .
    - urn: urn:intuitem:risk:req_node:ai-act:28.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.3'
      description: Notifying authorities shall be established, organised and operated
        in such a way that no conflict of interest arises with conformity assessment
        bodies, and that the objectivity and impartiality of their activities are
        safeguarded.
    - urn: urn:intuitem:risk:req_node:ai-act:28.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.4'
      description: Notifying authorities shall be organised in such a way that decisions
        relating to the notification of conformity assessment bodies are taken by
        competent persons different from those who carried out the assessment of those
        bodies.
    - urn: urn:intuitem:risk:req_node:ai-act:28.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.5'
      description: Notifying authorities shall offer or provide neither any activities
        that conformity assessment bodies perform, nor any consultancy services on
        a commercial or competitive basis.
    - urn: urn:intuitem:risk:req_node:ai-act:28.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.6'
      description: Notifying authorities shall safeguard the confidentiality of the
        information they obtain, in accordance with Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:28.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node548
      ref_id: '28.7'
      description: Notifying authorities shall have an adequate number of competent
        personnel at their disposal for the proper performance of their tasks. Competent
        personnel shall have the necessary expertise, where applicable, for their
        function, in fields such as information technologies, AI and law, including
        the supervision of fundamental rights.
    - urn: urn:intuitem:risk:req_node:ai-act:node556
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 29
      description: Application of a conformity assessment body for notification
    - urn: urn:intuitem:risk:req_node:ai-act:29.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node556
      ref_id: '29.1'
      description: Conformity assessment bodies shall submit an application for notification
        to the notifying authority of the Member State in which they are established.
    - urn: urn:intuitem:risk:req_node:ai-act:29.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node556
      ref_id: '29.2'
      description: The application for notification shall be accompanied by a description
        of the conformity assessment activities, the conformity assessment module
        or modules and the types of AI systems for which the conformity assessment
        body claims to be competent, as well as by an accreditation certificate, where
        one exists, issued by a national accreditation body attesting that the conformity
        assessment body fulfils the requirements laid down in Article 31.
    - urn: urn:intuitem:risk:req_node:ai-act:node559
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node556
      description: Any valid document related to existing designations of the applicant
        notified body under any other Union harmonisation legislation shall be added.
    - urn: urn:intuitem:risk:req_node:ai-act:29.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node556
      ref_id: '29.3'
      description: Where the conformity assessment body concerned cannot provide an
        accreditation certificate, it shall provide the notifying authority with all
        the documentary evidence necessary for the verification, recognition and regular
        monitoring of its compliance with the requirements laid down in Article 31.
    - urn: urn:intuitem:risk:req_node:ai-act:29.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node556
      ref_id: '29.4'
      description: For notified bodies which are designated under any other Union
        harmonisation legislation, all documents and certificates linked to those
        designations may be used to support their designation procedure under this
        Regulation, as appropriate. The notified body shall update the documentation
        referred to in paragraphs 2 and 3 of this Article whenever relevant changes
        occur, in order to enable the authority responsible for notified bodies to
        monitor and verify continuous compliance with all the requirements laid down
        in Article 31.
    - urn: urn:intuitem:risk:req_node:ai-act:node562
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 30
      description: Notification procedure
    - urn: urn:intuitem:risk:req_node:ai-act:30.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node562
      ref_id: '30.1'
      description: Notifying authorities may  notify only conformity assessment bodies
        which have satisfied the requirements laid down in Article 31.
    - urn: urn:intuitem:risk:req_node:ai-act:30.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node562
      ref_id: '30.2'
      description: Notifying authorities shall notify the Commission and the other
        Member States, using the electronic notification tool developed and managed
        by the Commission, of each conformity assessment body referred to in paragraph
        1.
    - urn: urn:intuitem:risk:req_node:ai-act:30.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node562
      ref_id: '30.3'
      description: The notification referred to in paragraph 2 of this Article shall
        include full details of the conformity assessment activities, the conformity
        assessment module or modules, the types of AI systems concerned, and the relevant
        attestation of competence. Where a notification is not based on an accreditation
        certificate as referred to in Article 29(2), the notifying authority shall
        provide the Commission and the other Member States with documentary evidence
        which attests to the competence of the conformity assessment body and to the
        arrangements in place to ensure that that body will be monitored regularly
        and will continue to satisfy the requirements laid down in Article 31.
    - urn: urn:intuitem:risk:req_node:ai-act:30.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node562
      ref_id: '30.4'
      description: The conformity assessment body concerned may perform the activities
        of a notified body only where no objections are raised by the Commission or
        the other Member States within two weeks of a notification by a notifying
        authority where it includes an accreditation certificate referred to in Article
        29(2), or within two months of a notification by the notifying authority where
        it includes documentary evidence referred to in Article 29(3)
    - urn: urn:intuitem:risk:req_node:ai-act:30.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node562
      ref_id: '30.5'
      description: Where objections are raised, the Commission shall, without delay,
        enter into consultations with the relevant Member States and the conformity
        assessment body. Having regard thereto, the Commission shall decide whether
        the authorisation is justified. The Commission shall address its decision
        to the Member State concerned and the relevant conformity assessment body.
    - urn: urn:intuitem:risk:req_node:ai-act:node568
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 31
      description: Requirements relating to notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:31.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.1'
      description: 'A notified body shall be established under the national law of
        a Member State and shall

        have legal personality.'
    - urn: urn:intuitem:risk:req_node:ai-act:31.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.2'
      description: Notified bodies shall satisfy the organisational, quality management,
        resources and process requirements that are necessary to fulfil their tasks,
        as well as suitable cybersecurity requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:31.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.3'
      description: The organisational structure, allocation of responsibilities, reporting
        lines and operation of notified bodies shall ensure confidence in their performance,
        and in the results of the conformity assessment activities that the notified
        bodies conduct.
    - urn: urn:intuitem:risk:req_node:ai-act:31.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.4'
      description: Notified bodies shall be independent of the provider of a high-risk
        AI system in relation to which they perform conformity assessment activities.
        Notified bodies shall also be independent of any other operator having an
        economic interest in high-risk AI systems assessed, as well as of any competitors
        of the provider. This shall not preclude the use of assessed high-risk AI
        systems that are necessary for the operations of the conformity assessment
        body, or the use of such high-risk AI systems for personal purposes.
    - urn: urn:intuitem:risk:req_node:ai-act:31.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.5'
      description: Neither a conformity assessment body, its top-level management
        nor the personnel responsible for carrying out its conformity assessment tasks
        shall be directly involved in the design, development, marketing or use of
        high-risk AI systems, nor shall they represent the parties engaged in those
        activities. They shall not engage in any activity that might conflict with
        their independence of judgement or integrity in relation to conformity assessment
        activities for which they are notified. This shall, in particular, apply to
        consultancy services.
    - urn: urn:intuitem:risk:req_node:ai-act:31.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.6'
      description: Notified bodies shall be organised and operated so as to safeguard
        the independence, objectivity and impartiality of their activities. Notified
        bodies shall document and implement a structure and procedures to safeguard
        impartiality and to promote and apply the principles of impartiality throughout
        their organisation, personnel and assessment activities.
    - urn: urn:intuitem:risk:req_node:ai-act:31.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.7'
      description: Notified bodies shall have documented procedures in place ensuring
        that their personnel, committees, subsidiaries, subcontractors and any associated
        body or personnel of external bodies maintain, in accordance with Article
        78, the confidentiality of the information which comes into their possession
        during the performance of conformity assessment activities, except when its
        disclosure is required by law. The staff of notified bodies shall be bound
        to observe professional secrecy with regard to all information obtained in
        carrying out their tasks under this Regulation, except in relation to the
        notifying authorities of the Member State in which their activities are carried
        out.
    - urn: urn:intuitem:risk:req_node:ai-act:31.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.8'
      description: Notified bodies shall have procedures for the performance of activities
        which take due account of the size of a provider, the sector in which it operates,
        its structure, and the degree of complexity of the AI system concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:31.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.9'
      description: Notified bodies shall take out appropriate liability insurance
        for their conformity assessment activities, unless liability is assumed by
        the Member State in which they are established in accordance with national
        law or that Member State is itself directly responsible for the conformity
        assessment.
    - urn: urn:intuitem:risk:req_node:ai-act:31.10
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.10'
      description: Notified bodies shall be capable of carrying out all their tasks
        under this Regulation with the highest degree of professional integrity and
        the requisite competence in the specific field, whether those tasks are carried
        out by notified bodies themselves or on their behalf and under their responsibility
    - urn: urn:intuitem:risk:req_node:ai-act:31.11
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.11'
      description: Notified bodies shall have sufficient internal competences to be
        able effectively to evaluate the tasks conducted by external parties on their
        behalf. The notified body shall have permanent availability of sufficient
        administrative, technical, legal and scientific personnel who possess experience
        and knowledge relating to the relevant types of AI systems, data and data
        computing, and relating to the requirements set out in Section 2.
    - urn: urn:intuitem:risk:req_node:ai-act:31.12
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node568
      ref_id: '31.12'
      description: Notified bodies shall participate in coordination activities as
        referred to in Article 38. They shall also take part directly, or be represented
        in, European standardisation organisations, or ensure that they are aware
        and up to date in respect of relevant standards.
    - urn: urn:intuitem:risk:req_node:ai-act:node581
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 32
      description: Presumption of conformity with requirements relating to notified
        bodies
    - urn: urn:intuitem:risk:req_node:ai-act:node582
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node581
      description: Where a conformity assessment body demonstrates its conformity
        with the criteria laid down in the relevant harmonised standards or parts
        thereof, the references of which have been published in the Official Journal
        of the European Union, it shall be presumed to comply with the requirements
        set out in Article 31 in so far as the applicable harmonised standards cover
        those requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:node583
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 33
      description: Subsidiaries of notified bodies and subcontracting
    - urn: urn:intuitem:risk:req_node:ai-act:33.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node583
      ref_id: '33.1'
      description: Where a notified body subcontracts specific tasks connected with
        the conformity assessment or has recourse to a subsidiary, it shall ensure
        that the subcontractor or the subsidiary meets the requirements laid down
        in Article 31, and shall inform the notifying authority accordingly.
    - urn: urn:intuitem:risk:req_node:ai-act:33.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node583
      ref_id: '33.2'
      description: Notified bodies shall take full responsibility for their tasks
        performed by subcontractors or subsidiaries.
    - urn: urn:intuitem:risk:req_node:ai-act:33.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node583
      ref_id: '33.3'
      description: Activities may be subcontracted or carried out by a subsidiary
        only with the agreement of the provider. Notified bodies shall make a list
        of their subsidiaries publicly available.
    - urn: urn:intuitem:risk:req_node:ai-act:33.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node583
      ref_id: '33.4'
      description: The relevant documents concerning the assessment of the qualifications
        of the subcontractor or the subsidiary and the work carried out by them under
        this Regulation shall be kept at the disposal of the notifying authority for
        a period of five years from the termination date of the subcontracting activity.
    - urn: urn:intuitem:risk:req_node:ai-act:node588
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 34
      description: Operational obligations of notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:34.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node588
      ref_id: '34.1'
      description: Notified bodies shall verify the conformity of high-risk AI systems
        in accordance with the conformity assessment procedures set out in Article
        43.
    - urn: urn:intuitem:risk:req_node:ai-act:34.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node588
      ref_id: '34.2'
      description: Notified bodies shall avoid unnecessary burdens for providers when
        performing their activities, and take due account of the size of the provider,
        the sector in which it operates, its structure and the degree of complexity
        of the high-risk AI system concerned, in particular in view of minimising
        administrative burdens and compliance costs for micro- and small enterprises
        within the meaning of Recommendation 2003/361/EC. The notified body shall,
        nevertheless, respect the degree of rigour and the level of protection required
        for the compliance of the high-risk AI system with the requirements of this
        Regulation. .
    - urn: urn:intuitem:risk:req_node:ai-act:34.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node588
      ref_id: '34.3'
      description: "Notified bodies shall make available and submit upon request all\
        \ relevant documentation, including the providers\u2019 documentation, to\
        \ the notifying authority referred to in Article 28 to allow that authority\
        \ to conduct its assessment, designation, notification and monitoring activities,\
        \ and to facilitate the assessment outlined in this Section."
    - urn: urn:intuitem:risk:req_node:ai-act:node592
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 35
      description: Identification numbers and lists of notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:35.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node592
      ref_id: '35.1'
      description: The Commission shall assign a single identification number to each
        notified body, even where a body is notified under more than one Union act.
    - urn: urn:intuitem:risk:req_node:ai-act:35.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node592
      ref_id: '35.2'
      description: The Commission shall make publicly available the list of the bodies
        notified under this Regulation, including their identification numbers and
        the activities for which they have been notified. The Commission shall ensure
        that the list is kept up to date.
    - urn: urn:intuitem:risk:req_node:ai-act:node595
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 36
      description: Changes to notifications
    - urn: urn:intuitem:risk:req_node:ai-act:36.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.1'
      description: The notifying authority shall notify the Commission and the other
        Member States of any relevant changes to the notification of a notified body
        via the electronic notification tool referred to in Article 30(2).
    - urn: urn:intuitem:risk:req_node:ai-act:36.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.2'
      description: The procedures laid down in Articles 29 and 30 shall apply to extensions
        of the scope of the notification.
    - urn: urn:intuitem:risk:req_node:ai-act:node598
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      description: For changes to the notification other than extensions of its scope,
        the procedures laid down in the following paragraphs shall apply.
    - urn: urn:intuitem:risk:req_node:ai-act:36.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.3'
      description: "Where a notified body decides to cease its conformity assessment\
        \ activities, it shall inform the notifying authority and the providers concerned\
        \ as soon as possible and, in the case of a planned cessation, at least one\
        \ year before ceasing its activities. The certificates of the notified body\
        \ may remain valid for a temporary period of nine months after cessation of\
        \ the notified body\u2019s activities, on condition that another notified\
        \ body has confirmed in writing that it will assume responsibilities for the\
        \ high risk AI systems covered by those certificates. The latter notified\
        \ body shall complete a full assessment of the AI systems affected by the\
        \ end of that nine-month-period before issuing new certificates for those\
        \ systems. Where the notified body has ceased its activity, the notifying\
        \ authority shall withdraw the designation."
    - urn: urn:intuitem:risk:req_node:ai-act:36.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.4'
      description: Where a notifying authority has sufficient reason to consider that
        a notified body no longer meets the requirements laid down in Article 31,
        or that it is failing to fulfil its obligations, the notifying authority shall
        without delay investigate the matter with the utmost diligence. In that context,
        it shall inform the notified body concerned about the objections raised and
        give it the possibility to make its views known. If the notifying authority
        comes to the conclusion that the notified body  no longer meets the requirements
        laid down in Article 31 or that it is failing to fulfil its obligations, it
        shall restrict, suspend or withdraw the designation as appropriate, depending
        on the seriousness of the failure to meet those requirements or fulfil those
        obligations. It shall  immediately inform the Commission and the other Member
        States accordingly.
    - urn: urn:intuitem:risk:req_node:ai-act:36.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.5'
      description: Where its designation has been suspended, restricted, or fully
        or partially withdrawn, the notified body shall inform the providers concerned
        at the latest within 10 days.
    - urn: urn:intuitem:risk:req_node:ai-act:36.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.6'
      description: In the event of the restriction, suspension or withdrawal of a
        designation, the notifying authority shall take appropriate steps to ensure
        that the files of the notified body concerned are kept, and to make them available
        to notifying authorities in other Member States and to market surveillance
        authorities at their request.
    - urn: urn:intuitem:risk:req_node:ai-act:36.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.7'
      description: 'In the event of the restriction, suspension or withdrawal of a
        designation, the notifying authority shall:'
    - urn: urn:intuitem:risk:req_node:ai-act:36.7.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.7
      ref_id: 36.7.a
      description: assess the impact on the certificates issued by the notified body;
    - urn: urn:intuitem:risk:req_node:ai-act:36.7.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.7
      ref_id: 36.7.b
      description: submit a report on its findings to the Commission and the other
        Member States within three months of having notified the changes to the designation;
    - urn: urn:intuitem:risk:req_node:ai-act:node606
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.7
      description: require the notified body to suspend or withdraw, within a reasonable
        period of time determined by the authority, any certificates which were unduly
        issued, in order to ensure the continuing conformity of AI systems on the
        market;
    - urn: urn:intuitem:risk:req_node:ai-act:36.7.c
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.7
      ref_id: 36.7.c
      description: inform the Commission and the Member States about certificates
        the suspension or withdrawal of which it has required;
    - urn: urn:intuitem:risk:req_node:ai-act:36.7.d
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.7
      ref_id: 36.7.d
      description: provide the national competent authorities of the Member State
        in which the provider has its registered place of business with all relevant
        information about the certificates of which it has required the suspension
        or withdrawal; that authority shall take the appropriate measures, where necessary,
        to avoid a potential risk to health, safety or fundamental rights.
    - urn: urn:intuitem:risk:req_node:ai-act:36.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.8'
      description: 'With the exception of certificates unduly issued, and where a
        designation has been suspended or restricted, the certificates shall remain
        valid in one of the following circumstances:'
    - urn: urn:intuitem:risk:req_node:ai-act:36.8.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.8
      ref_id: 36.8.a
      description: the notifying authority has confirmed, within one month of the
        suspension or restriction, that there is no risk to health, safety or fundamental
        rights in relation to certificates affected by the suspension or restriction,
        and the notifying authority has outlined a timeline for actions to remedy
        the suspension or restriction; or
    - urn: urn:intuitem:risk:req_node:ai-act:36.8.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.8
      ref_id: 36.8.b
      description: the notifying authority has confirmed that no certificates relevant
        to the suspension will be issued, amended or re-issued during the course of
        the suspension or restriction, and states whether the notified body has the
        capability of continuing to monitor and remain responsible for existing certificates
        issued for the period of the suspension or restriction; In the event that
        the notifying authority determines that the notified body does not have the
        capability to support existing certificates issued, the provider of the system
        covered by the certificate shall confirm in writing to the national competent
        authorities of the Member State in which it has its registered place of business,
        within three months of the suspension or restriction, that another qualified
        notified body is temporarily assuming the functions of the notified body to
        monitor and remain responsible for the certificates during the period of suspension
        or restriction.
    - urn: urn:intuitem:risk:req_node:ai-act:36.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      ref_id: '36.9'
      description: 'With the exception of certificates unduly issued, and where a
        designation has been withdrawn, the certificates shall remain valid for a
        period of nine months under the following circumstances:'
    - urn: urn:intuitem:risk:req_node:ai-act:36.9.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.9
      ref_id: 36.9.a
      description: the national competent authority of the Member State in which the
        provider of the AI system covered by the certificate has its registered place
        of business has confirmed that there is no risk to health, safety or fundamental
        rights associated with the high-risk AI systems concerned; and
    - urn: urn:intuitem:risk:req_node:ai-act:36.9.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:36.9
      ref_id: 36.9.b
      description: another notified body has confirmed in writing that it will assume
        immediate responsibilities for assessing those AI systems and completes its
        assessment within 12 months of the withdrawal of the designation.
    - urn: urn:intuitem:risk:req_node:ai-act:node615
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node595
      description: 'In the circumstances referred to in the first subparagraph, the
        national competent authority of the Member State in which the provider of
        the system covered by the certificate has its place of business may extend
        the provisional validity of the certificates for additional periods of three
        months, which shall not exceed 12 months in total.

        The national competent authority or the notified body assuming the functions
        of the notified body affected by the change of designation shall immediately
        inform the Commission, the other Member States and the other notified bodies
        thereof.'
    - urn: urn:intuitem:risk:req_node:ai-act:node616
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 37
      description: Challenge to the competence of notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:37.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node616
      ref_id: '37.1'
      description: The Commission shall, where necessary, investigate all cases where
        there are reasons to doubt the competence of a notified body or the continued
        fulfilment by a notified body of the requirements laid down in Article 31
        and of its applicable responsibilities.
    - urn: urn:intuitem:risk:req_node:ai-act:37.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node616
      ref_id: '37.2'
      description: The notifying authority shall provide the Commission, on request,
        with all relevant information relating to the notification or the maintenance
        of the competence of the notified body concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:37.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node616
      ref_id: '37.3'
      description: The Commission shall ensure that all sensitive information obtained
        in the course of its investigations pursuant to this Article is treated confidentially
        in accordance with Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:37.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node616
      ref_id: '37.4'
      description: Where the Commission ascertains that a notified body does not meet
        or no longer meets the requirements for its notification, it shall inform
        the notifying Member State accordingly and request it to take the necessary
        corrective measures, including the suspension or withdrawal of the notification
        if necessary. Where the Member State fails to take the necessary corrective
        measures, the Commission may, by means of an implementing act, suspend, restrict
        or withdraw the designation. That implementing act shall be adopted in accordance
        with the examination procedure referred to in Article 98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:node621
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 38
      description: Coordination of notified bodies
    - urn: urn:intuitem:risk:req_node:ai-act:38.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node621
      ref_id: '38.1'
      description: The Commission shall ensure that, with regard to high-risk AI systems,
        appropriate coordination and cooperation between notified bodies active in
        the conformity assessment procedures  pursuant to this Regulation are put
        in place and properly operated in the form of a sectoral group of notified
        bodies.
    - urn: urn:intuitem:risk:req_node:ai-act:38.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node621
      ref_id: '38.2'
      description: Each notifying authority shall ensure that the bodies notified
        by it participate in the work of a group referred to in paragraph 1, directly
        or through designated representatives.
    - urn: urn:intuitem:risk:req_node:ai-act:38.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node621
      ref_id: '38.3'
      description: The Commission shall provide for the exchange of knowledge and
        best practices between the notifying authorities of the Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:node625
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node547
      name: Article 39
      description: Conformity assessment bodies of third countries
    - urn: urn:intuitem:risk:req_node:ai-act:node626
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node625
      description: Conformity assessment bodies established under the law of a third
        country with which the Union has concluded an agreement may be authorised
        to carry out the activities of notified bodies under this Regulation, provided
        that they meet the requirements in Article 31 or they ensure an equivalent
        level of compliance.
    - urn: urn:intuitem:risk:req_node:ai-act:node627
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node300
      name: Section 5
      description: Standards, conformity assessment, certificates, registration
    - urn: urn:intuitem:risk:req_node:ai-act:node628
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 40
      description: Harmonised standards and standardisation deliverables
    - urn: urn:intuitem:risk:req_node:ai-act:40.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node628
      ref_id: '40.1'
      description: High-risk AI systems which are in conformity with harmonised standards
        or parts thereof the references of which have been published in the Official
        Journal of the European Union in accordance with Regulation (EU) No 1025/2012
        shall be presumed to be in conformity with the requirements set out in Section
        2 of this Chapter or, as applicable, with the obligations set out in Chapter
        IV of this Regulation, to the extent that those standards cover those requirements
        or obligations.
    - urn: urn:intuitem:risk:req_node:ai-act:40.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node628
      ref_id: '40.2'
      description: "The Commission shall issue standardisation requests covering all\
        \ requirements set out in Section 2 of this Chapter and, as applicable, obligations\
        \ set out in Chapter IV of this Regulation, in accordance with Article 10\
        \ of Regulation (EU) No 1025/2012, without undue delay. The standardisation\
        \ request shall also ask for deliverables on reporting and documentation processes\
        \ to improve AI systems\u2019 resource performance, such as reducing the high-risk\
        \ AI system\u2019s consumption of energy and other resources consumption during\
        \ its lifecycle, and on the energy-efficient development of general- purpose\
        \ AI models. When preparing a standardisation request, the Commission shall\
        \ consult the Board and relevant stakeholders, including the advisory forum.\n\
        When issuing a standardisation request to European standardisation organisations,\
        \ the Commission shall specify that standards have to be clear, consistent,\
        \ including with the standards developed in the various sectors for products\
        \ covered by the existing Union harmonisation legislation listed in Annex\
        \ I, and aiming to ensure that AI systems or AI models placed on the market\
        \ or put into service in the Union meet the relevant requirements laid down\
        \ in this Regulation.\nThe Commission shall request the European standardisation\
        \ organisations to provide evidence of their best efforts to fulfil the objectives\
        \ referred to in the first and the second subparagraph of this paragraph in\
        \ accordance with Article 24 of Regulation (EU) No 1025/2012."
    - urn: urn:intuitem:risk:req_node:ai-act:40.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node628
      ref_id: '40.3'
      description: The participants in the standardisation process shall seek to promote
        investment and innovation in AI, including through increasing legal certainty,
        as well as the competitiveness and growth of the Union market, and shall contribute
        to strengthening global cooperation on standardisation and taking into account
        existing international standards in the field of AI that are consistent with
        Union values, fundamental rights and interests, and shall enhance multi-stakeholder
        governance ensuring a balanced representation of interests and the effective
        participation of all relevant stakeholders in accordance with Articles 5,
        6, and 7 of Regulation (EU) No 1025/2012.
    - urn: urn:intuitem:risk:req_node:ai-act:node632
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 41
      description: Common specifications
    - urn: urn:intuitem:risk:req_node:ai-act:41.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.1'
      description: 'The Commission is empowered to adopt, implementing acts establishing
        common specifications for the requirements set out in Section 2 of this Chapter
        or, as applicable, for the obligations set out in Chapter IV where the following
        conditions have been fulfilled:'
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1
      ref_id: 41.1.a
      description: 'the Commission has requested, pursuant to Article 10(1) of Regulation
        (EU) No 1025/2012, one or more European standardisation organisations to draft
        a harmonised standard for the requirements set out in Section 2 of this Chapter,
        and:'
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.a.i
      assessable: false
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1.a
      ref_id: 41.1.a.i
      description: the request has not been accepted by any of the European standardisation
        organisations; or
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.a.ii
      assessable: false
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1.a
      ref_id: 41.1.a.ii
      description: 'the harmonised standards addressing that request are not delivered
        within the deadline set in accordance with Article 10(1) of Regulation (EU)

        No 1025/2012; or'
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.a.iii
      assessable: false
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1.a
      ref_id: 41.1.a.iii
      description: the relevant harmonised standards insufficiently address fundamental
        rights concerns; or
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.a.vi
      assessable: false
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1.a
      ref_id: 41.1.a.vi
      description: the harmonised standards do not comply with the request; and
    - urn: urn:intuitem:risk:req_node:ai-act:41.1.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:41.1
      ref_id: 41.1.b
      description: no reference to harmonised standards covering the requirements
        referred to in Section 2 of this Title has been published in the Official
        Journal of the European Union in accordance with Regulation (EU) No 1025/2012,
        and no such reference is expected to be published within a reasonable period.
    - urn: urn:intuitem:risk:req_node:ai-act:node640
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      description: The implementing acts referred to in the first subparagraph of
        this paragraph shall be adopted in accordance with the examination procedure
        referred to in Article 98(2), after consulting the advisory forum referred
        to in Article 67.
    - urn: urn:intuitem:risk:req_node:ai-act:41.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.2'
      description: Before preparing a draft implementing act, the Commission shall
        inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012
        that it considers the conditions laid down in paragraph 1 of this Article
        to be fulfilled.
    - urn: urn:intuitem:risk:req_node:ai-act:41.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.3'
      description: High-risk AI systems which are in conformity with the common specifications
        referred to in paragraph 1, or parts of those specifications, shall be presumed
        to be in conformity with the requirements set out in Section 2, to the extent
        those common specifications cover those requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:41.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.4'
      description: Where a harmonised standard is adopted by a European standardisation
        organisation and proposed to the Commission for the publication of its reference
        in the Official Journal of the European Union, the Commission shall assess
        the harmonised standard in accordance with Regulation (EU) No 1025/2012. When
        reference to a harmonised standard is published in the Official Journal of
        the European Union, the Commission shall repeal the implementing acts referred
        to in paragraph 1, or parts thereof which cover the same requirements set
        out in Section 2 of this Chapter.
    - urn: urn:intuitem:risk:req_node:ai-act:41.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.5'
      description: Where providers of high-risk AI systems do not comply with the
        common specifications referred to in paragraph 1, they shall duly justify
        that they have adopted technical solutions that meet the requirements referred
        to in Section 2 to a level at least equivalent thereto.
    - urn: urn:intuitem:risk:req_node:ai-act:41.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node632
      ref_id: '41.6'
      description: Where a Member State considers that a common specification does
        not entirely meet the requirements set out in Section 2, it shall inform the
        Commission thereof with a detailed explanation. The Commission shall assess
        that information and, if appropriate, amend the implementing act establishing
        the common specification concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:node646
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 42
      description: Presumption of conformity with certain requirements
    - urn: urn:intuitem:risk:req_node:ai-act:42.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node646
      ref_id: '42.1'
      description: High-risk AI systems that have been trained and tested on data
        reflecting the specific geographical, behavioural, contextual or functional
        setting within which they are intended to be used shall be presumed to be
        in compliance with the relevant requirements laid down in Article 10(4).
    - urn: urn:intuitem:risk:req_node:ai-act:42.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node646
      ref_id: '42.2'
      description: High-risk AI systems that have been certified or for which a statement
        of conformity has been issued under a cybersecurity scheme pursuant to Regulation
        (EU) 2019/881 and the references of which have been published in the Official
        Journal of the European Union shall be presumed to be in compliance with the
        cybersecurity requirements set out in Article 15 of this Regulation in so
        far as the cybersecurity certificate or statement of conformity or parts thereof
        cover those requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:node649
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 43
      description: Conformity assessment
    - urn: urn:intuitem:risk:req_node:ai-act:43.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.1'
      description: 'For high-risk AI systems listed in point 1 of Annex III, where,
        in demonstrating the compliance of a high-risk AI system with the requirements
        set out in Section 2, the provider has applied harmonised standards referred
        to in Article 40, or, where applicable, common specifications referred to
        in Article 41, the provider shall opt for one of the following conformity
        assessment procedures based on:'
    - urn: urn:intuitem:risk:req_node:ai-act:43.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:43.1
      ref_id: 43.1.a
      description: the internal control referred to in Annex VI; or
    - urn: urn:intuitem:risk:req_node:ai-act:43.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:43.1
      ref_id: 43.1.b
      description: 'he assessment of the quality management system and the assessment
        of the technical

        documentation, with the involvement of a notified body, referred to in Annex
        VII.'
    - urn: urn:intuitem:risk:req_node:ai-act:node653
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      description: 'In demonstrating the compliance of a high-risk AI system with
        the requirements set out in Section 2, the provider shall follow the conformity
        assessment procedure set out in Annex VII where:'
    - urn: urn:intuitem:risk:req_node:ai-act:a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node653
      ref_id: a
      description: 'harmonised standards referred to in Article 40  do not exist,
        and common specifications referred to in Article 41 are not available; '
    - urn: urn:intuitem:risk:req_node:ai-act:b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node653
      ref_id: b
      description: the provider has not applied, or has applied only part of, the
        harmonised standard;
    - urn: urn:intuitem:risk:req_node:ai-act:c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node653
      ref_id: c
      description: 'the common specifications referred to in point (a) exist, but
        the provider has not

        applied them;'
    - urn: urn:intuitem:risk:req_node:ai-act:d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:node653
      ref_id: d
      description: one or more of the harmonised standards referred to in point (a)
        has been published with a restriction, and only on the part of the standard
        that was restricted.
    - urn: urn:intuitem:risk:req_node:ai-act:node658
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      description: For the purposes of the conformity assessment procedure referred
        to in Annex VII, the provider may choose any of the notified bodies. However,
        where the high-risk AI system is intended to be put into service by law enforcement,
        immigration or asylum authorities or by Union institutions, bodies, offices
        or agencies, the market surveillance authority referred to in Article 74(8)
        or (9), as applicable, shall act as a notified body.
    - urn: urn:intuitem:risk:req_node:ai-act:43.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.2'
      description: 'For high-risk AI systems referred to in points 2 to 8 of Annex
        III,  providers shall follow the conformity assessment procedure based on
        internal control as referred to in Annex VI, which does not provide for the
        involvement of a notified body. '
    - urn: urn:intuitem:risk:req_node:ai-act:43.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.3'
      description: For high-risk AI systems covered by the Union harmonisation legislation
        listed in Section A of Annex I,,, the provider shall follow the relevant conformity
        assessment procedure as required under those legal acts. The requirements
        set out in Section 2 of this Chapter shall apply to those high-risk AI systems
        and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth
        paragraph of point 4.6 of Annex VII shall also apply.
    - urn: urn:intuitem:risk:req_node:ai-act:node661
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      description: For the purposes of that assessment, notified bodies which have
        been notified under those legal acts shall be entitled to control the conformity
        of the high-risk AI systems with the requirements set out in Section 2, provided
        that the compliance of those notified bodies with requirements laid down in
        Article 31(4), (10) and (11) has been assessed in the context of the notification
        procedure under those legal acts.
    - urn: urn:intuitem:risk:req_node:ai-act:node662
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      description: Where a legal act listed in section A of Annex I enables the product
        manufacturer to opt out from a third-party conformity assessment, provided
        that that manufacturer has applied all harmonised standards covering all the
        relevant requirements, that manufacturer may use that option only if it has
        also applied harmonised standards or, where applicable, common specifications
        referred to in Article 41, covering the requirements set out in Section 2
        of this Chapter.
    - urn: urn:intuitem:risk:req_node:ai-act:43.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.4'
      description: High-risk AI systems that have already been subject to a conformity
        assessment procedure shall undergo a new conformity assessment procedure in
        the event of a substantial modification, regardless of whether the modified
        system is intended to be further distributed or continues to be used by the
        current deployer.
    - urn: urn:intuitem:risk:req_node:ai-act:node664
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      description: For high-risk AI systems that continue to learn after being placed
        on the market or put into service, changes to the high-risk AI system and
        its performance that have been pre- determined by the provider at the moment
        of the initial conformity assessment and are part of the information contained
        in the technical documentation referred to in point 2(f) of Annex IV, shall
        not constitute a substantial modification.
    - urn: urn:intuitem:risk:req_node:ai-act:43.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.5'
      description: The Commission shall adopt delegated acts in accordance with Article
        97 to update Annexes VI and VII in  light of technical progress.
    - urn: urn:intuitem:risk:req_node:ai-act:43.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node649
      ref_id: '43.6'
      description: The Commission shall adopt delegated acts in accordance with Article
        97 amending paragraphs 1 and 2 of this Article in order to subject high-risk
        AI systems referred to in points 2 to 8 of Annex III to the conformity assessment
        procedure referred to in Annex VII or parts thereof. The Commission shall
        adopt such delegated acts taking into account the effectiveness of the conformity
        assessment procedure based on internal control referred to in Annex VI in
        preventing or minimising the risks to health and safety and protection of
        fundamental rights posed by such systems, as well as the availability of adequate
        capacities and resources among notified bodies.
    - urn: urn:intuitem:risk:req_node:ai-act:node667
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: 'Article 44 '
      description: 'Certificates '
    - urn: urn:intuitem:risk:req_node:ai-act:44.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node667
      ref_id: '44.1'
      description: Certificates issued by notified bodies in accordance with Annex
        VII shall be drawn-up in a language which can be easily understood by the
        relevant authorities in the Member State in which the notified body is established.
    - urn: urn:intuitem:risk:req_node:ai-act:44.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node667
      ref_id: '44.2'
      description: Certificates shall be valid for the period they indicate, which
        shall not exceed five years for AI systems covered by Annex I, and four years
        for AI systems covered by Annex III. On the application of the provider, the
        validity of a certificate may be extended for further periods, each not exceeding
        five years for AI systems covered by Annex I, and four years for AI systems
        covered by Annex III, based on a re-assessment in accordance with the applicable
        conformity assessment procedures. Any supplement to a certificate shall remain
        valid, provided that the certificate which it supplements is valid.
    - urn: urn:intuitem:risk:req_node:ai-act:44.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node667
      ref_id: '44.3'
      description: Where a notified body finds that an AI system no longer meets the
        requirements set out in Section 2, it shall, taking account of the principle
        of proportionality, suspend or withdraw the certificate issued or impose restrictions
        on it, unless compliance with those requirements is ensured by appropriate
        corrective action taken by the provider of the system within an appropriate
        deadline set by the notified body. The notified body shall give reasons for
        its decision.
    - urn: urn:intuitem:risk:req_node:ai-act:node671
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node667
      description: An appeal procedure against decisions of the notified bodies, including
        against conformity certificates issued, shall be available.
    - urn: urn:intuitem:risk:req_node:ai-act:node672
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 45
      description: 'Information obligations of notified bodies '
    - urn: urn:intuitem:risk:req_node:ai-act:45.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node672
      ref_id: '45.1'
      description: 'Notified bodies shall inform the notifying authority of the following:

        (a) any Union technical documentation assessment certificates, any supplements
        to those certificates, and any quality management system approvals issued
        in accordance with the requirements of Annex VII;

        (b) any refusal, restriction, suspension or withdrawal of a Union technical
        documentation assessment certificate or a quality management system approval
        issued in accordance with the requirements of Annex VII;

        (c) any circumstances affecting the scope of or conditions for notification;

        (d) any request for information which they have received from market surveillance
        authorities regarding conformity assessment activities;

        (e) on request, conformity assessment activities performed within the scope
        of their notification and any other activity performed, including cross-border
        activities and subcontracting.'
    - urn: urn:intuitem:risk:req_node:ai-act:45.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node672
      ref_id: '45.2'
      description: 'Each notified body shall inform the other notified bodies of: '
    - urn: urn:intuitem:risk:req_node:ai-act:45.2.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:45.2
      ref_id: 45.2.a
      description: quality management system approvals which it has refused, suspended
        or withdrawn, and, upon request, of quality system approvals which it has
        issued;
    - urn: urn:intuitem:risk:req_node:ai-act:45.2.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:45.2
      ref_id: 45.2.b
      description: Union technical documentation assessment certificates or any supplements
        thereto which it has refused, withdrawn, suspended or otherwise restricted,
        and, upon request, of the certificates and/or supplements thereto which it
        has issued.
    - urn: urn:intuitem:risk:req_node:ai-act:45.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node672
      ref_id: '45.3'
      description: Each notified body shall provide the other notified bodies carrying
        out similar conformity assessment activities covering the same types of AI
        systems with relevant information on issues relating to negative and, on request,
        positive conformity assessment results.
    - urn: urn:intuitem:risk:req_node:ai-act:45.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node672
      ref_id: '45.4'
      description: The obligations referred to in paragraphs 1, 2 and 3 of this Article
        shall be complied with in accordance with Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node679
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 46
      description: 'Derogation from conformity assessment procedure '
    - urn: urn:intuitem:risk:req_node:ai-act:46.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.1'
      description: By way of derogation from Article 43 and upon a duly justified
        request, any market surveillance authority may authorise the placing on the
        market or the putting into service of specific high-risk AI systems within
        the territory of the Member State concerned, for exceptional reasons of public
        security or the protection of life and health of persons, environmental protection
        or the protection of key industrial and infrastructural assets. That authorisation
        shall be for a limited period while the necessary conformity assessment procedures
        are being carried out, taking into account the exceptional reasons justifying
        the derogation. The completion of those procedures shall be undertaken without
        undue delay.
    - urn: urn:intuitem:risk:req_node:ai-act:46.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.2'
      description: In a duly justified situation of urgency for exceptional reasons
        of public security or in the case of specific, substantial and imminent threat
        to the life or physical safety of natural persons, law-enforcement authorities
        or civil protection authorities may put a specific high-risk AI system into
        service without the authorisation referred to in paragraph 1, provided that
        such authorisation is requested during or after the use without undue delay.
        If the authorisation referred to in paragraph 1 is refused, the use of the
        high-risk AI system shall be stopped with immediate effect and all the results
        and outputs of such use shall be immediately discarded.
    - urn: urn:intuitem:risk:req_node:ai-act:46.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.3'
      description: The authorisation referred to in paragraph 1 shall be issued only
        if the market surveillance authority concludes that the high-risk AI system
        complies with the requirements of Section 2. The market surveillance authority
        shall inform the Commission and the other Member States of any authorisation
        issued pursuant to paragraph 1. This obligation shall not cover sensitive
        operational data in relation to the activities of law-enforcement authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:46.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.4'
      description: Where, within 15 calendar days of receipt of the information referred
        to in paragraph 3, no objection has been raised by either a Member State or
        the Commission in respect of an authorisation issued by a market surveillance
        authority of a Member State in accordance with paragraph 1, that authorisation
        shall be deemed justified.
    - urn: urn:intuitem:risk:req_node:ai-act:46.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.5'
      description: Where, within 15 calendar days of receipt of the notification referred
        to in paragraph 3, objections are raised by a Member State against an authorisation
        issued by a market surveillance authority of another Member State, or where
        the Commission considers the authorisation to be contrary to Union law, or
        the conclusion of the Member States regarding the compliance of the system
        as referred to in paragraph 3 to be unfounded, the Commission shall, without
        delay, enter into consultations with the relevant Member State. The operators
        concerned shall be consulted and have the possibility to present their views.
        Having regard thereto, the Commission shall decide whether the authorisation
        is justified. The Commission shall address its decision to the Member State
        concerned and to the relevant operators.
    - urn: urn:intuitem:risk:req_node:ai-act:46.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.6'
      description: Where the Commission considers the authorisation unjustified, it
        shall be withdrawn by the market surveillance authority of the Member State
        concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:46.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node679
      ref_id: '46.7'
      description: For high-risk AI systems related to products covered by Union harmonisation
        legislation listed in Section A of Annex I, only the derogations from the
        conformity assessment established in that Union harmonisation legislation
        shall apply.
    - urn: urn:intuitem:risk:req_node:ai-act:node687
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: Article 47
      description: 'EU declaration of conformity '
    - urn: urn:intuitem:risk:req_node:ai-act:47.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node687
      ref_id: '47.1'
      description: The provider shall draw up a written machine readable, physical
        or electronically signed EU declaration of conformity for each high-risk AI
        system, and keep it at the disposal of the national competent authorities
        for 10 years after the high-risk AI system has been placed on the market or
        put into service. The EU declaration of conformity shall identify the high-risk
        AI system for which it has been drawn up. A copy of the EU declaration of
        conformity shall be submitted to the relevant national competent authorities
        upon request.
    - urn: urn:intuitem:risk:req_node:ai-act:47.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node687
      ref_id: '47.2'
      description: The EU declaration of conformity shall state that the high-risk
        AI system concerned meets the requirements set out in Section 2. The EU declaration
        of conformity shall contain the information set out in Annex V, and shall
        be translated into a language that can be easily understood by the national
        competent authorities of the Member States in which the high-risk AI system
        is placed on the market or made available.
    - urn: urn:intuitem:risk:req_node:ai-act:47.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node687
      ref_id: '47.3'
      description: Where high-risk AI systems are subject to other Union harmonisation
        legislation which also requires an EU declaration of conformity, a single
        EU declaration of conformity shall be drawn up in respect of all Union law
        applicable to the high-risk AI system. The declaration shall contain all the
        information required to identify the Union harmonisation legislation to which
        the declaration relates.
    - urn: urn:intuitem:risk:req_node:ai-act:47.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node687
      ref_id: '47.4'
      description: By drawing up the EU declaration of conformity, the provider shall
        assume responsibility for compliance with the requirements set out in Section
        2. The provider shall keep the EU declaration of conformity up-to-date as
        appropriate.
    - urn: urn:intuitem:risk:req_node:ai-act:47.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node687
      ref_id: '47.5'
      description: The Commission shall adopt delegated acts in accordance with Article
        97 for the purpose of updating the content of the EU declaration of conformity
        set out in Annex V, in order to introduce elements that become necessary in
        light of technical progress.
    - urn: urn:intuitem:risk:req_node:ai-act:node693
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: 'Article 48 '
      description: 'CE marking '
    - urn: urn:intuitem:risk:req_node:ai-act:48.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node693
      ref_id: '48.1'
      description: 'The CE marking shall be subject to the general principles set
        out in Article 30 of Regulation (EC) No 765/2008. '
    - urn: urn:intuitem:risk:req_node:ai-act:48.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node693
      ref_id: '48.2'
      description: For high-risk AI systems provided digitally, a digital CE marking
        shall be used, only if it can easily be accessed via the interface from which
        that system is accessed or via an easily accessible machine-readable code
        or other electronic means.
    - urn: urn:intuitem:risk:req_node:ai-act:48.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node693
      ref_id: '48.3'
      description: The CE marking shall be affixed visibly, legibly and indelibly
        for high-risk AI systems. Where that is not possible or not warranted on account
        of the nature of the high-risk AI system, it shall be affixed to the packaging
        or to the accompanying documentation, as appropriate.
    - urn: urn:intuitem:risk:req_node:ai-act:48.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node693
      ref_id: '48.4'
      description: "Where applicable, the CE marking shall be followed by the identification\
        \ number of the notified body responsible for the conformity assessment procedures\
        \ set out in Article 43. The identification number of the notified body shall\
        \ be affixed by the body itself or, under its instructions, by the provider\
        \ or by the provider\u2019s authorised representative. The identification\
        \ number shall also be indicated in any promotional material which mentions\
        \ that the high-risk AI system fulfils the requirements for CE marking."
    - urn: urn:intuitem:risk:req_node:ai-act:48.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node693
      ref_id: '48.5'
      description: Where high-risk AI systems are subject to other Union law which
        also provides for the affixing of the CE marking, the CE marking shall indicate
        that the high-risk AI system also fulfil the requirements of that other law.
    - urn: urn:intuitem:risk:req_node:ai-act:node699
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node627
      name: 'Article 49 '
      description: 'Registration '
    - urn: urn:intuitem:risk:req_node:ai-act:49.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node699
      ref_id: '49.1'
      description: 'Before placing on the market or putting into service a high-risk
        AI system listed in

        Annex III, with the exception of high-risk AI systems referred to in point
        2 of Annex III, the provider or, where applicable, the authorised representative
        shall register themselves and their system in the EU database referred to
        in Article 71.'
    - urn: urn:intuitem:risk:req_node:ai-act:49.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node699
      ref_id: '49.2'
      description: Before placing on the market or putting into service an AI system
        for which the provider has concluded that it is not high-risk according to
        Article 6(3), that provider or, where applicable, the authorised representative
        shall register themselves and that system in the EU database referred to in
        Article 71.
    - urn: urn:intuitem:risk:req_node:ai-act:49.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node699
      ref_id: '49.3'
      description: Before putting into service or using a high-risk AI system listed
        in Annex III, with the exception of high-risk AI systems listed in point 2
        of Annex III, deployers who are public authorities, agencies or bodies or
        persons acting on their behalf shall register themselves, select the system
        and register its use in the EU database referred to in Article 71.
    - urn: urn:intuitem:risk:req_node:ai-act:49.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node699
      ref_id: '49.4'
      description: 'For high-risk AI systems referred to in points 1, 6 and 7 of Annex
        III, in the areas of law enforcement, migration, asylum and border control
        management, the registration referred to in paragraphs 1, 2 and 3 of this
        Article shall be in a secure non-public section of the EU database referred
        to in Article 71 and shall include only the following information, as applicable,
        referred to in:

        (a) section A, points 1 to 10, of Annex VIII, with the exception of points
        5a, 7 and 8;

        (b) section C, points 1 to 3, of Annex VIII,;

        (c) Section B, points 1 to 5, and points 8 and 9 of Annex VIII;

        (d) points 1 to 3, and point 5, of Annex IX.

        Only the Commission and national authorities referred to in Article 74(8)
        shall have access to the restricted sections of the EU database listed in
        the first subparagraph of this paragraph.'
    - urn: urn:intuitem:risk:req_node:ai-act:49.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node699
      ref_id: '49.5'
      description: High-risk AI systems referred to in point 2 of Annex III shall
        be registered at national level.
    - urn: urn:intuitem:risk:req_node:ai-act:node705
      assessable: false
      depth: 1
      name: CHAPTER IV
      description: 'TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN
        AI SYSTEMS '
    - urn: urn:intuitem:risk:req_node:ai-act:node706
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node705
      name: 'Article 50 '
      description: 'Transparency obligations for providers and users of certain AI
        systems '
    - urn: urn:intuitem:risk:req_node:ai-act:50.1
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.1'
      description: Providers shall ensure that AI systems intended to interact directly
        with natural persons are designed and developed in such a way that the natural
        persons concerned are informed that they are interacting with an AI system,
        unless this is obvious from the point of view of a natural person who is reasonably
        well-informed, observant and circumspect, taking into account the circumstances
        and the context of use. This obligation shall not apply to AI systems authorised
        by law to detect, prevent, investigate or prosecute criminal offences, subject
        to appropriate safeguards for the rights and freedoms of third parties, unless
        those systems are available for the public to report a criminal offence.
    - urn: urn:intuitem:risk:req_node:ai-act:50.2
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.2'
      description: Providers of AI systems, including general-purpose AI systems,
        generating synthetic audio, image, video or text content, shall ensure that
        the outputs of the AI system are marked in a machine-readable format and detectable
        as artificially generated or manipulated. Providers shall ensure their technical
        solutions are effective, interoperable, robust and reliable as far as this
        is technically feasible, taking into account the specificities and limitations
        of various types of content, the costs of implementation and the generally
        acknowledged state-of-the-art, as may be reflected in relevant technical standards.
        This obligation shall not apply to the extent the AI systems perform an assistive
        function for standard editing or do not substantially alter the input data
        provided by the deployer or the semantics thereof, or where authorised by
        law to detect, prevent, investigate or prosecute criminal offences.
    - urn: urn:intuitem:risk:req_node:ai-act:50.3
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.3'
      description: Deployers of an emotion recognition system or a biometric categorisation
        system shall inform the natural persons exposed thereto of the operation of
        the system, and shall process the personal data in accordance with Regulations
        (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable.
        This obligation shall not apply to AI systems used for biometric categorisation
        and emotion recognition, which are permitted by law to detect, prevent or
        investigate criminal offences, subject to appropriate safeguards for the rights
        and freedoms of third parties, and in compliance with Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:50.4
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.4'
      description: Deployers of an AI system that generates or manipulates image,
        audio or video content constituting a deep fake, shall disclose that the content
        has been artificially generated or manipulated. This obligation shall not
        apply where the use is authorised by law to detect, prevent, investigate or
        prosecute criminal offence. Where the content forms part of an evidently artistic,
        creative, satirical, fictional analogous work or programme, the transparency
        obligations set out in this paragraph are limited to disclosure of the existence
        of such generated or manipulated content in an appropriate manner that does
        not hamper the display or enjoyment of the work.
    - urn: urn:intuitem:risk:req_node:ai-act:node711
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      description: Deployers of an AI system that generates or manipulates text which
        is published with the purpose of informing the public on matters of public
        interest shall disclose that the text has been artificially generated or manipulated.
        This obligation shall not apply where the use is authorised by law to detect,
        prevent, investigate or prosecute criminal offences or where the AI-generated
        content has undergone a process of human review or editorial control and where
        a natural or legal person holds editorial responsibility for the publication
        of the content.
    - urn: urn:intuitem:risk:req_node:ai-act:50.5
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.5'
      description: The information referred to in paragraphs 1 to 4 shall be provided
        to the natural persons concerned in a clear and distinguishable manner at
        the latest at the time of the first interaction or exposure. The information
        shall conform to the applicable accessibility requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:50.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.6'
      description: 'Paragraphs 1 to 4 shall not affect the requirements and obligations
        set out in Chapter III,

        and shall be without prejudice to other transparency obligations laid down
        in Union or national law for deployers of AI systems.'
    - urn: urn:intuitem:risk:req_node:ai-act:50.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node706
      ref_id: '50.7'
      description: The AI Office shall encourage and facilitate the drawing up of
        codes of practice at Union level to facilitate the effective implementation
        of the obligations regarding the detection and labelling of artificially generated
        or manipulated content. The Commission is empowered to adopt implementing
        acts to approve those codes of practice in accordance with the procedure laid
        down in Article 56 (6), (7) and (8). If it deems the code is not adequate,
        the Commission is empowered to adopt an implementing act specifying common
        rules for the implementation of those obligations in accordance with the examination
        procedure laid down in Article 98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:node715
      assessable: false
      depth: 1
      name: CHAPTER V
      description: GENERAL-PURPOSE AI MODELS
    - urn: urn:intuitem:risk:req_node:ai-act:node716
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node715
      name: Section 1
      description: Classification rules
    - urn: urn:intuitem:risk:req_node:ai-act:node717
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node716
      name: Article 51
      description: Classification of general-purpose AI models as general-purpose
        AI models with systemic risk
    - urn: urn:intuitem:risk:req_node:ai-act:51.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node717
      ref_id: '51.1'
      description: 'A general-purpose AI model shall be classified as a general-purpose
        AI model with systemic risk if it meets any of the following requirements:'
    - urn: urn:intuitem:risk:req_node:ai-act:node719
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:51.1
      description: it has high impact capabilities evaluated on the basis of appropriate
        technical tools and methodologies, including indicators and benchmarks;
    - urn: urn:intuitem:risk:req_node:ai-act:node720
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:51.1
      description: based on a decision of the Commission, ex officio or following
        a qualified alert from the scientific panel, it has capabilities or an impact
        equivalent to those set out in point (a) having regard to the criteria set
        out in Annex XIII.
    - urn: urn:intuitem:risk:req_node:ai-act:51.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node717
      ref_id: '51.2'
      description: A general-purpose AI model shall be presumed to have high impact
        capabilities pursuant to paragraph 1, point (a), when the cumulative amount
        of computation used for its training measured in FLOPs is greater than 10^25.
    - urn: urn:intuitem:risk:req_node:ai-act:51.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node717
      ref_id: '51.3'
      description: The Commission shall adopt delegated acts in accordance with Article
        97 to amend the thresholds listed in paragraphs 2 and 3 of this Article, as
        well as to supplement benchmarks and indicators in light of evolving technological
        developments, such as algorithmic improvements or increased hardware efficiency,
        when necessary, for these thresholds to reflect the state of the art.
    - urn: urn:intuitem:risk:req_node:ai-act:node723
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node716
      name: Article 52
      description: Procedure
    - urn: urn:intuitem:risk:req_node:ai-act:52.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.1'
      description: Where a general-purpose AI model meets the requirement referred
        to in Article 51(1), point (a), the relevant provider shall notify the Commission
        without delay and in any event within two weeks after that requirement is
        met or it becomes known that it will be met. That notification shall include
        the information necessary to demonstrate that the relevant requirement has
        been met. If the Commission becomes aware of a general- purpose AI model presenting
        systemic risks of which it has not been notified, it may decide to designate
        it as a model with systemic risk.
    - urn: urn:intuitem:risk:req_node:ai-act:52.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.2'
      description: The provider of a general purpose AI model that meets the requirement
        referred to in Article 51(1), point (a), may present, with its notification,
        sufficiently substantiated arguments to demonstrate that, exceptionally, although
        it meets that requirement, the general purpose AI model does not present,
        due to its specific characteristics, systemic risks and therefore should not
        be classified as a general-purpose AI model with systemic risk.
    - urn: urn:intuitem:risk:req_node:ai-act:52.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.3'
      description: Where the Commission concludes that the arguments submitted pursuant
        to paragraph 2 are not sufficiently substantiated and the relevant provider
        was not able to demonstrate that the general-purpose AI model does not present,
        due to its specific characteristics, systemic risks, it shall reject those
        arguments, and the general-purpose AI model shall be considered to be a general-purpose
        AI model with systemic risk.
    - urn: urn:intuitem:risk:req_node:ai-act:52.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.4'
      description: 'The Commission may designate a general-purpose AI model as presenting
        systemic risks, ex officio or following a qualified alert from the scientific
        panel pursuant to Article 90(1), point (a), on the basis of criteria set out
        in Annex XIII.

        The Commission shall adopt delegated acts in accordance with Article 97 to
        specify and update the criteria set out in Annex XIII.'
    - urn: urn:intuitem:risk:req_node:ai-act:52.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.5'
      description: Upon a reasoned request of a provider whose model has been designated
        as a general- purpose AI model with systemic risk pursuant to paragraph 4,
        the Commission shall take the request into account and may decide to reassess
        whether the general-purpose AI model can still be considered to present systemic
        risks on the basis of the criteria set out in Annex XIII. Such request shall
        contain objective, detailed and new reasons that have arisen since the designation
        decision. Providers may request reassessment at the earliest six months after
        the designation decision. Where the Commission, following its reassessment,
        decides to maintain the designation as a general-purpose AI model with systemic
        risk, providers may request reassessment at the earliest six months after
        that decision.
    - urn: urn:intuitem:risk:req_node:ai-act:52.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node723
      ref_id: '52.6'
      description: The Commission shall ensure that a list of general-purpose AI models
        with systemic risk is published and shall keep that list up to date, without
        prejudice to the need to observe and protect intellectual property rights
        and confidential business information or trade secrets in accordance with
        Union and national law.
    - urn: urn:intuitem:risk:req_node:ai-act:node730
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node715
      name: Section 2
      description: Obligations for providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:node731
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node730
      name: Article 53
      description: Obligations for providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:53.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.1'
      description: 'Providers of general-purpose AI models shall:'
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1
      ref_id: 53.1.a
      description: draw up and keep up-to-date the technical documentation of the
        model, including its training and testing process and the results of its evaluation,
        which shall contain, at a minimum, the elements set out in Annex XI for the
        purpose of providing it, upon request, to the AI Office and the national competent
        authorities;
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1
      ref_id: 53.1.b
      description: 'draw up, keep up-to-date and make available information and documentation
        to providers of AI systems who intend to integrate the general-purpose AI
        model into their AI systems. Without prejudice to the need to respect and
        protect intellectual property rights and confidential business information
        or trade secrets in accordance with Union and national law, the information
        and documentation shall:'
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.b.i
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1.b
      ref_id: 53.1.b.i
      description: enable providers of AI systems to have a good understanding of
        the capabilities and limitations of the general-purpose AI model and to comply
        with their obligations pursuant to this Regulation; and
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.b.ii
      assessable: true
      depth: 6
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1.b
      ref_id: 53.1.b.ii
      description: contain, at a minimum, the elements set out in Annex XII;
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1
      ref_id: 53.1.c
      description: put in place a policy to comply with Union copyright law, and in
        particular to identify and comply with, including through state of the art
        technologies, a reservation of rights expressed pursuant to Article 4(3) of
        Directive (EU) 2019/790;
    - urn: urn:intuitem:risk:req_node:ai-act:53.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:53.1
      ref_id: 53.1.d
      description: draw up and make publicly available a sufficiently detailed summary
        about the content used for training of the general-purpose AI model, according
        to a template provided by the AI Office.
    - urn: urn:intuitem:risk:req_node:ai-act:53.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.2'
      description: The obligations set out in paragraph 1, points (a) and (b), shall
        not apply to providers of AI models that are released under a free and open
        licence that allows for the access, usage, modification, and distribution
        of the model, and whose parameters, including the weights, the information
        on the model architecture, and the information on model usage, are made publicly
        available. This exception shall not apply to general-purpose AI models with
        systemic risks.
    - urn: urn:intuitem:risk:req_node:ai-act:53.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.3'
      description: Providers of general-purpose AI models shall cooperate as necessary
        with the Commission and the national competent authorities in the exercise
        of their competences and powers pursuant to this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:53.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.4'
      description: Providers of general-purpose AI models may rely on codes of practice
        within the meaning of Article 56 to demonstrate compliance with the obligations
        set out in paragraph 1 of this Article, until a harmonised standard is published.
        Providers who are in compliance with a European harmonised standard shall
        be presumed to be in compliance with the obligations set out in paragraph
        1 of this Article. Providers of general-purpose AI models who do not adhere
        to an approved code of practice shall demonstrate alternative adequate means
        of compliance for approval by the Commission.
    - urn: urn:intuitem:risk:req_node:ai-act:53.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.5'
      description: For the purpose of facilitating compliance with Annex XI, in particular
        points 2 (d) and (e) thereof, the Commission shall adopt delegated acts in
        accordance with Article 97 to detail measurement and calculation methodologies
        with a view to allowing for comparable and verifiable documentation.
    - urn: urn:intuitem:risk:req_node:ai-act:53.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.6'
      description: The Commission shall adopt delegated acts in accordance with Article
        97(2) to amend Annexes XI and XII in the light of evolving technological developments.
    - urn: urn:intuitem:risk:req_node:ai-act:53.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node731
      ref_id: '53.7'
      description: Any information or documentation obtained pursuant to this Article,
        including trade secrets, shall be treated in compliance with the confidentiality
        obligations set out in Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node745
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node730
      name: Article 54
      description: Authorised representatives of providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:54.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.1'
      description: Prior to placing a general-purpose AI model on the Union market,
        providers established in third countries shall, by written mandate, appoint
        an authorised representative which is established in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:54.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.2'
      description: The provider shall enable its authorised representative to perform
        the tasks specified in the mandate received from the provider.
    - urn: urn:intuitem:risk:req_node:ai-act:54.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.3'
      description: 'The authorised representative shall perform the tasks specified
        in the mandate received from the provider. It shall provide a copy of the
        mandate to the AI Office upon request, in one of the official languages of
        the institutions of the Union. For the purposes of this Regulation, the mandate
        shall empower the authorised representative to carry out the following tasks:'
    - urn: urn:intuitem:risk:req_node:ai-act:54.3.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:54.3
      ref_id: 54.3.a
      description: verify that the technical documentation specified in Annex XI has
        been drawn up and all obligations referred to in Articles 53 and, where applicable,
        Article 55 have been fulfilled by the provider;
    - urn: urn:intuitem:risk:req_node:ai-act:54.3.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:54.3
      ref_id: 54.3.b
      description: keep a copy of the technical documentation specified in Annex XI
        at the disposal of the AI Office and national competent authorities, for a
        period of 10 years after the general-purpose AI model has been placed on the
        market, and keep current the contact details of the provider that appointed
        the authorised representative;
    - urn: urn:intuitem:risk:req_node:ai-act:54.3.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:54.3
      ref_id: 54.3.c
      description: provide the AI Office, upon a reasoned request, with all the information
        and documentation, including that referred to in point (b), necessary to demonstrate
        its compliance with the obligations in this Chapter;
    - urn: urn:intuitem:risk:req_node:ai-act:54.3.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:54.3
      ref_id: 54.3.d
      description: cooperate with the AI Office and national competent authorities,
        upon a reasoned request, in any action the latter take in relation to a general-purpose
        AI model with systemic risks, including when the model is integrated into
        AI systems placed on the market or put into service in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:54.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.4'
      description: The mandate shall empower the authorised representative to be addressed,
        in addition to or instead of the provider, by the AI Office or the national
        competent authorities, on all issues related to ensuring compliance with this
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:54.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.5'
      description: The authorised representative shall terminate the mandate if it
        considers or has reason to consider the provider to be acting contrary to
        its obligations pursuant to this Regulation. In such a case, it shall also
        immediately inform the AI Office about the termination of the mandate and
        the reasons therefor.
    - urn: urn:intuitem:risk:req_node:ai-act:54.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node745
      ref_id: '54.6'
      description: The obligation set out in this Article shall not apply to providers
        of general-purpose AI models that are released under a free and open source
        licence that allows for the access, usage, modification, and distribution
        of the model, and whose parameters, including the weights, the information
        on the model architecture, and the information on model usage, are made publicly
        available, unless the general-purpose AI models present systemic risks.
    - urn: urn:intuitem:risk:req_node:ai-act:node756
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node715
      name: Section 3
      description: Obligations for providers of general-purpose AI models with systemic
        risk
    - urn: urn:intuitem:risk:req_node:ai-act:node757
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node756
      name: Article 55
      description: Obligations for providers of general-purpose AI models with systemic
        risk
    - urn: urn:intuitem:risk:req_node:ai-act:55.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node757
      ref_id: '55.1'
      description: 'In addition to the obligations listed in Article 53, providers
        of general-purpose AI models with systemic risk shall:'
    - urn: urn:intuitem:risk:req_node:ai-act:55.1.a
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:55.1
      ref_id: 55.1.a
      description: perform model evaluation in accordance with standardised protocols
        and tools reflecting the state-of-the-art, including conducting and documenting
        adversarial testing of the model with a view to identifying and mitigating
        systemic risk;
    - urn: urn:intuitem:risk:req_node:ai-act:55.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:55.1
      ref_id: 55.1.b
      description: assess and mitigate possible systemic risks at Union level, including
        their sources, that may stem from the development, the placing on the market,
        or the use of general-purpose AI models with systemic risk;
    - urn: urn:intuitem:risk:req_node:ai-act:55.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:55.1
      ref_id: 55.1.c
      description: keep track of, document and report without undue delay to the AI
        Office and, as appropriate, to national competent authorities, relevant information
        about serious incidents and possible corrective measures to address them;
    - urn: urn:intuitem:risk:req_node:ai-act:55.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:55.1
      ref_id: 55.1.d
      description: ensure an adequate level of cybersecurity protection for the general-purpose
        AI model with systemic risk and the physical infrastructure of the model.
    - urn: urn:intuitem:risk:req_node:ai-act:55.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node757
      ref_id: '55.2'
      description: Providers of general-purpose AI models with systemic risk may rely
        on codes of practice within the meaning of Article 56 to demonstrate compliance
        with the obligations set out in paragraph 1 of this Article, until a harmonised
        standard is published. Providers who are in compliance with a European harmonised
        standard shall be presumed to be in compliance with the obligations set out
        in paragraph 1 of this Article. Providers of general-purpose AI models with
        systemic risks who do not adhere to an approved code of practice shall demonstrate
        alternative adequate means of compliance for approval by the Commission.
    - urn: urn:intuitem:risk:req_node:ai-act:55.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node757
      ref_id: '55.3'
      description: Any information or documentation obtained pursuant to this Article,
        including trade secrets, shall be treated in compliance with the confidentiality
        obligations set out in Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node765
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node756
      name: 'Article 56 '
      description: Codes of practice
    - urn: urn:intuitem:risk:req_node:ai-act:56.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.1'
      description: The AI Office shall encourage and facilitate the drawing up of
        codes of practice at Union level in order to contribute to the proper application
        of this Regulation, taking into account international approaches.
    - urn: urn:intuitem:risk:req_node:ai-act:56.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.2'
      description: 'The AI Office and the Board shall aim to ensure that the codes
        of practice cover at least the obligations provided for in Articles 53 and
        55, including the following issues:'
    - urn: urn:intuitem:risk:req_node:ai-act:56.2.a
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:56.2
      ref_id: 56.2.a
      description: means to ensure that the information referred to in Article 53(1),
        points (a) and (b), is kept up to date in the light of market and technological
        developments;
    - urn: urn:intuitem:risk:req_node:ai-act:56.2.b
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:56.2
      ref_id: 56.2.b
      description: the adequate level of detail for the summary about the content
        used for training;
    - urn: urn:intuitem:risk:req_node:ai-act:56.2.c
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:56.2
      ref_id: 56.2.c
      description: the identification of the type and nature of the systemic risks
        at Union level, including their sources, where appropriate;
    - urn: urn:intuitem:risk:req_node:ai-act:56.2.d
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:56.2
      ref_id: 56.2.d
      description: the measures, procedures and modalities for the assessment and
        management of the systemic risks at Union level, including the documentation
        thereof, which shall be proportionate to the risks, take into consideration
        their severity and probability and take into account the specific challenges
        of tackling those risks in the light of the possible ways in which such risks
        may emerge and materialise along the AI value chain.
    - urn: urn:intuitem:risk:req_node:ai-act:56.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.3'
      description: The AI Office may invite all providers of general-purpose AI models,
        as well as relevant national competent authorities, to participate in the
        drawing-up of codes of practice. Civil society organisations, industry, academia
        and other relevant stakeholders, such as downstream providers and independent
        experts, may support the process.
    - urn: urn:intuitem:risk:req_node:ai-act:56.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.4'
      description: The AI Office and the Board shall aim to ensure that the codes
        of practice clearly set out their specific objectives and contain commitments
        or measures, including key performance indicators as appropriate, to ensure
        the achievement of those objectives, and that they take due account of the
        needs and interests of all interested parties, including affected persons,
        at Union level.
    - urn: urn:intuitem:risk:req_node:ai-act:56.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.5'
      description: The AI Office shall aim to ensure that participants to the codes
        of practice report regularly to the AI Office on the implementation of the
        commitments and the measures taken and their outcomes, including as measured
        against the key performance indicators as appropriate. Key performance indicators
        and reporting commitments shall reflect differences in size and capacity between
        various participants.
    - urn: urn:intuitem:risk:req_node:ai-act:56.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.6'
      description: The AI Office and the Board shall regularly monitor and evaluate
        the achievement of the objectives of the codes of practice by the participants
        and their contribution to the proper application of this Regulation. The AI
        Office and the Board shall assess whether the codes of practice cover the
        obligations provided for in Articles 53 and 55, as well as the issues listed
        in paragraph 2 of this Article, and shall regularly monitor and evaluate the
        achievement of their objectives. They shall publish their assessment of the
        adequacy of the codes of practice.
    - urn: urn:intuitem:risk:req_node:ai-act:node776
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      description: The Commission may, by way of an implementing act, approve a code
        of practice and give it a general validity within the Union. That implementing
        act shall be adopted in accordance with the examination procedure referred
        to in Article 98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:56.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.7'
      description: The AI Office may invite all providers of general-purpose AI models
        to adhere to the codes of practice. For providers of general-purpose AI models
        not presenting systemic risks this adherence may be limited to the obligations
        provided for in Article 53, unless they declare explicitly their interest
        to join the full code.
    - urn: urn:intuitem:risk:req_node:ai-act:56.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.8'
      description: The AI Office shall, as appropriate, also encourage and facilitate
        the review and adaptation of the codes of practice, in particular in the light
        of emerging standards. The AI Office shall assist in the assessment of available
        standards.
    - urn: urn:intuitem:risk:req_node:ai-act:56.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node765
      ref_id: '56.9'
      description: Codes of practice shall be ready at the latest by 2 May 2025. The
        AI Office shall take the necessary steps, including inviting providers pursuant
        to paragraph 7.
    - urn: urn:intuitem:risk:req_node:ai-act:node780
      assessable: false
      depth: 1
      name: CHAPTER VI
      description: MEASURES IN SUPPORT OF INNOVATION
    - urn: urn:intuitem:risk:req_node:ai-act:node781
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 57
      description: AI regulatory sandboxes
    - urn: urn:intuitem:risk:req_node:ai-act:57.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.1'
      description: 'Member States shall ensure that their competent authorities establish
        at least one AI regulatory sandbox at national level, which shall be operational
        by 2 August 2026. That sandbox may also be established jointly with the competent
        authorities of other Member States. The Commission may provide technical support,
        advice and tools for the establishment and operation of AI regulatory sandboxes.

        The obligation under the first subparagraph may also be fulfilled by participating
        in an existing sandbox in so far as that participation provides an equivalent
        level of national coverage for the participating Member States.'
    - urn: urn:intuitem:risk:req_node:ai-act:57.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.2'
      description: Additional AI regulatory sandboxes at regional or local level,
        or established jointly with the competent authorities of other Member States
        may also be established.
    - urn: urn:intuitem:risk:req_node:ai-act:57.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.3'
      description: The European Data Protection Supervisor may also establish an AI
        regulatory sandbox for Union institutions, bodies, offices and agencies, and
        may exercise the roles and the tasks of national competent authorities in
        accordance with this Chapter.
    - urn: urn:intuitem:risk:req_node:ai-act:57.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.4'
      description: Member States shall ensure that the competent authorities referred
        to in paragraphs 1 and 2 allocate sufficient resources to comply with this
        Article effectively and in a timely manner. Where appropriate, national competent
        authorities shall cooperate with other relevant authorities, and may allow
        for the involvement of other actors within the AI ecosystem. This Article
        shall not affect other regulatory sandboxes established under Union or national
        law. Member States shall ensure an appropriate level of cooperation between
        the authorities supervising those other sandboxes and the national competent
        authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:57.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.5'
      description: AI regulatory sandboxes established under paragraph (1) shall provide
        for a controlled environment that fosters innovation and facilitates the development,
        training, testing and validation of innovative AI systems for a limited time
        before their being placed on the market or put into service pursuant to a
        specific sandbox plan agreed between the prospective providers and the competent
        authority. Such regulatory sandboxes may include testing in real world conditions
        supervised in the sandbox.
    - urn: urn:intuitem:risk:req_node:ai-act:57.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.6'
      description: Competent authorities shall provide, as appropriate, guidance,
        supervision and support within the AI regulatory sandbox with a view to identifying
        risks, in particular to fundamental rights, health and safety, testing, mitigation
        measures, and their effectiveness in relation to the obligations and requirements
        of this Regulation and, where relevant, other Union and Member State law supervised
        within the sandbox.
    - urn: urn:intuitem:risk:req_node:ai-act:57.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.7'
      description: 'Competent authorities shall provide providers and prospective
        providers using the AI regulatory sandbox with guidance on regulatory expectations
        and how to fulfil the requirements and obligations set out in this Regulation.

        Upon request of the provider or prospective provider of the AI system, the
        competent authority shall provide a written proof of the activities successfully
        carried out in the sandbox. The competent authority shall also provide an
        exit report detailing the activities carried out in the sandbox and the related
        results and learning outcomes. Providers may use such documentation to demonstrate
        their compliance with this Regulation through the conformity assessment process
        or relevant market surveillance activities. In this regard, the exit reports
        and the written proof provided by the national competent authority shall be
        taken positively into account by market surveillance authorities and notified
        bodies, with a view to accelerating conformity assessment procedures to a
        reasonable extent.'
    - urn: urn:intuitem:risk:req_node:ai-act:57.8
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.8'
      description: Subject to the confidentiality provisions in Article 78, and with
        the agreement of the provider or prospective provider, the Commission and
        the Board shall be authorised to access the exit reports and shall take them
        into account, as appropriate, when exercising their tasks under this Regulation.
        If both the provider or prospective provider and the national competent authority
        explicitly agree, the exit report may be made publicly available through the
        single information platform referred to in this Article.
    - urn: urn:intuitem:risk:req_node:ai-act:57.9
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.9'
      description: 'The establishment of AI regulatory sandboxes shall aim to contribute
        to the following objectives:

        (a) improving legal certainty to achieve regulatory compliance with this Regulation
        or, where relevant, other applicable Union and national law;

        (b) supporting the sharing of best practices through cooperation with the
        authorities involved in the AI regulatory sandbox;

        (c) fostering innovation and competitiveness and facilitating the development
        of an AI ecosystem;

        (d) contributing to evidence-based regulatory learning;

        (e) facilitating and accelerating access to the Union market for AI systems,
        in particular when provided by SMEs, including start-ups.'
    - urn: urn:intuitem:risk:req_node:ai-act:57.10
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.10'
      description: National competent authorities shall ensure that, to the extent
        the innovative AI systems involve the processing of personal data or otherwise
        fall under the supervisory remit of other national authorities or competent
        authorities providing or supporting access to data, the national data protection
        authorities and those other national or competent authorities are associated
        with the operation of the AI regulatory sandbox and involved in the supervision
        of those aspects to the extent of their respective tasks and powers.
    - urn: urn:intuitem:risk:req_node:ai-act:57.11
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.11'
      description: The AI regulatory sandboxes shall not affect the supervisory or
        corrective powers of the competent authorities supervising the sandboxes,
        including at regional or local level. Any significant risks to health and
        safety and fundamental rights identified during the development and testing
        of such AI systems shall result in an adequate mitigation. National competent
        authorities shall have the power to temporarily or permanently suspend the
        testing process, or the participation in the sandbox if no effective mitigation
        is possible, and shall inform the AI Office of such decision. National competent
        authorities shall exercise their supervisory powers within the limits of the
        relevant law, using their discretionary powers when implementing legal provisions
        in respect of a specific AI sandbox project, with the objective of supporting
        innovation in AI in the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:57.12
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.12'
      description: Providers and prospective providers participating in the AI regulatory
        sandbox shall remain liable under applicable Union and national liability
        law for any damage inflicted on third parties as a result of the experimentation
        taking place in the sandbox. However, provided that the prospective providers
        observe the specific plan and the terms and conditions for their participation
        and follow in good faith the guidance given by the national competent authority,
        no administrative fines shall be imposed by the authorities for infringements
        of this Regulation. To the extent that other competent authorities responsible
        for other Union and national law were actively involved in the supervision
        of the AI system in the sandbox and provided guidance for compliance, no administrative
        fines shall be imposed regarding that law.
    - urn: urn:intuitem:risk:req_node:ai-act:57.13
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.13'
      description: The AI regulatory sandboxes shall be designed and implemented in
        such a way that, where relevant, they facilitate cross-border cooperation
        between national competent authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:57.14
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.14'
      description: 'National competent authorities  shall coordinate their activities
        and cooperate within the framework of the  Board. '
    - urn: urn:intuitem:risk:req_node:ai-act:57.15
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.15'
      description: National competent authorities shall inform the AI Office and the
        Board of the establishment of a sandbox, and may ask it for support and guidance.
        The AI Office shall make publicly available a list of planned and existing
        AI sandboxes and keep it up to date in order to encourage more interaction
        in the AI regulatory sandboxes and cross- border cooperation.
    - urn: urn:intuitem:risk:req_node:ai-act:57.16
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.16'
      description: National competent authorities shall submit to the AI Office and
        to the Board, annual reports, starting one year after the establishment of
        the AI regulatory sandbox and every year thereafter until its termination
        and a final report. Those reports shall provide information on the progress
        and results of the implementation of those sandboxes, including best practices,
        incidents, lessons learnt and recommendations on their setup and, where relevant,
        on the application and possible revision of this Regulation, including its
        delegated and implementing acts, and on the application of other Union law
        supervised by the competent authorities within the sandbox. The national competent
        authorities shall make those annual reports or abstracts thereof available
        to the public, online. The Commission shall, where appropriate, take the annual
        reports into account when exercising its tasks under this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:57.17
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node781
      ref_id: '57.17'
      description: The Commission shall develop a single and dedicated interface containing
        all relevant information related to AI regulatory sandboxes to allow stakeholders
        to interact with AI regulatory sandboxes and to raise enquiries with competent
        authorities, and to seek non- binding guidance on the conformity of innovative
        products, services, business models embedding AI technologies, in accordance
        with Article 62(1), point (c). The Commission shall proactively coordinate
        with national competent authorities, where relevant.
    - urn: urn:intuitem:risk:req_node:ai-act:node799
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 58
      description: Detailed arrangements for and functioning of AI regulatory sandboxes
    - urn: urn:intuitem:risk:req_node:ai-act:58.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node799
      ref_id: '58.1'
      description: 'In order to avoid fragmentation across the Union, the Commission
        shall adopt implementing acts specifying the detailed arrangements for the
        establishment, development, implementation, operation and supervision of the
        AI regulatory sandboxes. The implementing acts shall include common principles
        on the following issues:

        (a) eligibility and selection criteria for participation in the AI regulatory
        sandbox;

        (b) procedures for the application, participation, monitoring, exiting from
        and termination of the AI regulatory sandbox, including the sandbox plan and
        the exit report;

        (c) the terms and conditions applicable to the participants.

        Those implementing acts shall be adopted in accordance with the examination
        procedure referred to in Article 98(2).'
    - urn: urn:intuitem:risk:req_node:ai-act:58.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node799
      ref_id: '58.2'
      description: 'The implementing acts referred to in paragraph 1 shall ensure
        that:

        (a) AI regulatory sandboxes are open to any applying prospective provider
        of an AI system who fulfils eligibility and selection criteria, which shall
        be transparent and fair and national competent authorities inform applicants
        of their decision within three months of the application;

        (g) procedures, processes and administrative requirements for application,
        selection, participation and exiting the AI regulatory sandbox are simple,
        easily intelligible, and clearly communicated in order to facilitate the participation
        of SMEs, including start-ups, with limited legal and administrative capacities
        and are streamlined across the Union, in order to avoid fragmentation and
        that participation in an AI regulatory sandbox established by a Member State,
        or by the European Data Protection Supervisor is mutually and uniformly recognised
        and carries the same legal effects across the Union;

        (h) participation in the AI regulatory sandbox is limited to a period that
        is appropriate to the complexity and scale of the project, which may be extended
        by the national competent authority;

        (i) AI regulatory sandboxes facilitate the development of tools and infrastructure
        for testing, benchmarking, assessing and explaining dimensions of AI systems
        relevant for regulatory learning, such as accuracy, robustness and cybersecurity,
        as well as measures to mitigate risks to fundamental rights and society at
        large.

        (b) AI regulatory sandboxes allow broad and equal access and keep up with
        demand for participation; prospective providers may also submit applications
        in partnerships with users and other relevant third parties;

        (c) the detailed arrangements for and conditions concerning AI regulatory
        sandboxes to the best extent possible support flexibility for national competent
        authorities to establish and operate their AI regulatory sandboxes;

        (d) access to the AI regulatory sandboxes is free of charge for SMEs, including
        start- ups, without prejudice to exceptional costs that national competent
        authorities may recover in a fair and proportionate manner;

        (e) they facilitate prospective providers, by means of the learning outcomes
        of the AI regulatory sandboxes, in complying with conformity assessment obligations
        under this Regulation and the voluntary application of the codes of conduct
        referred to in Article 95;

        (f) AI regulatory sandboxes facilitate the involvement of other relevant actors
        within the AI ecosystem, such as notified bodies and standardisation organisations,
        SMEs, start-ups, enterprises, innovators, testing and experimentation facilities,
        research and experimentation labs and European Digital Innovation Hubs, centres
        of excellence, individual researchers, in order to allow and facilitate cooperation
        with the public and private sectors;'
    - urn: urn:intuitem:risk:req_node:ai-act:58.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node799
      ref_id: '58.3'
      description: Prospective providers in the AI regulatory sandboxes, in particular
        SMEs and start-ups, shall be directed, where relevant, to pre-deployment services
        such as guidance on the implementation of this Regulation, to other value-adding
        services such as help with standardisation documents and certification, testing
        and experimentation facilities, European Digital Innovation Hubs and centres
        of excellence.
    - urn: urn:intuitem:risk:req_node:ai-act:58.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node799
      ref_id: '58.4'
      description: Where national competent authorities consider authorising testing
        in real world conditions supervised within the framework of an AI regulatory
        sandbox to be established under this Article, they shall specifically agree
        with the participants on the terms and conditions of such testing and in particular
        on the appropriate safeguards with a view to protecting fundamental rights,
        health and safety. Where appropriate, they shall cooperate with other national
        competent authorities with a view to ensuring consistent practices across
        the Union.
    - urn: urn:intuitem:risk:req_node:ai-act:node804
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 59
      description: Further processing of personal data for developing certain AI systems
        in the public interest in the AI regulatory sandbox
    - urn: urn:intuitem:risk:req_node:ai-act:59.1
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node804
      ref_id: '59.1'
      description: 'Personal data lawfully collected for other purposes may be processed
        in an AI regulatory sandbox solely for the purpose of developing, training
        and testing certain  AI systems in the sandbox when all of the following conditions
        are met:'
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.a
      description: 'AI systems shall be developed for safeguarding substantial public
        interest by a public authority or another natural or legal person and in one
        or more of the following areas:'
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a.i
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      ref_id: 59.1.a.i
      description: public safety and public health, including disease detection, diagnosis
        prevention, control and treatment and improvement of health care systems;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a.ii
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      ref_id: 59.1.a.ii
      description: a high level of protection and improvement of the quality of the
        environment, protection of biodiversity, protection against pollution, green
        transition measures, climate change mitigation and adaptation measures;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a.iii
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      ref_id: 59.1.a.iii
      description: energy sustainability;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a.iv
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      ref_id: 59.1.a.iv
      description: safety and resilience of transport systems and mobility, critical
        infrastructure and networks;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.a.v
      assessable: false
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1.a
      ref_id: 59.1.a.v
      description: efficiency and quality of public administration and public services;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.b
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.b
      description: the data processed are necessary for complying with one or more
        of the requirements referred to in Chapter III, Section 2 where those requirements
        cannot effectively be fulfilled by processing anonymised, synthetic or other
        non-personal data;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.c
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.c
      description: 'there are effective monitoring mechanisms to identify if any high
        risks to the rights and freedoms of the data subjects, as referred to in Article
        35 of Regulation

        (EU) 2016/679 and in Article 39 of Regulation (EU) 2018/1725, may arise during
        the sandbox experimentation, as well as response mechanisms to promptly mitigate
        those risks and, where necessary, stop the processing;'
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.d
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.d
      description: any personal data to be processed in the context of the sandbox
        are in a functionally separate, isolated and protected data processing environment
        under the control of the prospective provider and only authorised persons
        have access to those data;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.e
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.e
      description: providers can further share the originally collected data only
        in compliance with Union data protection law; any personal data crated in
        the sandbox cannot be shared outside the sandbox;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.f
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.f
      description: any processing of personal data in the context of the sandbox neither
        leads to measures or decisions affecting the data subjects nor does it affect
        the application of their rights laid down in Union law on the protection of
        personal data;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.g
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.g
      description: any personal data processed in the context of the sandbox are protected
        by means of appropriate technical and organisational measures and deleted
        once the participation in the sandbox has terminated or the personal data
        has reached the end of its retention period;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.h
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.h
      description: the logs of the processing of personal data in the context of the
        sandbox are kept for the duration of the participation in the sandbox, unless
        provided otherwise by Union or national law;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.i
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.i
      description: a complete and detailed description of the process and rationale
        behind the training, testing and validation of the AI system is kept together
        with the testing results as part of the technical documentation referred to
        in Annex IV;
    - urn: urn:intuitem:risk:req_node:ai-act:59.1.j
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: 59.1.j
      description: a short summary of the AI project developed in the sandbox, its
        objectives and expected results is published on the website of the competent
        authorities; this obligation shall not cover sensitive operational data in
        relation to the activities of law enforcement, border control, immigration
        or asylum authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:59.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: '59.2'
      description: For the purposes of the prevention, investigation, detection or
        prosecution of criminal offences or the execution of criminal penalties, including
        safeguarding against and preventing prevention threats to public security,
        under the control and responsibility of law enforcement authorities, the processing
        of personal data in AI regulatory sandboxes shall be based on a specific or
        Union or national law and subject to the same cumulative conditions as referred
        to in paragraph 1.
    - urn: urn:intuitem:risk:req_node:ai-act:59.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:59.1
      ref_id: '59.3'
      description: Paragraph 1 is without prejudice to Union or national law which
        excludes processing of personal data for other purposes than those explicitly
        mentioned in that law, as well as to Union or national law laying down the
        basis for the processing of personal data which is necessary for the purpose
        of developing, testing or training of innovative AI systems or any other legal
        basis, in compliance with Union law on the protection of personal data.
    - urn: urn:intuitem:risk:req_node:ai-act:node823
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 60
      description: Testing of high-risk AI systems in real world conditions outside
        AI regulatory sandboxes
    - urn: urn:intuitem:risk:req_node:ai-act:60.1
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.1'
      description: Testing of high-risk AI systems in real world conditions outside
        AI regulatory sandboxes may be conducted by providers or prospective providers
        of high-risk AI systems listed in Annex III, in accordance with this Article
        and the real-world testing plan referred to in this Article, without prejudice
        to the prohibitions under Article 5.
    - urn: urn:intuitem:risk:req_node:ai-act:node825
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      description: 'The detailed elements of the real-world testing plan shall be
        specified in implementing acts adopted by the Commission in accordance with
        the examination procedure referred to in Article 98(2).

        This provision shall be without prejudice to Union or national law on the
        testing in real world conditions of high-risk AI systems related to products
        covered by Union harmonisation legislation listed in Annex I.'
    - urn: urn:intuitem:risk:req_node:ai-act:60.2
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.2'
      description: Providers or prospective providers may conduct testing of high-risk
        AI systems referred to in Annex III in real world conditions at any time before
        the placing on the market or the putting into service of the AI system on
        their own or in partnership with one or more prospective deployers.
    - urn: urn:intuitem:risk:req_node:ai-act:60.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.3'
      description: The testing of high-risk AI systems in real world conditions under
        this Article shall be without prejudice to any ethical review that is required
        by Union or national law.
    - urn: urn:intuitem:risk:req_node:ai-act:60.4
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.4'
      description: 'Providers or prospective providers may conduct the testing in
        real world conditions only where all of the following conditions are met:'
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.a
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.a
      description: the provider or prospective provider has drawn up a real-world
        testing plan and submitted it to the market surveillance authority in the
        Member State where the testing in real world conditions is to be conducted;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.b
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.b
      description: the market surveillance authority in the Member State where the
        testing in real world conditions is to be conducted has approved the testing
        in real world conditions and the real-world testing plan. Where the market
        surveillance authority has not provided an answer within 30 days, the testing
        in real world conditions and the real-world testing plan shall be understood
        to have been approved. Where national law does not provide for a tacit approval,
        the testing in real world conditions shall remain subject to an authorisation;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.c
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.c
      description: the provider or prospective provider, with the exception of providers
        or prospective providers of high-risk AI systems referred to in points 1,
        6 and 7 of Annex III in the areas of law enforcement, migration, asylum and
        border control management, and high-risk AI systems referred to in point 2
        of Annex III has registered the testing in real world conditions in the non-public
        part of the EU database referred to in Article 71(3) with a Union-wide unique
        single identification number and with the information specified in Annex IX;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.d
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.d
      description: the provider or prospective provider conducting the testing in
        real world conditions is established in the Union or has appointed a legal
        representative who is established in the Union;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.e
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.e
      description: data collected and processed for the purpose of the testing in
        real world conditions shall be transferred to third countries only provided
        that appropriate and applicable safeguards under Union law are implemented;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.f
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.f
      description: the testing in real world conditions does not last longer than
        necessary to achieve its objectives and in any case not longer than six months,
        which may be extended for an additional period of six months, subject to prior
        notification by the provider to the market surveillance authority, accompanied
        by an explanation of the need for such an extension;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.g
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.g
      description: subjects of the testing in real world conditions who are vulnerable
        persons due to their age, physical or mental disability, are appropriately
        protected;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.h
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.h
      description: where a provider or prospective provider organises the testing
        in real world conditions in cooperation with one or more deployers or prospective
        deployers, the latter have been informed of all aspects of the testing that
        are relevant to their decision to participate, and given the relevant instructions
        for use of the AI system referred to in Article 13; the provider or prospective
        provider and the prospective deployer shall conclude an agreement specifying
        their roles and responsibilities with a view to ensuring compliance with the
        provisions for testing in real world conditions under this Regulation and
        under other applicable Union and national law;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.i
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.i
      description: the subjects of the testing in real world conditions have given
        informed consent in accordance with Article 61, or in the case of law enforcement,
        where the seeking of informed consent would prevent the AI system from being
        tested, the testing itself and the outcome of the testing in the real world
        conditions shall not have any negative effect on the subjects, and their personal
        data shall be deleted after the test is performed;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.j
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.j
      description: the testing in real world conditions is effectively overseen by
        the provider or prospective provider, as well as by deployers or prospective
        deployers through persons who are suitably qualified in the relevant field
        and have the necessary capacity, training and authority to perform their tasks;
    - urn: urn:intuitem:risk:req_node:ai-act:60.4.k
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:60.4
      ref_id: 60.4.k
      description: the predictions, recommendations or decisions of the AI system
        can be effectively reversed and disregarded.
    - urn: urn:intuitem:risk:req_node:ai-act:60.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.5'
      description: Any subjects of the testing in real world conditions, or their
        legally designated representative, as appropriate, may, without any resulting
        detriment and without having to provide any justification, withdraw from the
        testing at any time by revoking their informed consent and may request the
        immediate and permanent deletion of their personal data. The withdrawal of
        the informed consent shall not affect the lawfulness or validity of activities
        already carried out.
    - urn: urn:intuitem:risk:req_node:ai-act:60.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.6'
      description: In accordance with Article 75, Member States shall confer on their
        market surveillance authorities the powers of requiring providers and prospective
        providers to provide information, of carrying out unannounced remote or on-site
        inspections, and of performing checks on the development of the testing in
        real world conditions and the related products. Market surveillance authorities
        shall use those powers to ensure the safe development of testing in real world
        conditions.
    - urn: urn:intuitem:risk:req_node:ai-act:60.7
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.7'
      description: Any serious incident identified in the course of the testing in
        real world conditions shall be reported to the national market surveillance
        authority in accordance with Article 73. The provider or prospective provider
        shall adopt immediate mitigation measures or, failing that, shall suspend
        the testing in real world conditions until such mitigation takes place, or
        otherwise terminate it. The provider or prospective provider shall establish
        a procedure for the prompt recall of the AI system upon such termination of
        the testing in real world conditions.
    - urn: urn:intuitem:risk:req_node:ai-act:60.8
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.8'
      description: Providers or prospective providers shall notify the national market
        surveillance authority in the Member State where the testing in real world
        conditions is to be conducted of the suspension or termination of the testing
        in real world conditions and of the final outcomes.
    - urn: urn:intuitem:risk:req_node:ai-act:60.9
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node823
      ref_id: '60.9'
      description: The provider or prospective provider shall be liable under applicable
        Union and national liability law for any damage caused in the course of their
        testing in real world conditions.
    - urn: urn:intuitem:risk:req_node:ai-act:node845
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 61
      description: Informed consent to participate in testing in real world conditions
        outside AI regulatory sandboxes
    - urn: urn:intuitem:risk:req_node:ai-act:61.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node845
      ref_id: '61.1'
      description: 'For the purpose of testing in real world conditions under Article
        60, freely-given informed consent shall obtained from the subjects of testing
        prior to their participation in such testing and after their having been duly
        informed with concise, clear, relevant, and understandable information regarding:'
    - urn: urn:intuitem:risk:req_node:ai-act:61.1.a
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:61.1
      ref_id: 61.1.a
      description: the nature and objectives of the testing in real world conditions
        and the possible inconvenience that may be linked to their participation;
    - urn: urn:intuitem:risk:req_node:ai-act:61.1.b
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:61.1
      ref_id: 61.1.b
      description: the conditions under which the testing in real world conditions
        is to be conducted, including the expected duration of the subject or subjects'
        participation;
    - urn: urn:intuitem:risk:req_node:ai-act:61.1.c
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:61.1
      ref_id: 61.1.c
      description: their rights, and the guarantees regarding their participation,
        in particular their right to refuse to participate in, and the right to withdraw
        from, testing in real world conditions at any time without any resulting detriment
        and without having to provide any justification;
    - urn: urn:intuitem:risk:req_node:ai-act:61.1.d
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:61.1
      ref_id: 61.1.d
      description: the arrangements for requesting the reversal or the disregard of
        the predictions, recommendations or decisions of the AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:61.1.e
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:61.1
      ref_id: 61.1.e
      description: the Union-wide unique single identification number of the testing
        in real world conditions in accordance with Article 60(4) point (c), and the
        contact details of the provider or its legal representative from whom further
        information can be obtained.
    - urn: urn:intuitem:risk:req_node:ai-act:61.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node845
      ref_id: '61.2'
      description: The informed consent shall be dated and documented and a copy shall
        be given to the subjects of testing or their legal representative.
    - urn: urn:intuitem:risk:req_node:ai-act:node853
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 62
      description: Measures for providers and deployers, in particular SMEs, including
        start-ups
    - urn: urn:intuitem:risk:req_node:ai-act:62.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node853
      ref_id: '62.1'
      description: 'Member States shall undertake the following actions:

        (a) provide SMEs, including start-ups, having a registered office or a branch
        in the Union, with priority access to the AI regulatory sandboxes, to the
        extent that they fulfil the eligibility conditions and selection criteria.
        The priority access shall not preclude other SMEs including start-ups other
        than those referred to in the first subparagraph from access to the AI regulatory
        sandbox, provided that they also fulfil the eligibility conditions and selection
        criteria;

        (b) organise specific awareness raising and training activities on the application
        of this Regulation tailored to the needs of SMEs including start-ups, users
        and, as appropriate, local public authorities;

        (c) utilise existing dedicated channels and where appropriate, establish new
        ones for communication with SMEs including start-ups, users, other innovators
        and, as appropriate, local public authorities to provide advice and respond
        to queries about the implementation of this Regulation, including as regards
        participation in AI regulatory sandboxes;

        (d) facilitate the participation of SMEs and other relevant stakeholders in
        the standardisation development process.'
    - urn: urn:intuitem:risk:req_node:ai-act:62.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node853
      ref_id: '62.2'
      description: The specific interests and needs of the SME providers, including
        start-ups, shall be taken into account when setting the fees for conformity
        assessment under Article 43, reducing those fees proportionately to their
        size, market size and other relevant indicators.
    - urn: urn:intuitem:risk:req_node:ai-act:62.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node853
      ref_id: '62.3'
      description: 'The AI Office shall undertake the following actions:

        (a) provide standardised templates for areas covered by this Regulation, as
        specified by the Board in its reasoned request;

        (b) develop and maintain a single information platform providing easy to use
        information in relation to this Regulation for all operators across the Union;

        (c) organise appropriate communication campaigns to raise awareness about
        the obligations arising from this Regulation;

        (d) evaluate and promote the convergence of best practices in public procurement
        procedures in relation to AI systems.'
    - urn: urn:intuitem:risk:req_node:ai-act:node857
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node780
      name: Article 63
      description: Derogations for specific operators
    - urn: urn:intuitem:risk:req_node:ai-act:63.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node857
      ref_id: '63.1'
      description: Microenterprises within the meaning of Recommendation 2003/361/EC,
        may comply with certain elements of the quality management system required
        by Article 17 of this Regulation in a simplified manner, provided that they
        do not have partner enterprises or linked enterprises within the meaning of
        that Recommendation. For that purpose, the Commission shall develop guidelines
        on the elements of the quality management system which may be complied with
        in a simplified manner considering the needs of microenterprises, without
        affecting the level of protection or the need for compliance with the requirements
        in respect of high-risk AI systems.
    - urn: urn:intuitem:risk:req_node:ai-act:63.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node857
      ref_id: '63.2'
      description: Paragraph 1 of this Article shall not be interpreted as exempting
        those operators from fulfilling any other requirements or obligations laid
        down in this Regulation, including those established in Articles 9, 10, 11,
        12, 13, 14, 15, 72 and 73.
    - urn: urn:intuitem:risk:req_node:ai-act:node860
      assessable: false
      depth: 1
      name: 'CHAPTER VII '
      description: GOVERNANCE
    - urn: urn:intuitem:risk:req_node:ai-act:node861
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node860
      name: 'Section 1 '
      description: Governance at Union level
    - urn: urn:intuitem:risk:req_node:ai-act:node862
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: Article 64
      description: AI Office
    - urn: urn:intuitem:risk:req_node:ai-act:64.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node862
      ref_id: '64.1'
      description: The Commission shall develop Union expertise and capabilities in
        the field of AI through the AI Office.
    - urn: urn:intuitem:risk:req_node:ai-act:64.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node862
      ref_id: '64.2'
      description: Member States shall facilitate the tasks entrusted to the AI Office,
        as reflected in this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node865
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: Article 65
      description: Establishment and structure of the European Artificial Intelligence
        Board
    - urn: urn:intuitem:risk:req_node:ai-act:65.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.1'
      description: "A European Artificial Intelligence Board (the \u2018Board\u2019\
        ) is hereby established."
    - urn: urn:intuitem:risk:req_node:ai-act:65.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.2'
      description: "The Board shall be composed of one representative per Member State.\
        \ The European Data Protection Supervisor shall participate as observer. The\
        \ AI Office shall also attend the Board\u2019s meetings, without taking part\
        \ in the votes. Other national and Union authorities, bodies or experts may\
        \ be invited to the meetings by the Board on a case by case basis, where the\
        \ issues discussed are of relevance for them."
    - urn: urn:intuitem:risk:req_node:ai-act:65.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.3'
      description: Each representative shall be designated by their Member State for
        a period of three years, renewable once.
    - urn: urn:intuitem:risk:req_node:ai-act:65.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.4'
      description: "Member States shall ensure that their representatives on the Board:\n\
        (a) have the relevant competences and powers in their Member State so as to\
        \ contribute actively to the achievement of the Board\u2019s tasks referred\
        \ to in Article 66;\n(b) are designated as a single contact point vis-\xE0\
        -vis the Board and, where appropriate, taking into account Member States\u2019\
        \ needs, as a single contact point for stakeholders;\n(c) are empowered to\
        \ facilitate consistency and coordination between national competent authorities\
        \ in their Member State as regards the implementation of this Regulation,\
        \ including through the collection of relevant data and information for the\
        \ purpose of fulfilling their tasks on the Board."
    - urn: urn:intuitem:risk:req_node:ai-act:65.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.5'
      description: "The designated representatives of the Member States shall adopt\
        \ the Board\u2019s rules of procedure by a two-thirds majority. The rules\
        \ of procedure shall, in particular, lay down procedures for the selection\
        \ process, the duration of the mandate of, and specifications of the tasks\
        \ of, the Chair, detailed arrangements for voting, and the organisation of\
        \ the Board\u2019s activities and those of its sub-groups."
    - urn: urn:intuitem:risk:req_node:ai-act:65.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.6'
      description: 'The Board shall establish two standing sub-groups to provide a
        platform for cooperation and exchange among market surveillance authorities
        and to notify authorities about issues related to market surveillance and
        notified bodies.

        The standing sub-group for market surveillance should act as the administrative
        cooperation group (ADCO) for this Regulation within the meaning of Article
        30 of Regulation (EU) 2019/1020.

        The Board may establish other standing or temporary sub-groups as appropriate
        for the purpose of examining specific issues. Where appropriate, representatives
        of the advisory forum referred to in Article 67 may be invited to such sub-groups
        or to specific meetings of those subgroups as observers.'
    - urn: urn:intuitem:risk:req_node:ai-act:65.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.7'
      description: The Board shall be organised and operated so as to safeguard the
        objectivity and impartiality of its activities.
    - urn: urn:intuitem:risk:req_node:ai-act:65.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node865
      ref_id: '65.8'
      description: The Board shall be chaired by one of the representatives of the
        Member States. The AI Office shall provide the secretariat for the Board.
        convene the meetings upon request of the Chair, and prepare the agenda in
        accordance with the tasks of the Board pursuant to this Regulation and its
        rules of procedure.
    - urn: urn:intuitem:risk:req_node:ai-act:node874
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: Article 66
      description: Tasks of the Board
    - urn: urn:intuitem:risk:req_node:ai-act:node875
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node874
      description: "The Board shall advise and assist the Commission and the Member\
        \ States in order to facilitate the consistent and effective application of\
        \ this Regulation. For this purpose, the Board may in particular:(a) contribute\
        \ to the coordination among national competent authorities responsible for\
        \ the application of this Regulation and, in cooperation with and subject\
        \ to the agreement of the market surveillance authorities concerned, support\
        \ joint activities of market surveillance authorities referred to in Article\
        \ 74(11);\n(iii) on technical specifications or existing standards regarding\
        \ the requirements set out in Chapter III, Section 2;\n(iv) on the use of\
        \ harmonised standards or common specifications referred to in Articles 40\
        \ and 41;\n(v) trends, such as European global competitiveness in AI, the\
        \ uptake of AI in the Union, and the development of digital skills;\n(vi)\
        \ trends on the evolving typology of AI value chains, in particular on the\
        \ resulting implications in terms of accountability;\n(vii) on the potential\
        \ need for amendment to Annex III in accordance with Article 7, and on the\
        \ potential need for possible revision of Article 5 pursuant to Article 112,\
        \ taking into account relevant available evidence and the latest developments\
        \ in technology;\n(f) support the Commission in promoting AI literacy, public\
        \ awareness and understanding of the benefits, risks, safeguards and rights\
        \ and obligations in relation to the use of AI systems;\n(g) facilitate the\
        \ development of common criteria and a shared understanding among market operators\
        \ and competent authorities of the relevant concepts provided for in this\
        \ Regulation, including by contributing to the development of benchmarks;\n\
        (h) cooperate, as appropriate, with other Union institutions, bodies, offices\
        \ and agencies, as well as relevant Union expert groups and networks, in particular\
        \ in the fields of product safety, cybersecurity, competition, digital and\
        \ media services, financial services, consumer protection, data and fundamental\
        \ rights protection;\n(i) contribute to effective cooperation with the competent\
        \ authorities of third countries and with international organisations;\n(j)\
        \ assist national competent authorities and the Commission in developing the\
        \ organisational and technical expertise required for the implementation of\
        \ this Regulation, including by contributing to the assessment of training\
        \ needs for staff of Member States involved in implementing this Regulation;\n\
        (k) assist the AI Office in supporting national competent authorities in the\
        \ establishment and development of regulatory sandboxes, and facilitate cooperation\
        \ and information- sharing among regulatory sandboxes;\n(l) contribute to,\
        \ and provide relevant advice on, the development of guidance documents;\n\
        (m) advise the Commission in relation to international matters on AI;\n(n)\
        \ provide opinions to the Commission on the qualified alerts regarding general-purpose\
        \ AI models;\n(o) receive opinions by the Member States on qualified alerts\
        \ regarding general-purpose AI models, and on national experiences and practices\
        \ on the monitoring and enforcement of AI systems, in particular systems integrating\
        \ the general-purpose AI models.\n(b) collect and share technical and regulatory\
        \ expertise and best practices among Member States;\n(c) provide advice on\
        \ the implementation of this Regulation, in particular as regards the enforcement\
        \ of rules on general-purpose AI models;\n(d) contribute to the harmonisation\
        \ of administrative practices in the Member States, including in relation\
        \ to the derogation from the conformity assessment procedures referred to\
        \ in Article 46, the functioning of regulatory sandboxes, and testing in real\
        \ world conditions referred to in Articles 57, 59 and 60;\n(e) upon the request\
        \ of the Commission or on its own initiative, issue recommendations and written\
        \ opinions on any relevant matters related to the implementation of this Regulation\
        \ and to its consistent and effective application, including:\n(i) on the\
        \ development and application of codes of conduct and codes of practice pursuant\
        \ to this Regulation, as well as of the Commission\u2019s guidelines;\n(ii)\
        \ the evaluation and review of this Regulation pursuant to Article 112, including\
        \ as regards the serious incident reports referred to in Article 73, and the\
        \ functioning of the database referred to in Article 71, the preparation of\
        \ the delegated or implementing acts, and as regards possible alignments of\
        \ this Regulation with the legal acts listed in Annex I;"
    - urn: urn:intuitem:risk:req_node:ai-act:node876
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: 'Article 67 '
      description: Advisory forum
    - urn: urn:intuitem:risk:req_node:ai-act:67.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.1'
      description: An advisory forum shall be established to provide technical expertise
        and advise the Board and the Commission, and to contribute to their tasks
        under this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:67.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.2'
      description: The membership of the advisory forum shall represent a balanced
        selection of stakeholders, including industry, start-ups, SMEs, civil society
        and academia. The membership of the advisory forum shall be balanced with
        regard to commercial and non-commercial interests and, within the category
        of commercial interests, with regard to SMEs and other undertakings.
    - urn: urn:intuitem:risk:req_node:ai-act:67.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.3'
      description: The Commission shall appoint the members of the advisory forum,
        in accordance with the criteria set out in paragraph 2, from amongst stakeholders
        with recognised expertise in the field of AI.
    - urn: urn:intuitem:risk:req_node:ai-act:67.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.4'
      description: The term of office of the members of the advisory forum shall be
        two years, which may be extended by up to no more than four years.
    - urn: urn:intuitem:risk:req_node:ai-act:67.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.5'
      description: The Fundamental Rights Agency, ENISA, the European Committee for
        Standardization (CEN), the European Committee for Electrotechnical Standardization
        (CENELEC), and the European Telecommunications Standards Institute (ETSI)
        shall be permanent members of the advisory forum.
    - urn: urn:intuitem:risk:req_node:ai-act:67.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.6'
      description: The advisory forum shall draw up its rules of procedure. It shall
        elect two co-chairs from among its members, in accordance with criteria set
        out in paragraph 2. The term of office of the co-chairs shall be two years,
        renewable once.
    - urn: urn:intuitem:risk:req_node:ai-act:67.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.7'
      description: The advisory forum shall hold meetings at least twice a year. The
        advisory forum may invite experts and other stakeholders to its meetings
    - urn: urn:intuitem:risk:req_node:ai-act:67.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.8'
      description: The advisory forum may prepare opinions, recommendations and written
        contributions upon request of the Board or the Commission.
    - urn: urn:intuitem:risk:req_node:ai-act:67.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.9'
      description: The advisory forum may establish standing or temporary sub-groups
        as appropriate for the purpose of examining specific questions related to
        the objectives of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:67.10
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node876
      ref_id: '67.10'
      description: The advisory forum shall prepare an annual report on its activities.
        That report shall be made publicly available.
    - urn: urn:intuitem:risk:req_node:ai-act:node887
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: Article 68
      description: 'Scientific panel of independent experts '
    - urn: urn:intuitem:risk:req_node:ai-act:68.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node887
      ref_id: '68.1'
      description: "The Commission shall, by means of an implementing act, make provisions\
        \ on the establishment of a scientific panel of independent experts (the \u2018\
        scientific panel\u2019) intended to support the enforcement activities under\
        \ this Regulation. That implementing act shall be adopted in accordance with\
        \ the examination procedure referred to in Article 98(2)."
    - urn: urn:intuitem:risk:req_node:ai-act:68.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node887
      ref_id: '68.2'
      description: 'The scientific panel shall consist of experts selected by the
        Commission on the basis of up-to-date scientific or technical expertise in
        the field of AI necessary for the tasks set out in paragraph 3, and shall
        be able to demonstrate meeting all of the following conditions:

        (a) having particular expertise and competence and scientific or technical
        expertise in the field of AI;

        (b) independence from any provider of AI systems or general-purpose AI models
        or systems;

        (c) an ability to carry out activities diligently, accurately and objectively.
        The Commission, in consultation with the Board, shall determine the number
        of experts on the panel in accordance with the required needs and shall ensure
        fair gender and geographical representation.'
    - urn: urn:intuitem:risk:req_node:ai-act:68.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node887
      ref_id: '68.3'
      description: 'The scientific panel shall advise and support the AI Office, in
        particular with regard to the following tasks:

        (a) supporting the implementation and enforcement of this Regulation as regards
        general-purpose AI models and systems, in particular by:

        (i) alerting the AI Office of possible systemic risks at Union level of general-
        purpose AI models, in accordance with Article 90;

        (ii) contributing to the development of tools and methodologies for evaluating
        capabilities of general-purpose AI models and systems, including through benchmarks;

        (iii) providing advice on the classification of general-purpose AI models
        with systemic risk;

        (iv) providing advice on the classification of various general-purpose AI
        models and systems;

        (v) contributing to the development of tools and templates;

        (b) supporting the work of market surveillance authorities, at their request;

        (c) supporting cross-border market surveillance activities as referred to
        in

        Article 74(11), without prejudice to the powers of market surveillance authorities;

        (d) supporting the AI Office in carrying out its duties in the context of
        the safeguard clause pursuant to Article 81.'
    - urn: urn:intuitem:risk:req_node:ai-act:68.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node887
      ref_id: '68.4'
      description: The experts on the scientific panel shall perform their tasks with
        impartiality and objectivity, and shall ensure the confidentiality of information
        and data obtained in carrying out their tasks and activities. They shall neither
        seek nor take instructions from anyone when exercising their tasks under paragraph
        3. Each expert shall draw up a declaration of interests, which shall be made
        publicly available. The AI Office shall establish systems and procedures to
        actively manage and prevent potential conflicts of interest.
    - urn: urn:intuitem:risk:req_node:ai-act:68.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node887
      ref_id: '68.5'
      description: The implementing act referred to in paragraph 1 shall include provisions
        on the conditions, procedures and detailed arrangements for the scientific
        panel and its members to issue alerts, and to request the assistance of the
        AI Office for the performance of the tasks of the scientific panel.
    - urn: urn:intuitem:risk:req_node:ai-act:node893
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node861
      name: Article 69
      description: Access to the pool of experts by the Member States
    - urn: urn:intuitem:risk:req_node:ai-act:69.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node893
      ref_id: '69.3'
      description: Member States may call upon experts of the scientific panel to
        support their enforcement activities under this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:69.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node893
      ref_id: '69.4'
      description: The Member States may be required to pay fees for the advice and
        support provided by the experts. The structure and the level of fees as well
        as the scale and structure of recoverable costs shall be set out in the implementing
        act referred to in Article 68(1), taking into account the objectives of the
        adequate implementation of this Regulation, cost-effectiveness and the necessity
        of ensuring effective access to experts for all Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:69.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node893
      ref_id: '69.5'
      description: The Commission shall facilitate timely access to the experts by
        the Member States, as needed, and ensure that the combination of support activities
        carried out by Union AI testing support pursuant to Article 84 and experts
        pursuant to this Article is efficiently organised and provides the best possible
        added value.
    - urn: urn:intuitem:risk:req_node:ai-act:node897
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node860
      name: Section 2
      description: National competent authorities
    - urn: urn:intuitem:risk:req_node:ai-act:node898
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node897
      name: Article 70
      description: Designation of national competent authorities and single point
        of contact
    - urn: urn:intuitem:risk:req_node:ai-act:70.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.1'
      description: Each Member State shall establish or designate as national competent
        authorities at least one notifying authority and at least one market surveillance
        authority for the purposes of this Regulation. Those national competent authorities
        shall exercise their powers independently, impartially and without bias so
        as to safeguard the objectivity of their activities and tasks, and to ensure
        the application and implementation of this Regulation. The members of those
        authorities shall refrain from any action incompatible with their duties.
        Provided that those principles are observed, such activities and tasks may
        be performed by one or more designated authorities, in accordance with the
        organisational needs of the Member State.
    - urn: urn:intuitem:risk:req_node:ai-act:70.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.2'
      description: Member States shall communicate to the Commission the identity
        of the notifying authorities and the market surveillance authorities and the
        tasks of those authorities, as well as any subsequent changes thereto. Member
        States shall make publicly available information on how competent authorities
        and single points of contact can be contacted, through electronic communication
        means by 2 August 2025. Member States shall designate a market surveillance
        authority to act as the single point of contact for this Regulation, and shall
        notify the Commission of the identity of the single point of contact. The
        Commission shall make a list of the single points of contact publicly available.
    - urn: urn:intuitem:risk:req_node:ai-act:70.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.3'
      description: Member States shall ensure that their national competent authorities
        are provided with adequate technical, financial and human resources, and with
        infrastructure to fulfil their tasks effectively under this Regulation. In
        particular, the national competent authorities shall have a sufficient number
        of personnel permanently available whose competences and expertise shall include
        an in-depth understanding of AI technologies, data and data computing, personal
        data protection, cybersecurity, fundamental rights, health and safety risks
        and knowledge of existing standards and legal requirements. Member States
        shall assess and, if necessary, update competence and resource requirements
        referred to in this paragraph on an annual basis.
    - urn: urn:intuitem:risk:req_node:ai-act:70.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.4'
      description: National competent authorities shall take an adequate level of
        cybersecurity measures.
    - urn: urn:intuitem:risk:req_node:ai-act:70.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.5'
      description: When performing their tasks, the national competent authorities
        shall act in compliance with the confidentiality obligations set out in Article
        78.
    - urn: urn:intuitem:risk:req_node:ai-act:70.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.6'
      description: By 2 August 2025, and once every two years thereafter, Member States
        shall report to the Commission on the status of the financial and human resources
        of the national competent authorities, with an assessment of their adequacy.
        The Commission shall transmit that information to the Board for discussion
        and possible recommendations.
    - urn: urn:intuitem:risk:req_node:ai-act:70.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.7'
      description: The Commission shall facilitate the exchange of experience between
        national competent authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:70.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.8'
      description: 'National competent authorities may provide guidance and advice
        on the implementation of this Regulation, in particular to SMEs including
        start-ups, taking into account the guidance and advice of the Board and the
        Commission, as appropriate. Whenever national competent authorities intend
        to provide guidance and advice with regard to an AI system in areas covered
        by other Union law, the competent national authorities under that Union law
        shall be consulted, as appropriate. '
    - urn: urn:intuitem:risk:req_node:ai-act:70.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node898
      ref_id: '70.9'
      description: Where Union institutions, bodies, offices or agencies fall within
        the scope of this Regulation, the European Data Protection Supervisor shall
        act as the competent authority for their supervision.
    - urn: urn:intuitem:risk:req_node:ai-act:node908
      assessable: false
      depth: 1
      name: CHAPTER VIII
      description: EU DATABASE FOR  HIGH-RISK AI SYSTEMS
    - urn: urn:intuitem:risk:req_node:ai-act:node909
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node908
      name: 'Article 71 '
      description: EU database for high-risk AI systems listed in Annex III
    - urn: urn:intuitem:risk:req_node:ai-act:71.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.1'
      description: The Commission shall, in collaboration with the Member States,
        set up and maintain an EU database containing information referred to in paragraphs
        2 and 3 of this Article concerning high-risk AI systems referred to in Article
        6(2) which are registered in accordance with Articles 49 and 60. When setting
        the functional specifications of such database, the Commission shall consult
        the relevant experts, and when updating the functional specifications of such
        database, the Commission shall consult the Board.
    - urn: urn:intuitem:risk:req_node:ai-act:71.2
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.2'
      description: The data listed in Section A of Annex VIII shall be entered into
        the EU database by the provider or, where applicable, by the authorised representative.
    - urn: urn:intuitem:risk:req_node:ai-act:71.3
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.3'
      description: The data listed in Section C of Annex VIII shall be entered into
        the EU database by the deployer who is, or who acts on behalf of, a public
        authority, agency or body, in accordance with Articles 49(2) and (3).
    - urn: urn:intuitem:risk:req_node:ai-act:71.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.4'
      description: With the exception of the section referred to in Article 49(4)
        and Article 60(5), the information contained in the EU database registered
        in accordance with Article 49 shall be accessible and publicly available in
        a user-friendly manner. The information should be easily navigable and machine-readable.
        The information registered in accordance with Article 60 shall be accessible
        only to market surveillance authorities and the Commission, unless the prospective
        provider or provider has given consent for also making the information accessible
        the public.
    - urn: urn:intuitem:risk:req_node:ai-act:71.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.5'
      description: The EU database shall contain personal data only in so far as necessary
        for collecting and processing information in accordance with this Regulation.
        That information shall include the names and contact details of natural persons
        who are responsible for registering the system and have the legal authority
        to represent the provider or the deployer, as applicable.
    - urn: urn:intuitem:risk:req_node:ai-act:71.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node909
      ref_id: '71.6'
      description: The Commission shall be the controller of the EU database. It shall
        make available to providers, prospective providers and deployers adequate
        technical and administrative support. The EU database shall comply with the
        applicable accessibility requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:node916
      assessable: false
      depth: 1
      name: CHAPTER IX
      description: POST-MARKET MONITORING, INFORMATION SHARING, MARKET SURVEILLANCE
    - urn: urn:intuitem:risk:req_node:ai-act:node917
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node916
      name: Section 1
      description: Post-market monitoring
    - urn: urn:intuitem:risk:req_node:ai-act:node918
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node917
      name: Article 72
      description: Post-market monitoring by providers and post-market monitoring
        plan for high-risk AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:72.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node918
      ref_id: '72.1'
      description: Providers shall establish and document a post-market monitoring
        system in a manner that is proportionate to the nature of the AI technologies
        and the risks of the high-risk AI system.
    - urn: urn:intuitem:risk:req_node:ai-act:72.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node918
      ref_id: '72.2'
      description: The post-market monitoring system shall actively and systematically
        collect, document and analyse relevant data which may be provided by deployers
        or which may be collected through other sources on the performance of high-risk
        AI systems throughout their lifetime, and which allow the provider to evaluate
        the continuous compliance of AI systems with the requirements set out in Chapter
        III, Section 2. Where relevant, post- market monitoring shall include an analysis
        of the interaction with other AI systems. This obligation shall not cover
        sensitive operational data of deployers which are law- enforcement authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:72.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node918
      ref_id: '72.3'
      description: The post-market monitoring system shall be based on a post-market
        monitoring plan. The post-market monitoring plan shall be part of the technical
        documentation referred to in Annex IV. The Commission shall adopt an implementing
        act laying down detailed provisions establishing a template for the post-market
        monitoring plan and the list of elements to be included in the plan by 2 February
        2026. That implementing act shall be adopted in accordance with the examination
        procedure referred to in Article 98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:72.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node918
      ref_id: '72.4'
      description: 'For high-risk AI systems covered by the Union harmonisation legislation
        listed in Section A of Annex I, where a post-market monitoring system and
        plan are already established under that legislation, in order to ensure consistency,
        avoid duplications and minimise additional burdens, providers shall have a
        choice of integrating, as appropriate, the necessary elements described in
        paragraphs 1, 2 and 3 using the template referred in paragraph 3 into systems
        and plans already existing under that legislation, provided that achieves
        an equivalent level of protection.

        The first subparagraph of this paragraph shall also apply to high-risk AI
        systems referred to in point 5 of Annex III placed on the market or put into
        service by financial institutions that are subject to requirements under Union
        financial services law regarding their internal governance, arrangements or
        processes.'
    - urn: urn:intuitem:risk:req_node:ai-act:node923
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node916
      name: Section 2
      description: Sharing of information on serious incidents
    - urn: urn:intuitem:risk:req_node:ai-act:node924
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node923
      name: Article 73
      description: Reporting of serious incidents
    - urn: urn:intuitem:risk:req_node:ai-act:73.1
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.1'
      description: Providers of high-risk AI systems placed on the Union market shall
        report any serious incident to the market surveillance authorities of the
        Member States where that incident occurred.
    - urn: urn:intuitem:risk:req_node:ai-act:73.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.2'
      description: 'The report referred to in paragraph 1 shall be made immediately
        after the provider has established a causal link between the AI system and
        the serious incident or  the reasonable likelihood of such a link, and, in
        any event, not later than 15 days after the provider or, where applicable,
        the deployer, becomes aware of the serious incident.

        The period for the reporting referred to in the first subparagraph shall take
        account of the severity of the serious incident  .'
    - urn: urn:intuitem:risk:req_node:ai-act:73.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.3'
      description: Notwithstanding paragraph 2 of this Article, in the event of a
        widespread infringement or a serious incident as defined in Article 3, point
        (44) (b), the report referred to in paragraph 1 of this Article shall be provided
        immediately, and not later than two days after the provider or, where applicable,
        the deployer becomes aware of that incident.
    - urn: urn:intuitem:risk:req_node:ai-act:73.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.5'
      description: Notwithstanding paragraph 2, in the event of the death of a person,
        the report shall be provided immediately after the provider or the deployer
        has established, or as soon as it suspects, a causal relationship between
        the high-risk AI system and the serious incident, but not later than 10 days
        after the date on which the provider or, where applicable, the deployer becomes
        aware of the serious incident.
    - urn: urn:intuitem:risk:req_node:ai-act:73.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.6'
      description: Where necessary to ensure timely reporting, the provider or, where
        applicable, the deployer, may submit an initial report that is incomplete,
        followed by a complete report.
    - urn: urn:intuitem:risk:req_node:ai-act:73.7
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.7'
      description: Following the reporting of a serious incident pursuant to paragraph
        1, the provider shall, without delay, perform the necessary investigations
        in relation to the serious incident and the AI system concerned. This shall
        include a risk assessment of the incident, and corrective action.
    - urn: urn:intuitem:risk:req_node:ai-act:node931
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      description: The provider shall cooperate with the competent authorities, and
        where relevant with the notified body concerned, during the investigations
        referred to in the first subparagraph, and shall not perform any investigation
        which involves altering the AI system concerned in a way which may affect
        any subsequent evaluation of the causes of the incident, prior to informing
        the competent authorities of such action.
    - urn: urn:intuitem:risk:req_node:ai-act:73.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.8'
      description: The market surveillance authority shall take appropriate measures,
        as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days
        from the date it received the notification referred to in paragraph 1 of this
        Article, and shall follow the notification procedures as provided in that
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:73.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.9'
      description: The market surveillance authority shall take appropriate measures,
        as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days
        from the date it received the notification referred to in paragraph 1 of this
        Article, and shall follow the notification procedures as provided in that
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:73.10
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.10'
      description: For high-risk AI systems referred to in  Annex III that are placed
        on the market or put into service by providers that are subject to Union legislative
        instruments laying down reporting obligations equivalent to those set out
        in this Regulation , the notification of serious incidents shall be limited
        to those referred to in Article 3, point (44)(c).
    - urn: urn:intuitem:risk:req_node:ai-act:73.11
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.11'
      description: For high-risk AI systems which are safety components of devices,
        or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746,
        the notification of serious incidents shall be limited to those referred to
        in Article 3, point (44)(c) of this Regulation, and shall be made to the national
        competent authority chosen for that purpose by the Member States where the
        incident occurred.
    - urn: urn:intuitem:risk:req_node:ai-act:73.12
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node924
      ref_id: '73.12'
      description: National competent authorities shall immediately notify the Commission
        of any serious incident, whether or not it they have taken action on it, in
        accordance with Article 20 of Regulation (EU) 2019/1020.
    - urn: urn:intuitem:risk:req_node:ai-act:node937
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node916
      name: Section 3
      description: Enforcement
    - urn: urn:intuitem:risk:req_node:ai-act:node938
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 74
      description: Market surveillance and control of AI systems in the Union market
    - urn: urn:intuitem:risk:req_node:ai-act:74.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.1'
      description: 'Regulation (EU) 2019/1020 shall apply to AI systems covered by
        this Regulation. For the purposes of the effective enforcement of this Regulation:

        (a) any reference to an economic operator under Regulation (EU) 2019/1020
        shall be understood as including all operators identified in Article 2(1)
        of this Regulation;

        (b) any reference to a product under Regulation (EU) 2019/1020 shall be understood
        as including all AI systems falling within the scope of this Regulation.'
    - urn: urn:intuitem:risk:req_node:ai-act:74.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.2'
      description: As part of their reporting obligations under Article 34(4) of Regulation
        (EU) 2019/1020, the market surveillance authorities shall report annually
        to the Commission and relevant national competition authorities any information
        identified in the course of market surveillance activities that may be of
        potential interest for the application of Union law on competition rules.
        They shall also annually report to the Commission about the use of prohibited
        practices that occurred during that year and about the measures taken.
    - urn: urn:intuitem:risk:req_node:ai-act:74.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.3'
      description: For high-risk AI systems related to products covered by the Union
        harmonisation legislation listed in Section A of Annex I, the market surveillance
        authority for the purposes of this Regulation shall be the authority responsible
        for market surveillance activities designated under those legal acts. By derogation
        from the paragraph 2, and in appropriate circumstances, Member States may
        designate another relevant authority to act as a market surveillance authority,
        provided they ensure coordination with the relevant sectoral market surveillance
        authorities responsible for the enforcement of the legal acts listed in Annex
        I.
    - urn: urn:intuitem:risk:req_node:ai-act:74.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.4'
      description: The procedures referred to in Articles 79 to 83 of this Regulation
        shall not apply to AI systems related to products covered by the Union harmonisation
        legislation listed in section A of Annex I, where such legal acts already
        provide for procedures ensuring an equivalent level of protection and having
        the same objective. In such cases, the relevant sectoral procedures shall
        apply instead.
    - urn: urn:intuitem:risk:req_node:ai-act:74.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.5'
      description: Without prejudice to the powers of market surveillance authorities
        under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring
        the effective enforcement of this Regulation, market surveillance authorities
        may exercise the powers referred to in Article 14(4), points (d) and (j),
        of that Regulation remotely, as appropriate.
    - urn: urn:intuitem:risk:req_node:ai-act:74.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.6'
      description: For high-risk AI systems placed on the market, put into service,
        or used by financial institutions regulated by Union financial services law,
        the market surveillance authority for the purposes of this Regulation shall
        be the relevant national authority responsible for the financial supervision
        of those institutions under that legislation in so far as the placing on the
        market, putting into service, or the use of the AI system is in direct connection
        with the provision of those financial services.
    - urn: urn:intuitem:risk:req_node:ai-act:74.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.7'
      description: 'By way of derogation from paragraph 6, in appropriate circumstances,
        and provided that coordination is ensured, another relevant authority may
        be identified by the Member State as market surveillance authority for the
        purposes of this Regulation.

        National market surveillance authorities supervising regulated credit institutions
        regulated under Directive 2013/36/EU, which are participating in the Single
        Supervisory Mechanism established by Regulation No 1024/2013, should report,
        without delay, to the European Central Bank any information identified in
        the course of their market surveillance activities that may be of potential
        interest for the prudential supervisory tasks of the European Central Bank
        specified in that Regulation.'
    - urn: urn:intuitem:risk:req_node:ai-act:74.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.8'
      description: For high-risk AI systems listed in point 1 of Annex III, in so
        far as the systems are used for law enforcement purposes, border management
        and justice and democracy, and for high- risk AI systems listed in points
        6, 7 and 8 of Annex III to this Regulation, Member States shall designate
        as market surveillance authorities for the purposes of this Regulation either
        the competent data protection supervisory authorities under Regulation (EU)
        2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant
        to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680.
        Market surveillance activities shall in no way affect the independence of
        judicial authorities, or otherwise interfere with their activities when acting
        in their judicial capacity.
    - urn: urn:intuitem:risk:req_node:ai-act:74.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.9'
      description: Where Union institutions, bodies, offices or agencies fall within
        the scope of this Regulation, the European Data Protection Supervisor shall
        act as their market surveillance authority, except in relation to the Court
        of Justice of the European Union acting in its judicial capacity.
    - urn: urn:intuitem:risk:req_node:ai-act:74.10
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.10'
      description: Member States shall facilitate coordination between market surveillance
        authorities designated under this Regulation and other relevant national authorities
        or bodies which supervise the application of Union harmonisation legislation
        listed in Annex I, or in other Union law, that might be relevant for the high-risk
        AI systems referred to in Annex III.
    - urn: urn:intuitem:risk:req_node:ai-act:74.11
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.11'
      description: Market surveillance authorities and the Commission shall be able
        to propose joint activities, including joint investigations, to be conducted
        by either market surveillance authorities or market surveillance authorities
        jointly with the Commission, that have the aim of promoting compliance, identifying
        non-compliance, raising awareness or providing guidance in relation to this
        Regulation with respect to specific categories of high-risk AI systems that
        are found to present a serious risk across two or more Member States in accordance
        with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination
        support for joint investigations.
    - urn: urn:intuitem:risk:req_node:ai-act:74.12
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.12'
      description: "Without prejudice to the powers provided for under Regulation\
        \ (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil\
        \ their tasks, the market surveillance authorities shall be granted full access\
        \ by providers to the documentation as well as the training, validation and\
        \ testing data sets used for the development of high- risk AI systems, including,\
        \ where appropriate and subject to security safeguards, through application\
        \ programming interfaces (\u2018API\u2019) or other relevant technical means\
        \ and tools enabling remote access."
    - urn: urn:intuitem:risk:req_node:ai-act:74.13
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.13'
      description: 'Market surveillance authorities shall be granted access to the
        source code of the high- risk AI system upon a reasoned request and only when
        both of the following conditions are fulfilled:

        (a) access to source code is necessary to assess the conformity of a high-risk
        AI system with the requirements set out in Chapter III, Section 2; and,

        (b) testing or auditing procedures and verifications based on the data and
        documentation provided by the provider have been exhausted or proved insufficient.'
    - urn: urn:intuitem:risk:req_node:ai-act:74.14
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node938
      ref_id: '74.14'
      description: Any information or documentation obtained by market surveillance
        authorities shall be treated in compliance with the confidentiality obligations
        set out in Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node953
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 75
      description: Mutual assistance, market surveillance and control of general-purpose
        AI systems
    - urn: urn:intuitem:risk:req_node:ai-act:75.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node953
      ref_id: '75.1'
      description: Where an AI system is based on a general-purpose AI model, and
        the model and the system are developed by the same provider, the AI Office
        shall have powers to monitor and supervise compliance of that AI system with
        obligations under this Regulation. To carry out its monitoring and supervision
        tasks, the AI Office shall have all the powers of a market surveillance authority
        within the meaning of Regulation (EU) 2019/1020.
    - urn: urn:intuitem:risk:req_node:ai-act:75.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node953
      ref_id: '75.2'
      description: Where the relevant market surveillance authorities have sufficient
        reason to consider general-purpose AI systems that can be used directly by
        deployers for at least one purpose that is classified as high-risk pursuant
        to this Regulation to be non-compliant with the requirements laid down in
        this Regulation, they shall cooperate with the AI Office to carry out compliance
        evaluations, and shall inform the Board and other market surveillance authorities
        accordingly.
    - urn: urn:intuitem:risk:req_node:ai-act:75.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node953
      ref_id: '75.3'
      description: Where a national market surveillance authority is unable to conclude
        its investigation of the high-risk AI system because of its inability to access
        certain information related to the AI model despite having made all appropriate
        efforts to obtain that information, it may submit a reasoned request to the
        AI Office, by which access to that information shall be enforced. In that
        case, the AI Office shall supply to the applicant authority without delay,
        and in any event within 30 days, any information that the AI Office considers
        to be relevant in order to establish whether a high-risk AI system is non-
        compliant. National market authorities shall safeguard the confidentiality
        of the information they obtain in accordance with Article 78 of this Regulation.
        The procedure provided for in Chapter VI of Regulation (EU) 2019/1020 shall
        apply mutatis mutandis.
    - urn: urn:intuitem:risk:req_node:ai-act:node957
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 76
      description: Supervision of testing in real world conditions by market surveillance
        authorities
    - urn: urn:intuitem:risk:req_node:ai-act:76.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node957
      ref_id: '76.1'
      description: Market surveillance authorities shall have competences and powers
        to ensure that testing in real world conditions is in accordance with this
        Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:76.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node957
      ref_id: '76.2'
      description: Where testing in real world conditions is conducted for AI systems
        that are supervised within an AI regulatory sandbox under Article 59, the
        market surveillance authorities shall verify the compliance with the provisions
        of Article 60 as part of their supervisory role for the AI regulatory sandbox.
        Those authorities may, as appropriate, allow the testing in real world conditions
        to be conducted by the provider or prospective provider, in derogation from
        the conditions set out in Article 60(4), points (f) and (g).
    - urn: urn:intuitem:risk:req_node:ai-act:76.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node957
      ref_id: '76.3'
      description: 'Where a market surveillance authority has been informed by the
        prospective provider, the provider or any third party of a serious incident
        or has other grounds for considering that the conditions set out in Articles
        60 and 61 are not met, it may take either of the following decisions on its
        territory, as appropriate:

        (a) to suspend or terminate the testing in real world conditions;

        (b) to require the provider or prospective provider and users to modify any
        aspect of the testing in real world conditions.'
    - urn: urn:intuitem:risk:req_node:ai-act:76.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node957
      ref_id: '76.4'
      description: Where a market surveillance authority has taken a decision referred
        to in paragraph 3 of this Article, or has issued an objection within the meaning
        of Article 60(4), point (b), the decision or the objection shall indicate
        the grounds therefor and how the provider or prospective provider can challenge
        the decision or objection.
    - urn: urn:intuitem:risk:req_node:ai-act:76.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node957
      ref_id: '76.5'
      description: Where applicable, where a market surveillance authority has taken
        a decision referred to in paragraph 3, it shall communicate the grounds therefor
        to the market surveillance authorities of other Member States in which the
        AI system has been tested in accordance with the testing plan.
    - urn: urn:intuitem:risk:req_node:ai-act:node963
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 77
      description: Powers of authorities protecting fundamental rights
    - urn: urn:intuitem:risk:req_node:ai-act:77.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node963
      ref_id: '77.1'
      description: National public authorities or bodies which supervise or enforce
        the respect of obligations under Union law protecting fundamental rights,
        including the right to non-discrimination, in relation to the use of high-risk
        AI systems referred to in Annex III shall have the power to request and access
        any documentation created or maintained under this Regulation in accessible
        language and format when access to that documentation is necessary for effectively
        fulfilling their mandates within the limits of their jurisdiction. The relevant
        public authority or body shall inform the market surveillance authority of
        the Member State concerned of any such request.
    - urn: urn:intuitem:risk:req_node:ai-act:77.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node963
      ref_id: '77.2'
      description: By 2 November 2024, each Member State shall identify the public
        authorities or bodies referred to in paragraph 1 and make a list of them publicly
        available. Member States shall notify the list to the Commission and to the
        other Member States, and shall keep the list up to date.
    - urn: urn:intuitem:risk:req_node:ai-act:77.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node963
      ref_id: '77.3'
      description: Where the documentation referred to in paragraph 1 is insufficient
        to ascertain whether an infringement of obligations under Union law protecting
        fundamental rights has occurred, the public authority or body referred to
        in paragraph 1 may make a reasoned request to the market surveillance authority,
        to organise testing of the high-risk AI system through technical means. The
        market surveillance authority shall organise the testing with the close involvement
        of the requesting public authority or body within a reasonable time following
        the request.
    - urn: urn:intuitem:risk:req_node:ai-act:77.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node963
      ref_id: '77.4'
      description: Any information or documentation obtained by the national public
        authorities or bodies referred to in paragraph 1 of this Article pursuant
        to this Article shall be treated in compliance with the confidentiality obligations
        set out in Article 78.
    - urn: urn:intuitem:risk:req_node:ai-act:node968
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 78
      description: Confidentiality
    - urn: urn:intuitem:risk:req_node:ai-act:78.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      ref_id: '78.1'
      description: "The Commission, market surveillance authorities and notified bodies\
        \ and any other natural or legal person involved in the application of this\
        \ Regulation shall, in accordance with Union and national law, respect the\
        \ confidentiality of information and data obtained in carrying out their tasks\
        \ and activities in such a manner as to protect, in particular:\n(a) the intellectual\
        \ property rights and confidential business information or trade secrets of\
        \ a natural or legal person, including source code, except in the cases referred\
        \ to in Article 5 of Directive (EU) 2016/943 of the European Parliament and\
        \ of the Council60 on the protection of undisclosed know-how and business\
        \ information (trade secrets) against their unlawful acquisition, use and\
        \ disclosure;\n(b) the effective implementation of this Regulation, in particular\
        \ for the purposes of inspections, investigations or audits; \n(c) public\
        \ and national security interests;\n(d) the conduct of criminal or administrative\
        \ proceedings;\n(e) information classified pursuant to Union or national law."
    - urn: urn:intuitem:risk:req_node:ai-act:78.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      ref_id: '78.2'
      description: The authorities involved in the application of this Regulation
        pursuant to paragraph 1 shall request only data that is strictly necessary
        for the assessment of the risk posed by AI systems and for the exercise of
        their powers in compliance with this Regulation and Regulation (EU) 2019/1020.
        They shall put in place adequate and effective cybersecurity measures to protect
        the security and confidentiality of the information and data obtained, and
        shall delete the data collected as soon as it is no longer needed for the
        purpose for which it was obtained, in accordance with applicable Union or
        national law.
    - urn: urn:intuitem:risk:req_node:ai-act:78.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      ref_id: '78.3'
      description: Without prejudice to paragraphs 1 and 2, information exchanged
        on a confidential basis between the national competent authorities or between
        national competent authorities and the Commission shall not be disclosed without
        prior consultation of the originating national competent authority and the
        deployer when high-risk AI systems referred to in point 1, 6 or 7 of Annex
        III are used by law enforcement, border control, immigration or asylum authorities
        and when such disclosure would jeopardise public and national security interests.
        This exchange of information shall not cover sensitive operational data in
        relation to the activities of law enforcement, border control, immigration
        or asylum authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:node972
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      description: When the law enforcement, immigration or asylum authorities are
        providers of high-risk AI systems referred to in point 1, 6 or 7 of Annex
        III, the technical documentation referred to in Annex IV shall remain within
        the premises of those authorities. Those authorities shall ensure that the
        market surveillance authorities referred to in Article 74(8) and (9), as applicable,
        can, upon request, immediately access the documentation or obtain a copy thereof.
        Only staff of the market surveillance authority holding the appropriate level
        of security clearance shall be allowed to access that documentation or any
        copy thereof.
    - urn: urn:intuitem:risk:req_node:ai-act:78.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      ref_id: '78.4'
      description: Paragraphs 1, 2 and 3 shall not affect the rights or obligations
        of the Commission, Member States and their relevant authorities, as well as
        those of notified bodies, with regard to the exchange of information and the
        dissemination of warnings, including in the context of cross-border cooperation,
        nor shall they affect the obligations of the parties concerned to provide
        information under criminal law of the Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:78.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node968
      ref_id: '78.5'
      description: The Commission and Member States may exchange, where necessary
        and in accordance with relevant provisions of international and trade agreements,
        confidential information with regulatory authorities of third countries with
        which they have concluded bilateral or multilateral confidentiality arrangements
        guaranteeing an adequate level of confidentiality.
    - urn: urn:intuitem:risk:req_node:ai-act:node975
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 79
      description: Procedure at national level for dealing with AI systems presenting
        a risk
    - urn: urn:intuitem:risk:req_node:ai-act:79.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.1'
      description: "AI systems presenting a risk shall be understood as a \u201Cproduct\
        \ presenting a risk\u201D as defined in Article 3, point 19 of Regulation\
        \ (EU) 2019/1020, in so far as they present risks to the health or safety,\
        \ or to  fundamental rights, of persons."
    - urn: urn:intuitem:risk:req_node:ai-act:79.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.2'
      description: 'Where the market surveillance authority of a Member State has
        sufficient reason to consider an AI system to present a risk as referred to
        in paragraph 1 of this Article, it shall carry out an evaluation of the AI
        system concerned in respect of its compliance with all the requirements and
        obligations laid down in this Regulation. Particular attention shall be given
        to AI systems presenting a risk to groups of vulnerable persons referred to
        in Article 5. Where risks to fundamental rights of persons are identified,
        the market surveillance authority shall also inform and fully cooperate with
        the relevant national public authorities or bodies referred to in Article
        77(1). The relevant operators shall cooperate as necessary with the market
        surveillance authority and with the other national public authorities or bodies
        referred to in Article 77(1).

        Where, in the course of that evaluation, the market surveillance authority
        or, where applicable the market surveillance authority in cooperation with
        the national public authority referred to in Article 77(1), finds that the
        AI system does not comply with the requirements and obligations laid down
        in this Regulation, it shall without undue delay require the relevant operator
        to take all appropriate corrective actions to bring the AI system into compliance,
        to withdraw the AI system from the market, or to recall it within a period
        the market surveillance authority may prescribe, and in any event within the
        shorter of 15 working days, or as provided for in the relevant Union harmonisation
        legislation.

        The market surveillance authority shall inform the relevant notified body
        accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures
        referred to in the second subparagraph of this paragraph.'
    - urn: urn:intuitem:risk:req_node:ai-act:79.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.3'
      description: Where the market surveillance authority considers that the non-compliance
        is not restricted to its national territory, it shall inform the Commission
        and the other Member States without undue delay of the results of the evaluation
        and of the actions which it has required the operator to take.
    - urn: urn:intuitem:risk:req_node:ai-act:79.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.4'
      description: The operator shall ensure that all appropriate corrective action
        is taken in respect of all the AI systems concerned that it has made available
        on the Union market.
    - urn: urn:intuitem:risk:req_node:ai-act:79.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.5'
      description: Where the operator of an AI system does not take adequate corrective
        action within the period referred to in paragraph 2, the market surveillance
        authority shall take all appropriate provisional measures to prohibit or restrict
        the AI system's being made available on its national market or put into service,
        to withdraw the product or the standalone AI system from that market or to
        recall it. That authority shall without undue delay notify the Commission
        and the other Member States  of those measures.
    - urn: urn:intuitem:risk:req_node:ai-act:79.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.6'
      description: 'The notification referred to in paragraph 5 shall include all
        available details, in particular the information necessary for the identification
        of the non-compliant AI system, the origin of the AI system and the supply
        chain, the nature of the non-compliance alleged and the risk involved, the
        nature and duration of the national measures taken and the arguments put forward
        by the relevant operator. In particular, the market surveillance authorities
        shall indicate whether the non-compliance is due to one or more of the following:

        (a) non-compliance with the prohibition of the AI practices referred to in
        Article 5;

        (b) a failure of a high-risk AI system to meet requirements set out in Chapter
        III,

        Section 2;

        (c) shortcomings in the harmonised standards or common specifications referred
        to in Articles 40 and 41 conferring a presumption of conformity;

        (d) non-compliance with Article 50.'
    - urn: urn:intuitem:risk:req_node:ai-act:79.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.7'
      description: The market surveillance authorities of the Member States other
        than the market surveillance authority of the Member State initiating the
        procedure shall, without undue delay, inform the Commission and the other
        Member States of any measures adopted and of any additional information at
        their disposal relating to the non-compliance of the AI system concerned,
        and, in the event of disagreement with the notified national measure, of their
        objections.
    - urn: urn:intuitem:risk:req_node:ai-act:79.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.8'
      description: Where, within three months of receipt of the notification referred
        to in paragraph 5 of this Article, no objection has been raised by either
        a market surveillance authority of a Member State or by the Commission in
        respect of a provisional measure taken by a market surveillance authority
        of another Member State, that measure shall be deemed justified. This shall
        be without prejudice to the procedural rights of the concerned operator in
        accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period
        referred to in this paragraph shall be reduced to 30 days in the event of
        non-compliance with the prohibition of the AI practices referred to in Article
        5 of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:79.9
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node975
      ref_id: '79.9'
      description: The market surveillance authorities of the Member States shall
        ensure that appropriate restrictive measures are taken in respect of the product
        or the AI system concerned, such as withdrawal of the product or the AI system
        from their market, without undue delay.
    - urn: urn:intuitem:risk:req_node:ai-act:node985
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 80
      description: Procedure for dealing with AI systems classified by the provider
        as non-high-risk in application of Annex III
    - urn: urn:intuitem:risk:req_node:ai-act:80.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.1'
      description: Where a market surveillance authority has sufficient reason to
        consider that an AI system classified by the provider is not high-risk pursuant
        to Article 6(3)I is indeed high- risk, the market surveillance authority shall
        carry out an evaluation of the AI system concerned in respect of its classification
        as a high-risk AI system based on the conditions set out in Article 6(3) and
        the Commission guidelines.
    - urn: urn:intuitem:risk:req_node:ai-act:80.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.2'
      description: Where, in the course of that evaluation, the market surveillance
        authority finds that the AI system concerned is high-risk, it shall without
        undue delay require the relevant provider to take all necessary actions to
        bring the AI system into compliance with the requirements and obligations
        laid down in this Regulation, as well as take appropriate corrective action
        within a period the market surveillance authority may prescribe.
    - urn: urn:intuitem:risk:req_node:ai-act:80.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.3'
      description: Where the market surveillance authority considers that the use
        of the AI system concerned is not restricted to its national territory, it
        shall inform the Commission and the other Member States without undue delay
        of the results of the evaluation and of the actions which it has required
        the provider to take.
    - urn: urn:intuitem:risk:req_node:ai-act:80.4
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.4'
      description: The provider shall ensure that all necessary action is taken to
        bring the AI system into compliance with the requirements and obligations
        laid down in this Regulation. Where the provider of an AI system concerned
        does not bring the AI system into compliance with those requirements and obligations
        within the period referred to in paragraph 2 of this Article, the provider
        shall be subject to fines in accordance with Article 99.
    - urn: urn:intuitem:risk:req_node:ai-act:80.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.5'
      description: The provider shall ensure that all appropriate corrective action
        is taken in respect of all the AI systems concerned that it has made available
        on the Union market.
    - urn: urn:intuitem:risk:req_node:ai-act:80.6
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.6'
      description: The provider shall ensure that all appropriate corrective action
        is taken in respect of all the AI systems concerned that it has made available
        on the Union market.
    - urn: urn:intuitem:risk:req_node:ai-act:80.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.7'
      description: Where, in the course of the evaluation pursuant to paragraph 1
        of this Article, the market surveillance authority establishes that the AI
        system was misclassified by the provider as not high-risk in order to circumvent
        the application of requirements in Chapter III, Section 2, the provider shall
        be subject to fines in accordance with Article 99.
    - urn: urn:intuitem:risk:req_node:ai-act:80.8
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node985
      ref_id: '80.8'
      description: In exercising their power to monitor the application of this Article,
        and in accordance with Article 11 of Regulation (EU) 2019/1020, market surveillance
        authorities may perform appropriate checks, taking into account in particular
        information stored in the EU database referred to in Article 71 of this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node994
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 81
      description: Union safeguard procedure
    - urn: urn:intuitem:risk:req_node:ai-act:81.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node994
      ref_id: '81.1'
      description: Where, within three months of receipt of the notification referred
        to in Article 79(5), or within 30 days in the case of non-compliance with
        the prohibition of the AI practices referred to in Article 5, objections are
        raised by the market surveillance authority of a Member State to a measure
        taken by another market surveillance authority, or where the Commission considers
        the measure to be contrary to Union law, the Commission shall without undue
        delay enter into consultation with the market surveillance authority of the
        relevant Member State and the operator or operators, and shall evaluate the
        national measure. On the basis of the results of that evaluation, the Commission
        shall, within six months, or within 60 days in the case of non-compliance
        with the prohibition of the AI practices referred to in Article 5, starting
        from the notification referred to in Article 79(5), decide whether the national
        measure is justified and shall notify its decision to the market surveillance
        authority of the Member State concerned. The Commission shall also inform
        all other market surveillance authorities of its decision.
    - urn: urn:intuitem:risk:req_node:ai-act:81.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node994
      ref_id: '81.2'
      description: Where the Commission considers the measure taken by the relevant
        Member State to be justified, all Member States shall ensure that they take
        appropriate restrictive measures in respect of the AI system concerned, such
        as requiring the withdrawal of the AI system from their market without undue
        delay, and shall inform the Commission accordingly. Where the Commission considers
        the national measure to be unjustified, the Member State concerned shall withdraw
        the measure and shall inform the Commission accordingly.
    - urn: urn:intuitem:risk:req_node:ai-act:81.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node994
      ref_id: '81.3'
      description: Where the national measure is considered justified and the non-compliance
        of the AI system is attributed to shortcomings in the harmonised standards
        or common specifications referred to in Articles 40 and 41 of this Regulation,
        the Commission shall apply the procedure provided for in Article 11 of Regulation
        (EU) No 1025/2012.
    - urn: urn:intuitem:risk:req_node:ai-act:node998
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 82
      description: Compliant AI systems which present a risk
    - urn: urn:intuitem:risk:req_node:ai-act:82.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node998
      ref_id: '82.1'
      description: Where, having performed an evaluation under Article 79, after consulting
        the relevant national public authority referred to in Article 77(1), the market
        surveillance authority of a Member State finds that although a high-risk AI
        system is in compliance with this Regulation, it nevertheless presents a risk
        to the health or safety of persons,  to fundamental rights of persons, or
        to other aspects of public interest protection, it shall require the relevant
        operator to take all appropriate measures to ensure that the AI system concerned,
        when placed on the market or put into service, no longer presents that risk
        without undue delay, within a  period  it may prescribe.
    - urn: urn:intuitem:risk:req_node:ai-act:82.2
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node998
      ref_id: '82.2'
      description: The provider or other relevant operator shall ensure that corrective
        action is taken in respect of all the AI systems concerned that it has made
        available on the Union market within the timeline prescribed by the market
        surveillance authority of the Member State referred to in paragraph 1.
    - urn: urn:intuitem:risk:req_node:ai-act:82.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node998
      ref_id: '82.3'
      description: The Member States shall immediately inform the Commission and the
        other Member States of a finding under paragraph 1. That information shall
        include all available details, in particular the data necessary for the identification
        of the AI system concerned, the origin and the supply chain of the AI system,
        the nature of the risk involved and the nature and duration of the national
        measures taken.
    - urn: urn:intuitem:risk:req_node:ai-act:82.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node998
      ref_id: '82.4'
      description: The Commission shall without undue delay enter into consultation
        with the Member State or member States concerned and the relevant operators,
        and shall evaluate the national measures taken. On the basis of the results
        of that evaluation, the Commission shall decide whether the measure is justified
        and, where necessary, propose other appropriate measures.
    - urn: urn:intuitem:risk:req_node:ai-act:82.5
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node998
      ref_id: '82.5'
      description: The Commission shall immediately communicate its decision to the
        Member States concerned and to the relevant operators. It shall also inform
        the other Member States.
    - urn: urn:intuitem:risk:req_node:ai-act:node1004
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 83
      description: Formal non-compliance
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1004
      ref_id: 83.1.a
      description: 'Where the market surveillance authority of a Member State makes
        one of the following findings, it shall require the relevant provider to put
        an end to the non-compliance concerned, within a period it may prescribe:

        a CE marking has been affixed in violation of Article 48;'
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.b
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.b
      description: a CE marking has not been affixed;
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.c
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.c
      description: a EU declaration of conformity has not been drawn up;
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.d
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.d
      description: a EU declaration of conformity has not been drawn up correctly;
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.e
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.e
      description: registration in the EU database has not been carried out;
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.f
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.f
      description: where applicable, an authorised representative has not been appointed;
    - urn: urn:intuitem:risk:req_node:ai-act:83.1.g
      assessable: true
      depth: 5
      parent_urn: urn:intuitem:risk:req_node:ai-act:83.1.a
      ref_id: 83.1.g
      description: technical documentation is not available.
    - urn: urn:intuitem:risk:req_node:ai-act:83.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1004
      ref_id: '83.2'
      description: Where the non-compliance referred to in paragraph 1 persists, the
        market surveillance authority of the Member State concerned shall take appropriate
        and proportionate measures to restrict or prohibit the high-risk AI system
        being made available on the market or to ensure that it is recalled or withdrawn
        from the market without delay.
    - urn: urn:intuitem:risk:req_node:ai-act:node1013
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node937
      name: Article 84
      description: Union AI testing support structures
    - urn: urn:intuitem:risk:req_node:ai-act:84.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1013
      ref_id: '84.1'
      description: The Commission shall designate one or more Union AI testing support
        structures to perform the tasks listed under Article 21(6) of Regulation (EU)
        2019/1020 in the area of AI.
    - urn: urn:intuitem:risk:req_node:ai-act:84.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1013
      ref_id: '84.2'
      description: Without prejudice to the tasks referred to in paragraph 1, Union
        AI testing support structures shall also provide independent technical or
        scientific advice at the request of the Board, the Commission, or of market
        surveillance authorities.
    - urn: urn:intuitem:risk:req_node:ai-act:node1016
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node916
      name: Section 4
      description: Remedies
    - urn: urn:intuitem:risk:req_node:ai-act:node1017
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1016
      name: Article 85
      description: Right to lodge a complaint with a market surveillance authority
    - urn: urn:intuitem:risk:req_node:ai-act:node1018
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1017
      description: 'Without prejudice to other administrative or judicial remedies,
        any natural or legal person having grounds to consider that there has been
        an infringement of the provisions of this Regulation may submit reasoned complaints
        to the relevant market surveillance authority.

        In accordance with Regulation (EU) 2019/1020, such complaints shall be taken
        into account for the purpose of conducting market surveillance activities,
        and shall be handled in line with the dedicated procedures established therefor
        by the market surveillance authorities.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1019
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1016
      name: Article 86
      description: Right to explanation of individual decision-making
    - urn: urn:intuitem:risk:req_node:ai-act:node1020
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1019
      description: Any affected person subject to a decision which is taken by the
        deployer on the basis of the output from a high-risk AI system listed in Annex
        III, with the exception of systems listed under point 2 thereof, and which
        produces legal effects or similarly significantly affects that person in a
        way that they consider to have an adverse impact on their health, safety or
        fundamental rights shall have the right to obtain from the deployer clear
        and meaningful explanations of the role of the AI system in the decision-making
        procedure and the main elements of the decision taken.
    - urn: urn:intuitem:risk:req_node:ai-act:node1021
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1019
      description: Paragraph 1 shall not apply to the use of AI systems for which
        exceptions from, or restrictions to, the obligation under paragraph 1 follow
        from Union or national law in compliance with Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:node1022
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1019
      description: This Article shall apply only to the extent that the right referred
        to in paragraph 1 is not otherwise provided for under Union law.
    - urn: urn:intuitem:risk:req_node:ai-act:node1023
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1016
      name: Article 87
      description: Reporting of infringements and protection of reporting persons
    - urn: urn:intuitem:risk:req_node:ai-act:node1024
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1023
      description: Directive (EU) 2019/1937 shall apply to the reporting of infringements
        of this Regulation and the protection of persons reporting such infringements.
    - urn: urn:intuitem:risk:req_node:ai-act:node1025
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node916
      name: Section 5
      description: Supervision, investigation, enforcement and monitoring in respect
        of providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:node1026
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 88
      description: Enforcement of the obligations of providers of general-purpose
        AI models
    - urn: urn:intuitem:risk:req_node:ai-act:88.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1026
      ref_id: '88.1'
      description: The Commission shall have exclusive powers to supervise and enforce
        Chapter V, taking into account the procedural guarantees under Article 94.
        The Commission shall entrust the implementation of these tasks to the AI Office,
        without prejudice to the powers of organisation of the Commission and the
        division of competences between Member States and the Union based on the Treaties.
    - urn: urn:intuitem:risk:req_node:ai-act:88.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1026
      ref_id: '88.2'
      description: Without prejudice to Article 75(3), market surveillance authorities
        may request the Commission to exercise the powers laid down in this Section,
        where that is necessary and proportionate to assist with the fulfilment of
        their tasks under this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node1029
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 89
      description: Monitoring actions
    - urn: urn:intuitem:risk:req_node:ai-act:89.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1029
      ref_id: '89.1'
      description: For the purpose of carrying out the tasks assigned to it under
        this Section, the AI Office may take the necessary actions to monitor the
        effective implementation and compliance with this Regulation by providers
        of general-purpose AI models, including their adherence to approved codes
        of practice.
    - urn: urn:intuitem:risk:req_node:ai-act:89.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1029
      ref_id: '89.2'
      description: 'Downstream providers shall have the right to lodge a complaint
        alleging an infringement of this Regulation. A complaint shall be duly reasoned
        and indicate at least:

        (a) the point of contact of the provider of the general-purpose AI model concerned;

        (b) a description of the relevant facts, the provisions of this Regulation
        concerned, and the reason why the downstream provider considers that the provider
        of the general- purpose AI model concerned infringed this Regulation;

        (c) any other information that the downstream provider that sent the request
        considers relevant, including, where appropriate, information gathered on
        its own initiative.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1032
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 90
      description: Alerts of systemic risks by the scientific panel
    - urn: urn:intuitem:risk:req_node:ai-act:90.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1032
      ref_id: '90.1'
      description: 'The scientific panel may provide a qualified alert to the AI Office
        where it has reason to suspect that:

        (a) a general-purpose AI model poses concrete identifiable risk at Union level;
        or,

        (b) a general-purpose AI model meets the requirements referred to in Article
        51 .'
    - urn: urn:intuitem:risk:req_node:ai-act:90.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1032
      ref_id: '90.2'
      description: Upon such qualified alert, the Commission, through the AI Office
        and after having informed the Board, may exercise the powers laid down in
        this Chapter for the purpose of assessing the matter. The AI Office shall
        inform the Board of any measure according to Articles 91 to 94.
    - urn: urn:intuitem:risk:req_node:ai-act:90.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1032
      ref_id: '90.3'
      description: 'A qualified alert shall be duly reasoned and indicate at least:

        (a) the point of contact of the provider of the general-purpose AI model with
        systemic risk concerned;

        (b) a description of the relevant facts and the reasons for the alert by the
        scientific panel;

        (c) any other information that the scientific panel considers to be relevant,
        including, where appropriate, information gathered on its own initiative.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1036
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 91
      description: Power to request documentation and information
    - urn: urn:intuitem:risk:req_node:ai-act:91.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1036
      ref_id: '91.1'
      description: The Commission may request the provider of the general-purpose
        AI model concerned to provide the documentation drawn up by the provider according
        to Articles 53 and 55, or any additional information that is necessary for
        the purpose of assessing compliance of the provider with this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:91.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1036
      ref_id: '91.2'
      description: Before sending the request for information, the AI Office may initiate
        a structured dialogue with the provider of the general-purpose AI model.
    - urn: urn:intuitem:risk:req_node:ai-act:91.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1036
      ref_id: '91.3'
      description: Upon a duly substantiated request from the scientific panel, the
        Commission may issue a request for information to a provider of a general-purpose
        AI model, where the access to information is necessary and proportionate for
        the fulfilment of the tasks of the scientific panel under Article 68(2).
    - urn: urn:intuitem:risk:req_node:ai-act:91.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1036
      ref_id: '91.4'
      description: The request for information shall state the legal basis and the
        purpose of the request, specify what information is required, and set a period
        within which the information is to be provided, and indicate the fines provided
        for in Article 101 for supplying incorrect, incomplete or misleading information.
    - urn: urn:intuitem:risk:req_node:ai-act:91.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1036
      ref_id: '91.5'
      description: The provider of the general-purpose AI model concerned, or its
        representative shall supply the information requested. In the case of legal
        persons, companies or firms, or where the provider has no legal personality,
        the persons authorised to represent them by law or by their statutes, shall
        supply the information requested on behalf of the provider of the general-purpose
        AI model concerned. Lawyers duly authorised to act may supply information
        on behalf of their clients. The clients shall nevertheless remain fully responsible
        if the information supplied is incomplete, incorrect or misleading.
    - urn: urn:intuitem:risk:req_node:ai-act:node1042
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 92
      description: 'Power to conduct evaluations '
    - urn: urn:intuitem:risk:req_node:ai-act:92.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.1'
      description: 'The AI Office, after consulting the Board, may conduct evaluations
        of the general- purpose AI model concerned:

        (a) to assess compliance of the provider with obligations under this Regulation,
        where the information gathered pursuant to Article 91 is insufficient; or,

        (b) to investigate systemic risks at Union level of general-purpose AI models
        with systemic risk, in particular following a qualified report from the scientific
        panel in accordance with Article 89(1), point (a).'
    - urn: urn:intuitem:risk:req_node:ai-act:92.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.2'
      description: The Commission may decide to appoint independent experts to carry
        out evaluations on its behalf, including from the scientific panel established
        pursuant to Article 68. Independent experts appointed for this task shall
        meet the criteria outlined in Article 68(2).
    - urn: urn:intuitem:risk:req_node:ai-act:92.3
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.3'
      description: For the purposes of paragraph 1, the Commission may request access
        to the general- purpose AI model concerned through APIs or further appropriate
        technical means and tools, including source code.
    - urn: urn:intuitem:risk:req_node:ai-act:92.4
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.4'
      description: The request for access shall state the legal basis, the purpose
        and reasons of the request and set the period within which the access is to
        be provided, and the fines provided for in Article 101 for failure to provide
        access.
    - urn: urn:intuitem:risk:req_node:ai-act:92.5
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.5'
      description: The providers of the general-purpose AI model concerned and, in
        the case of legal persons, companies or firms, or where they have no legal
        personality, the persons authorised to represent them by law or by their constitution,
        shall provide the access requested on behalf of the provider of the general-purpose
        AI model concerned.
    - urn: urn:intuitem:risk:req_node:ai-act:92.6
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.6'
      description: The Commission shall adopt implementing acts setting out the detailed
        arrangements and the conditions of the evaluations, including the detailed
        arrangements for involving independent experts, and the procedure for the
        selection thereof. Those implementing acts shall be adopted in accordance
        with the examination procedure referred to in Article 98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:92.7
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1042
      ref_id: '92.7'
      description: Prior to requesting access to the general-purpose AI model concerned,
        the AI Office may initiate a structured dialogue with the provider of the
        general-purpose AI model to gather more information on the internal testing
        of the model, internal safeguards for preventing systemic risks, and other
        internal procedures and measures the provider has taken to mitigate such risks.
    - urn: urn:intuitem:risk:req_node:ai-act:node1050
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 93
      description: Power to request measures
    - urn: urn:intuitem:risk:req_node:ai-act:93.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1050
      ref_id: '93.1'
      description: 'Where necessary and appropriate, the Commission may request providers
        to:

        (a) take appropriate measures to comply with the obligations set out in Article
        53;

        (b) require a provider to implement mitigation measures, where the evaluation
        carried out in accordance with Article 92 has given rise to serious and substantiated
        concern of a systemic risk at Union level;

        (c) restrict the making available on the market, withdraw or recall the model.'
    - urn: urn:intuitem:risk:req_node:ai-act:93.2
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1050
      ref_id: '93.2'
      description: Before a measure is requested, the AI Office may initiate a structured
        dialogue with the provider of the general-purpose AI model.
    - urn: urn:intuitem:risk:req_node:ai-act:93.3
      assessable: true
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1050
      ref_id: '93.3'
      description: If, during the structured dialogue referred to in paragraph 2,
        the provider of the general- purpose AI model with systemic risk offers commitments
        to implement mitigation measures to address a systemic risk at Union level,
        the Commission may, by decision, make those commitments binding and declare
        that there are no further grounds for action.
    - urn: urn:intuitem:risk:req_node:ai-act:node1054
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1025
      name: Article 94
      description: Procedural rights of economic operators of the general-purpose
        AI model
    - urn: urn:intuitem:risk:req_node:ai-act:94.1
      assessable: false
      depth: 4
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1054
      ref_id: '94.1'
      description: Article 18 of Regulation (EU) 2019/1020 shall apply mutatis mutandis
        to the providers of the general-purpose AI model, without prejudice to more
        specific procedural rights provided for in this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node1056
      assessable: false
      depth: 1
      name: CHAPTER X
      description: CODES OF CONDUCT AND GUIDELINES
    - urn: urn:intuitem:risk:req_node:ai-act:node1057
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1056
      name: Article 95
      description: Codes of conduct for voluntary application of specific requirements
    - urn: urn:intuitem:risk:req_node:ai-act:95.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1057
      ref_id: '95.1'
      description: The AI Office and the Member States shall encourage and facilitate
        the drawing up of codes of conduct, including related governance mechanisms,
        intended to foster the voluntary application to AI systems, other than high-risk
        AI systems, of some or all of the requirements set out in Chapter III, Section
        2 taking into account the available technical solutions and industry best
        practices allowing for the application of such requirements.
    - urn: urn:intuitem:risk:req_node:ai-act:95.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1057
      ref_id: '95.2'
      description: "The AI Office and the Member States shall  facilitate the drawing\
        \ up of codes of conduct concerning the voluntary application, including by\
        \ deployers, of specific requirements to all AI systems, on the basis of clear\
        \ objectives and key performance indicators to measure the achievement of\
        \ those objectives, including elements such as, but not limited to:\n(a) applicable\
        \ elements provided for in Union ethical guidelines for trustworthy AI;\n\
        (b) assessing and minimising the impact of AI systems on environmental sustainability,\
        \ including as regards energy-efficient programming and techniques for the\
        \ efficient design, training and use of AI;\n(c) promoting AI literacy, in\
        \ particular that of persons dealing with the development, operation and use\
        \ of AI;\n(d) facilitating an inclusive and diverse design of AI systems,\
        \ including through the establishment of inclusive and diverse development\
        \ teams and the promotion of stakeholders\u2019 participation in that process;\n\
        (e) assessing and preventing the negative impact of AI systems on vulnerable\
        \ persons or groups of vulnerable persons, including as regards accessibility\
        \ for persons with a disability, as well as on gender equality."
    - urn: urn:intuitem:risk:req_node:ai-act:95.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1057
      ref_id: '95.3'
      description: Codes of conduct may be drawn up by individual providers or deployers
        of AI systems or by organisations representing them or by both, including
        with the involvement of deployers and any interested stakeholders and their
        representative organisations, including civil society organisations and academia.
        Codes of conduct may cover one or more AI systems taking into account the
        similarity of the intended purpose of the relevant systems.
    - urn: urn:intuitem:risk:req_node:ai-act:95.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1057
      ref_id: '95.4'
      description: The AI Office and the Member States shall take into account the
        specific interests and needs of SMEs, including start-ups, when encouraging
        and facilitating the drawing up of codes of conduct.
    - urn: urn:intuitem:risk:req_node:ai-act:node1062
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1056
      name: Article 96
      description: Guidelines from the Commission on the implementation of this Regulation
    - urn: urn:intuitem:risk:req_node:ai-act:96.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1062
      ref_id: '96.1'
      description: 'The Commission shall develop guidelines on the practical implementation
        of this Regulation, and in particular on:

        (a) the application of the requirements and obligations referred to in Articles
        8 to 15 and in Article 25;

        (b) the prohibited practices referred to in Article 5;

        (c) the practical implementation of the provisions related to substantial
        modification;

        (d) the practical implementation of transparency obligations laid down in
        Article 50;

        (e) detailed information on the relationship of this Regulation with the Union
        harmonisation legislation listed in Annex I, as well as with other relevant
        Union law, including as regards consistency in their enforcement;

        (f) the application of the definition of an AI system as set out in Article
        3(1).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1064
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1062
      description: When issuing such guidelines, the Commission shall pay particular
        attention to the needs of SMEs including start-ups, of local public authorities
        and of the sectors most likely to be affected by this Regulation.
    - urn: urn:intuitem:risk:req_node:ai-act:node1065
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1062
      description: The guidelines referred to in the first subparagraph shall take
        due account of the generally acknowledged state of the art on AI, as well
        as of relevant harmonised standards and common specifications that are referred
        to in Articles 40 and 41, or of those harmonised standards or technical specifications
        that are set out pursuant to Union harmonisation law.
    - urn: urn:intuitem:risk:req_node:ai-act:96.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1062
      ref_id: '96.2'
      description: Upon request of the Member States or the AI Office, or on its own
        initiative, the Commission shall update guidelines previously adopted when
        deemed necessary.
    - urn: urn:intuitem:risk:req_node:ai-act:node1067
      assessable: false
      depth: 1
      name: CHAPTER XI
      description: DELEGATION OF POWER AND COMMITTEE PROCEDURE
    - urn: urn:intuitem:risk:req_node:ai-act:node1068
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1067
      name: Article 97
      description: Exercise of the delegation
    - urn: urn:intuitem:risk:req_node:ai-act:97.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.1'
      description: The power to adopt delegated acts is conferred on the Commission
        subject to the conditions laid down in this Article.
    - urn: urn:intuitem:risk:req_node:ai-act:97.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.2'
      description: The power to adopt delegated acts referred to in Article 6(6) and
        (7), Article 7(1) and (3), Article 11(3), Article 43(5) and (6), Article 47(5),
        Article 51(3), Article 52(4) and Article 53(5) and (6) shall be conferred
        on the Commission for a period of five years from 1 August 2024. The Commission
        shall draw up a report in respect of the delegation of power not later than
        nine months before the end of the five-year period. The delegation of power
        shall be tacitly extended for periods of an identical duration, unless the
        European Parliament or the Council opposes such extension not later than three
        months before the end of each period.
    - urn: urn:intuitem:risk:req_node:ai-act:97.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.3'
      description: The delegation of power referred to in Article 6(6), Article 7(1)
        and (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3),
        Article 52(4) and Article 53(5) and (6) may be revoked at any time by the
        European Parliament or by the Council. A decision of revocation shall put
        an end to the delegation of power specified in that decision. It shall take
        effect the day following that of its publication in the Official Journal of
        the European Union or at a later date specified therein. It shall not affect
        the validity of any delegated acts already in force.
    - urn: urn:intuitem:risk:req_node:ai-act:97.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.4'
      description: Before adopting a delegated act, the Commission shall consult experts
        designated by each Member State in accordance with the principles laid down
        in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
    - urn: urn:intuitem:risk:req_node:ai-act:97.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.5'
      description: As soon as it adopts a delegated act, the Commission shall notify
        it simultaneously to the European Parliament and to the Council.
    - urn: urn:intuitem:risk:req_node:ai-act:97.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1068
      ref_id: '97.6'
      description: Any delegated act adopted pursuant Article 6(6), Article 7(1) and
        (3), Article 11(3), Article 43(5) and (6), Article 47(5), Article 51(3), Article
        52(4) and Article 53(5) and (6) shall enter into force only if no objection
        has been expressed by either the European Parliament or the Council within
        a period of three months of notification of that act to the European Parliament
        and the Council or if, before the expiry of that period, the European Parliament
        and the Council have both informed the Commission that they will not object.
        That period shall be extended by three months at the initiative of the European
        Parliament or of the Council.
    - urn: urn:intuitem:risk:req_node:ai-act:node1075
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1067
      name: Article 98
      description: Committee procedure
    - urn: urn:intuitem:risk:req_node:ai-act:98.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1075
      ref_id: '98.1'
      description: The Commission shall be assisted by a committee. That committee
        shall be a committee within the meaning of Regulation (EU) No 182/2011.
    - urn: urn:intuitem:risk:req_node:ai-act:98.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1075
      ref_id: '98.2'
      description: Where reference is made to this paragraph, Article 5 of Regulation
        (EU) No 182/2011 shall apply.
    - urn: urn:intuitem:risk:req_node:ai-act:node1078
      assessable: false
      depth: 1
      name: CHAPTER XII
      description: PENALTIES
    - urn: urn:intuitem:risk:req_node:ai-act:node1079
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1078
      name: Article 99
      description: Penalties
    - urn: urn:intuitem:risk:req_node:ai-act:99.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.1'
      description: In compliance with the terms and conditions laid down in this Regulation,
        Member States shall lay down the rules on penalties and other enforcement
        measures, which may also include warnings and non-monetary measures, applicable
        to infringements of this Regulation by operators, and shall take all measures
        necessary to ensure that they are properly and effectively implemented and
        taking into account the guidelines issued by the Commission pursuant to Article
        96. The penalties provided for shall be effective, proportionate and dissuasive.
        They shall take into  account the interests of SMEs, including start-ups,
        and their economic viability.
    - urn: urn:intuitem:risk:req_node:ai-act:99.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.2'
      description: The Member States shall, without delay and at the latest by the
        date of entry into application, notify the Commission of the rules on penalties
        and of other enforcement measures referred to in paragraph 1, and shall notify
        it, without delay, of any subsequent amendment to them.
    - urn: urn:intuitem:risk:req_node:ai-act:99.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.3'
      description: Non-compliance with the prohibition of the AI practices referred
        to in Article 5 shall be subject to administrative fines of up to 35 000 000
        EUR or, if the offender is an undertaking, up to 7 % of its total worldwide
        annual turnover for the preceding financial year, whichever is higher.
    - urn: urn:intuitem:risk:req_node:ai-act:99.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.4'
      description: 'Non-compliance of an AI system with any of the following provisions
        related to operators or notified bodies, other than those laid down in Articles
        5 , shall be subject to administrative fines of up to 15 000 000 EUR or, if
        the offender is an undertaking, up to

        3 % of its total worldwide annual turnover for the preceding financial year,
        whichever is higher:

        (a) obligations of providers pursuant to Article 16;

        (b) obligations of authorised representatives pursuant to Article 22;

        (c) obligations of importers pursuant to Article 23;

        (d) obligations of distributors pursuant to Article 24;

        (e) obligations of deployers pursuant to Article 26;

        (f) requirements and obligations of notified bodies pursuant to Articles 31,
        33(1), 33(3), 33(4) or 34;

        (g) transparency obligations for providers and users pursuant to Article 50.'
    - urn: urn:intuitem:risk:req_node:ai-act:99.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.5'
      description: The supply of incorrect, incomplete or misleading information to
        notified bodies or national competent authorities in reply to a request shall
        be subject to administrative fines of up to 7 500 000 EUR or, if the offender
        is an undertaking, up to 1 % of its total worldwide annual turnover for the
        preceding financial year, whichever is higher.
    - urn: urn:intuitem:risk:req_node:ai-act:99.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.6'
      description: In the case of SMEs, including start-ups, each fine referred to
        in this Article shall be up to the percentages or amount referred to paragraphs
        3, 4 and 5, whichever thereof is lower.
    - urn: urn:intuitem:risk:req_node:ai-act:99.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.7'
      description: 'When deciding whether to impose an administrative fine and when
        deciding on the amount of the administrative fine in each individual case,
        all relevant circumstances of the specific situation shall be taken into account
        and, as appropriate, regard shall be given to the following:

        (a) the nature, gravity and duration of the infringement and of its consequences,
        taking into account the purpose of the AI system, as well as, where appropriate,
        the number of affected persons and the level of damage suffered by them;

        (b) whether administrative fines have already been applied by other market
        surveillance authorities of one or more Member States to the same operator
        for the same infringement;

        (c) whether administrative fines have already been applied by other authorities
        to the same operator for infringements of other Union or national law, when
        such infringements result from the same activity or omission constituting
        a relevant infringement of this Regulation;

        (d) the size, the annual turnover and market share of the operator committing
        the infringement;

        (e) any other aggravating or mitigating factor applicable to the circumstances
        of the case, such as financial benefits gained, or losses avoided, directly
        or indirectly, from the infringement;

        (f) the degree of cooperation with the national competent authorities, in
        order to remedy the infringement and mitigate the possible adverse effects
        of the infringement;

        (g) the degree of responsibility of the operator taking into account the technical
        and organisational measures implemented by it;

        (h) the manner in which the infringement became known to the national competent
        authorities, in particular whether, and if so to what extent, the operator
        notified the infringement;

        (i) the intentional or negligent character of the infringement;

        (j) any action taken by the operator to mitigate the harm suffered by the
        affected persons.'
    - urn: urn:intuitem:risk:req_node:ai-act:99.8
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.8'
      description: Each Member State shall lay down rules on  to what extent administrative
        fines may be imposed on public authorities and bodies established in that
        Member State.
    - urn: urn:intuitem:risk:req_node:ai-act:99.9
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.9'
      description: Depending on the legal system of the Member States, the rules on
        administrative fines may be applied in such a manner that the fines are imposed
        by competent national courts or by other bodies, as applicable in those Member
        States. The application of such rules in those Member States shall have an
        equivalent effect.
    - urn: urn:intuitem:risk:req_node:ai-act:99.10
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.10'
      description: The exercise by the market surveillance authority of its powers
        under this Article shall be subject to appropriate procedural safeguards in
        accordance with Union and national law, including effective judicial remedies
        and due process.
    - urn: urn:intuitem:risk:req_node:ai-act:99.11
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1079
      ref_id: '99.11'
      description: Member States shall, on an annual basis, report to the Commission
        about the administrative fines they have issued during that year, in accordance
        with this Article, and about any related litigation or judicial proceedings.
    - urn: urn:intuitem:risk:req_node:ai-act:node1091
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1078
      name: Article 100
      description: Administrative fines on Union institutions, bodies, offices and
        agencies
    - urn: urn:intuitem:risk:req_node:ai-act:100.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.1'
      description: 'The European Data Protection Supervisor may impose administrative
        fines on Union institutions, bodies, offices and agencies falling within the
        scope of this Regulation. When deciding whether to impose an administrative
        fine and when deciding on the amount of the administrative fine in each individual
        case, all relevant circumstances of the specific situation shall be taken
        into account and due regard shall be given to the following:

        (a) the nature, gravity and duration of the infringement and of its consequences;
        taking into account the purpose of the AI system concerned as well as the
        number of affected persons and the level of damage suffered by them, and any
        relevant previous infringement;

        (b) the degree of responsibility of the Union institution, body, office or
        agency, taking into account technical and organisational measures implemented
        by them;

        (c) any action taken by the Union institution, body, office or agency to mitigate
        the damage suffered by affected persons;

        (d) the degree of cooperation with the European Data Protection Supervisor
        in order to remedy the infringement and mitigate the possible adverse effects
        of the infringement, including compliance with any of the measures previously
        ordered by the European Data Protection Supervisor against the Union institution,
        body, office or agency concerned with regard to the same subject matter;

        (e) any similar previous infringements by the Union institution, body, office
        or agency;

        (f) the manner in which the infringement became known to the European Data
        Protection Supervisor, in particular whether, and if so to what extent, the
        Union institution, body, office or agency notified the infringement;

        (g) the annual budget of the Union institution, body, office or agency.'
    - urn: urn:intuitem:risk:req_node:ai-act:100.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.2'
      description: Non-compliance with the prohibition of the AI practices referred
        to in Article 5 shall be subject to administrative fines of up to EUR 1 500
        000.
    - urn: urn:intuitem:risk:req_node:ai-act:100.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.3'
      description: The non-compliance of the AI system with any requirements or obligations
        under this Regulation, other than those laid down in Articles 5 , shall be
        subject to administrative fines of up to  EUR 750 000.
    - urn: urn:intuitem:risk:req_node:ai-act:100.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.4'
      description: Before taking decisions pursuant to this Article, the European
        Data Protection Supervisor shall give the Union institution, body, office
        or agency which is the subject of the proceedings conducted by the European
        Data Protection Supervisor the opportunity of being heard on the matter regarding
        the possible infringement. The European Data Protection Supervisor shall base
        his or her decisions only on elements and circumstances on which the parties
        concerned have been able to comment. Complainants, if any, shall be associated
        closely with the proceedings.
    - urn: urn:intuitem:risk:req_node:ai-act:100.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.5'
      description: "The rights of defence of the parties concerned shall be fully\
        \ respected in the proceedings. They shall be entitled to have access to the\
        \ European Data Protection Supervisor\u2019s file, subject to the legitimate\
        \ interest of individuals or undertakings in the protection of their personal\
        \ data or business secrets."
    - urn: urn:intuitem:risk:req_node:ai-act:100.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.6'
      description: Funds collected by imposition of fines in this Article shall contribute
        to the general budget of the Union. The fines shall not affect the effective
        operation of the Union institution, body, office or agency fined.
    - urn: urn:intuitem:risk:req_node:ai-act:100.7
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1091
      ref_id: '100.7'
      description: The European Data Protection Supervisor shall, on an annual basis,
        notify the Commission of the administrative fines it has imposed pursuant
        to this Article and of any litigation or judicial proceedings it has initiated.
    - urn: urn:intuitem:risk:req_node:ai-act:node1099
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1078
      name: Article 101
      description: Fines for providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:101.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.1'
      description: 'The Commission may impose on providers of general purpose AI models
        fines not exceeding 3 % of their total worldwide turnover in the preceding
        financial year or 15 million EUR, whichever is higher., when the Commission
        finds that the provider intentionally or negligently:

        (a) infringed the relevant provisions of this Regulation;

        (b) failed to comply with a request for a document or for information pursuant
        to Article 91, or supplied incorrect, incomplete or misleading information;

        (c) failed to comply with a measure requested under Article 93;

        (d) failed to make available to the Commission access to the general-purpose
        AI model or general-purpose AI model with systemic risk with a view to conducting
        an evaluation pursuant to Article 92.

        In fixing the amount of the fine or periodic penalty payment, regard shall
        be had to the nature, gravity and duration of the infringement, taking due
        account of the principles of proportionality and appropriateness. The Commission
        shall also into account commitments made in accordance with Article 93(3)
        or made in relevant codes of practice in accordance with Article 56.'
    - urn: urn:intuitem:risk:req_node:ai-act:101.2
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.2'
      description: Before adopting the decision pursuant to paragraph 1, the Commission
        shall communicate its preliminary findings to the provider of the general-purpose
        AI model or general-purpose AI model with systemic risk and give it an opportunity
        to be heard.
    - urn: urn:intuitem:risk:req_node:ai-act:101.3
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.3'
      description: Fines imposed in accordance with this Article shall be effective,
        proportionate and dissuasive.
    - urn: urn:intuitem:risk:req_node:ai-act:101.4
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.4'
      description: Information on fines imposed under this Article shall also be communicated
        to the Board as appropriate.
    - urn: urn:intuitem:risk:req_node:ai-act:101.5
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.5'
      description: The Court of Justice of the European Union shall have unlimited
        jurisdiction to review decisions of the Commission fixing a fine under this
        Article. It may cancel, reduce or increase the fine imposed.
    - urn: urn:intuitem:risk:req_node:ai-act:101.6
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1099
      ref_id: '101.6'
      description: The Commission shall adopt implementing acts containing detailed
        arrangements for proceedings in view of the possible adoption of decisions
        pursuant to paragraph 1 of this Article. Those implementing acts shall be
        adopted in accordance with the examination procedure referred to in Article
        98(2).
    - urn: urn:intuitem:risk:req_node:ai-act:node1106
      assessable: false
      depth: 1
      name: CHAPTER XIII
      description: 'FINAL PROVISIONS '
    - urn: urn:intuitem:risk:req_node:ai-act:node1107
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 102
      description: 'Amendment to Regulation (EC) No 300/2008 '
    - urn: urn:intuitem:risk:req_node:ai-act:node1108
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1107
      description: "In Article 4(3) of Regulation (EC) No 300/2008, the following\
        \ subparagraph is added:\n\u2018When adopting detailed measures related to\
        \ technical specifications and procedures for approval and use of security\
        \ equipment concerning Artificial Intelligence systems within the meaning\
        \ of Regulation (EU) 2024/1689 of the European Parliament and of the Council,\
        \ the requirements set out in Title III, Chapter 2 of that Regulation shall\
        \ be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1109
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 103
      description: Amendment to Regulation (EU) No 167/2013
    - urn: urn:intuitem:risk:req_node:ai-act:103.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1109
      ref_id: '103.1'
      description: "In Article 17(5) of Regulation (EU) No 167/2013, the following\
        \ subparagraph is added:\n\u2018When adopting delegated acts pursuant to the\
        \ first subparagraph concerning artificial intelligence systems which are\
        \ safety components within the meaning of Regulation (EU) 2024/1689 of the\
        \ European Parliament and of the Council, the requirements set out in Title\
        \ III, Chapter 2 of that Regulation shall be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1111
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 104
      description: Amendment to Regulation (EU) No 168/2013
    - urn: urn:intuitem:risk:req_node:ai-act:104.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1111
      ref_id: '104.1'
      description: "In Article 22(5) of Regulation (EU) No 168/2013, the following\
        \ subparagraph is added:\n\u2018When adopting delegated acts pursuant to the\
        \ first subparagraph concerning Artificial Intelligence systems which are\
        \ safety components within the meaning of Regulation (EU) 2024/1689 of the\
        \ European Parliament and of the Council, the requirements set out in Title\
        \ III, Chapter 2 of that Regulation shall be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1113
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 105
      description: Amendment to Directive 2014/90/EU
    - urn: urn:intuitem:risk:req_node:ai-act:105.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1113
      ref_id: '105.1'
      description: "In Article 8 of Directive 2014/90/EU, the following paragraph\
        \ is added:\n\u20185. For Artificial Intelligence systems which are safety\
        \ components within the meaning of Regulation (EU) 2024/1689 of the European\
        \ Parliament and of the Council, when carrying out its activities pursuant\
        \ to paragraph 1 and when adopting technical specifications and testing standards\
        \ in accordance with paragraphs 2 and 3, the Commission shall take into account\
        \ the requirements set out in Title III, Chapter 2 of that Regulation."
    - urn: urn:intuitem:risk:req_node:ai-act:node1115
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 106
      description: Amendment to Directive (EU) 2016/797
    - urn: urn:intuitem:risk:req_node:ai-act:106.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1115
      ref_id: '106.1'
      description: "In Article 5 of Directive (EU) 2016/797, the following paragraph\
        \ is added:\n\u201812. When adopting delegated acts pursuant to paragraph\
        \ 1 and implementing acts pursuant to paragraph 11 concerning Artificial Intelligence\
        \ systems which are safety components within the meaning of Regulation (EU)\
        \ 2024/1689 of the European Parliament and of the Council, the requirements\
        \ set out in Title III, Chapter 2 of that Regulation shall be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1117
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 107
      description: Amendment to Regulation (EU) 2018/858
    - urn: urn:intuitem:risk:req_node:ai-act:107.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1117
      ref_id: '107.1'
      description: "In Article 5 of Regulation (EU) 2018/858 the following paragraph\
        \ is added:\n\u20184. When adopting delegated acts pursuant to paragraph 3\
        \ concerning Artificial Intelligence systems which are safety components within\
        \ the meaning of Regulation (EU) 2024/1689 of the European Parliament and\
        \ of the Council, the requirements set out in Title III, Chapter 2 of that\
        \ Regulation shall be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1119
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 108
      description: Amendment to Regulation (EU) 2018/1139
    - urn: urn:intuitem:risk:req_node:ai-act:108.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1119
      ref_id: '108.1'
      description: "Regulation (EU) 2018/1139 is amended as follows:\n(1) in Article\
        \ 17, the following paragraph is added:\n\u20183. Without prejudice to paragraph\
        \ 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial\
        \ Intelligence systems which are safety components within the meaning of Regulation\
        \ (EU) 2024/1689 of the European Parliament and of the Council, the requirements\
        \ set out in Title III, Chapter 2 of that Regulation shall be taken into account.\n\
        the Council*+, the requirements set out in Title III, Chapter 2 of that Regulation\
        \ shall be taken into account.\n(2) in Article 19, the following paragraph\
        \ is added:\n\u20184. When adopting delegated acts pursuant to paragraphs\
        \ 1 and 2 concerning Artificial Intelligence systems which are safety components\
        \ within the meaning of Regulation (EU) 2024/1689, the requirements set out\
        \ in Title III, Chapter 2 of that Regulation shall be taken into account.\u2019\
        ;\n(3) in Article 43, the following paragraph is added:\n\u20184. When adopting\
        \ implementing acts pursuant to paragraph 1 concerning Artificial Intelligence\
        \ systems which are safety components within the meaning of Regulation (EU)\
        \ 2024/1689, the requirements set out in Title III, Chapter 2 of that Regulation\
        \ shall be taken into account.\u2019;\n(4) in Article 47, the following paragraph\
        \ is added:\n\u20183. When adopting delegated acts pursuant to paragraphs\
        \ 1 and 2 concerning Artificial Intelligence systems which are safety components\
        \ within the meaning of Regulation (EU) 2024/1689, the requirements set out\
        \ in Title III, Chapter 2 of that Regulation shall be taken into account.\u2019\
        ;\n(5) in Article 57, the following subparagraph is added:\n\u2018When adopting\
        \ those implementing acts concerning Artificial Intelligence systems which\
        \ are safety components within the meaning of Regulation (EU) 2024/1689, the\
        \ requirements set out in Title III, Chapter 2 of that Regulation shall be\
        \ taken into account.\u2019;\n(6) in Article 58, the following paragraph is\
        \ added:\n\u20183. When adopting delegated acts pursuant to paragraphs 1 and\
        \ 2 concerning Artificial Intelligence systems which are safety components\
        \ within the meaning of Regulation (EU) 2024/1689, the requirements set out\
        \ in Title III, Chapter 2 of that Regulation shall be taken into account.\u2019\
        ."
    - urn: urn:intuitem:risk:req_node:ai-act:node1121
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 109
      description: Amendment to Regulation (EU) 2019/2144
    - urn: urn:intuitem:risk:req_node:ai-act:109.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1121
      ref_id: '109.1'
      description: "In Article 11 of Regulation (EU) 2019/2144, the following paragraph\
        \ is added:\n\u20183.   When adopting the implementing acts pursuant to paragraph\
        \ 2, concerning artificial intelligence systems which are safety components\
        \ within the meaning of Regulation (EU) 2024/1689 of the European Parliament\
        \ and of the Council (*8), the requirements set out in Chapter III, Section\
        \ 2, of that Regulation shall be taken into account."
    - urn: urn:intuitem:risk:req_node:ai-act:node1123
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 110
      description: Amendment to Directive (EU) 2020/1828
    - urn: urn:intuitem:risk:req_node:ai-act:110.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1123
      ref_id: '110.1'
      description: "In Annex I to Directive (EU) 2020/1828 of the European Parliament\
        \ and of the Council (58), the following point is added:\n\u2018(68) Regulation\
        \ (EU) 2024/1689 of the European Parliament and of the Council of 13 June\
        \ 2024 laying down harmonised rules on artificial intelligence and amending\
        \ Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858,\
        \ (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797\
        \ and (EU) 2020/1828 (Artificial Intelligence Act) (OJ L, 2024/1689, 12.7.2024,\
        \ ELI: http://data.europa.eu/eli/reg/2024/1689/oj).\u2019."
    - urn: urn:intuitem:risk:req_node:ai-act:node1125
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 111
      description: AI systems already placed on the market or put into service
    - urn: urn:intuitem:risk:req_node:ai-act:111.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1125
      ref_id: '111.1'
      description: '1.   Without prejudice to the application of Article 5 as referred
        to in Article 113(3), point (a), AI systems which are components of the large-scale
        IT systems established by the legal acts listed in Annex X that have been
        placed on the market or put into service before 2 August 2027 shall be brought
        into compliance with this Regulation by 31 December 2030.

        The requirements laid down in this Regulation shall be taken into account
        in the evaluation of each large-scale IT system established by the legal acts
        listed in Annex X to be undertaken as provided for in those legal acts and
        where those legal acts are replaced or amended.

        2.   Without prejudice to the application of Article 5 as referred to in Article
        113(3), point (a), this Regulation shall apply to operators of high-risk AI
        systems, other than the systems referred to in paragraph 1 of this Article,
        that have been placed on the market or put into service before 2 August 2026,
        only if, as from that date, those systems are subject to significant changes
        in their designs. In any case, the providers and deployers of high-risk AI
        systems intended to be used by public authorities shall take the necessary
        steps to comply with the requirements and obligations of this Regulation by
        2 August 2030.

        3.   Providers of general-purpose AI models that have been placed on the market
        before 2 August 2025 shall take the necessary steps in order to comply with
        the obligations laid down in this Regulation by 2 August 2027.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1127
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 112
      description: Evaluation and review
    - urn: urn:intuitem:risk:req_node:ai-act:112.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1127
      ref_id: '112.1'
      description: '1. The Commission shall assess the need for amendment of the list
        set out in Annex III and of the list of prohibited AI practices laid down
        in Article 5, once a year following the entry into force of this Regulation,
        and until the end of the period of the delegation of power laid down in Article
        97. The Commission shall submit the findings of that assessment to the European
        Parliament and the Council.

        2. By 2 August 2028 and every four years thereafter, the Commission shall
        evaluate and report to the European Parliament and to the Council on the following:

        (a) the need for amendments extending existing area headings or adding new
        area headings in Annex III;

        (b) amendments to the list of AI systems requiring additional transparency
        measures in Article 50;

        (c) amendments enhancing the effectiveness of the supervision and governance
        system.

        3. By 2 August 2029 and every four years thereafter, the Commission shall
        submit a report on the evaluation and review of this Regulation to the European
        Parliament and to the Council. The report shall include an assessment with
        regard to the structure of enforcement and the possible need for a Union agency
        to resolve any identified shortcomings. On the basis of the findings, that
        report shall, where appropriate, be accompanied by a proposal for amendment
        of this Regulation. The reports shall be made public.

        4. The reports referred to in paragraph 2 shall pay specific attention to
        the following:

        (a) the status of the financial, technical and human resources of the national
        competent authorities in order to effectively perform the tasks assigned to
        them under this Regulation;

        (b) the state of penalties, in particular administrative fines as referred
        to in Article 99(1), applied by Member States for infringements of this Regulation;

        (c) adopted harmonised standards and common specifications developed to support
        this Regulation;

        (d) the number of undertakings that enter the market after the entry into
        application of this Regulation, and how many of them are SMEs.

        5. By 2 August 2028, the Commission shall evaluate the functioning of the
        AI Office, whether the AI Office has been given sufficient powers and competences
        to fulfil its tasks, and whether it would be relevant and needed for the proper
        implementation and enforcement of this Regulation to upgrade the AI Office
        and its enforcement competences and to increase its resources. The Commission
        shall submit a report on its evaluation to the European Parliament and to
        the Council.

        6. By 2 August 2028 and every four years thereafter, the Commission shall
        submit a report on the review of the progress on the development of standardisation
        deliverables on the energy-efficient development of general-purpose AI models,
        and asses the need for further measures or actions, including binding measures
        or actions. The report shall be submitted to the European Parliament and to
        the Council, and it shall be made public.

        7. By 2 August 2028 and every three years thereafter, the Commission shall
        evaluate the impact and effectiveness of voluntary codes of conduct to foster
        the application of the requirements set out in Chapter III, Section 2 for
        AI systems other than high-risk AI systems and possibly other additional requirements
        for AI systems other than high-risk AI systems, including as regards environmental
        sustainability.

        8. For the purposes of paragraphs 1 to 7, the Board, the Member States and
        national competent authorities shall provide the Commission with information
        upon its request and without undue delay.

        9. In carrying out the evaluations and reviews referred to in paragraphs 1
        to 7, the Commission shall take into account the positions and findings of
        the Board, of the European Parliament, of the Council, and of other relevant
        bodies or sources.

        10. The Commission shall, if necessary, submit appropriate proposals to amend
        this Regulation, in particular taking into account developments in technology,
        the effect of AI systems on health and safety, and on fundamental rights,
        and in light of the state of progress in the information society.

        11. To guide the evaluations and reviews referred to in paragraphs 1 to 7
        of this Article, the AI Office shall undertake to develop an objective and
        participative methodology for the evaluation of risk levels based on the criteria
        outlined in the relevant Articles and the inclusion of new systems in:

        (a) the list set out in Annex III, including the extension of existing area
        headings or the addition of new area headings in that Annex;

        (b) the list of prohibited practices set out in Article 5; and

        (c) the list of AI systems requiring additional transparency measures pursuant
        to Article 50.

        12. Any amendment to this Regulation pursuant to paragraph 10, or relevant
        delegated or implementing acts, which concerns sectoral Union harmonisation
        legislation listed in Section B of Annex I shall take into account the regulatory
        specificities of each sector, and the existing governance, conformity assessment
        and enforcement mechanisms and authorities established therein.

        13. By 2 August 2031, the Commission shall carry out an assessment of the
        enforcement of this Regulation and shall report on it to the European Parliament,
        the Council and the European Economic and Social Committee, taking into account
        the first years of application of this Regulation. On the basis of the findings,
        that report shall, where appropriate, be accompanied by a proposal for amendment
        of this Regulation with regard to the structure of enforcement and the need
        for a Union agency to resolve any identified shortcomings.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1129
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1106
      name: Article 113
      description: 'Entry into force and application '
    - urn: urn:intuitem:risk:req_node:ai-act:113.1
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1129
      ref_id: '113.1'
      description: 'This Regulation shall enter into force on the twentieth day following
        that of its publication in the Official Journal of the European Union.

        It shall apply from 2 August 2026.

        However:

        (a) Chapters I and II shall apply from 2 February 2025;

        (b) Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article
        78 shall apply from 2 August 2025, with the exception of Article 101;

        (c) Article 6(1) and the corresponding obligations in this Regulation shall
        apply from 2 August 2027.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1131
      assessable: true
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1129
      description: "This Regulation shall be binding in its entirety and directly\
        \ applicable in all Member States. \nDone at Brussels, 13 June 2024."
    - urn: urn:intuitem:risk:req_node:ai-act:node1132
      assessable: false
      depth: 1
      name: 'ANNEX I '
      description: List of Union harmonisation legislation
    - urn: urn:intuitem:risk:req_node:ai-act:node1133
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1132
      description: 'Section A. List of Union harmonisation legislation based on the
        New Legislative Framework

        1. Directive 2006/42/EC of the European Parliament and of the Council of 17
        May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006,
        p. 24) [as repealed by the Machinery Regulation];

        2. Directive 2009/48/EC of the European Parliament and of the Council of 18
        June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);

        3. Directive 2013/53/EU of the European Parliament and of the Council of 20
        November 2013 on recreational craft and personal watercraft and repealing
        Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);

        4. Directive 2014/33/EU of the European Parliament and of the Council of 26
        February 2014 on the harmonisation of the laws of the Member States relating
        to lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);

        5. Directive 2014/34/EU of the European Parliament and of the Council of 26
        February 2014 on the harmonisation of the laws of the Member States relating
        to equipment and protective systems intended for use in potentially explosive
        atmospheres (OJ L 96, 29.3.2014, p. 309);

        6. Directive 2014/53/EU of the European Parliament and of the Council of 16
        April 2014 on the harmonisation of the laws of the Member States relating
        to the making available on the market of radio equipment and repealing Directive
        1999/5/EC (OJ L 153, 22.5.2014,

        p. 62);

        7. Directive 2014/68/EU of the European Parliament and of the Council of 15
        May 2014 on the harmonisation of the laws of the Member States relating to
        the making available on the market of pressure equipment (OJ L 189, 27.6.2014,
        p. 164);

        8. Regulation (EU) 2016/424 of the European Parliament and of the Council
        of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC
        (OJ L 81, 31.3.2016, p. 1);

        9. Regulation (EU) 2016/425 of the European Parliament and of the Council
        of 9 March 2016 on personal protective equipment and repealing Council Directive
        89/686/EEC (OJ L 81, 31.3.2016, p. 51);

        10. Regulation (EU) 2016/426 of the European Parliament and of the Council
        of 9 March 2016 on appliances burning gaseous fuels and repealing Directive
        2009/142/EC (OJ L 81, 31.3.2016, p. 99);

        11. Regulation (EU) 2017/745 of the European Parliament and of the Council
        of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation
        (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives
        90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1);

        12. Regulation (EU) 2017/746 of the European Parliament and of the Council
        of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive
        98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

        Section B. List of other Union harmonisation legislation

        13. Regulation (EC) No 300/2008 of the European Parliament and of the Council
        of

        11 March 2008 on common rules in the field of civil aviation security and
        repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72);

        14. Regulation (EU) No 168/2013 of the European Parliament and of the Council
        of

        15 January 2013 on the approval and market surveillance of two- or three-wheel
        vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);

        15. Regulation (EU) No 167/2013 of the European Parliament and of the Council
        of

        5 February 2013 on the approval and market surveillance of agricultural and
        forestry vehicles (OJ L 60, 2.3.2013, p. 1);

        16. Directive 2014/90/EU of the European Parliament and of the Council of
        23 July 2014 on marine equipment and repealing Council Directive 96/98/EC
        (OJ L 257, 28.8.2014,

        p. 146);

        17. Directive (EU) 2016/797 of the European Parliament and of the Council
        of 11 May 2016 on the interoperability of the rail system within the European
        Union (OJ L 138, 26.5.2016, p. 44);

        18. Regulation (EU) 2018/858 of the European Parliament and of the Council
        of 30 May 2018 on the approval and market surveillance of motor vehicles and
        their trailers, and of systems, components and separate technical units intended
        for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009
        and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1);

        19. Regulation (EU) 2019/2144 of the European Parliament and of the Council
        of

        27 November 2019 on type-approval requirements for motor vehicles and their
        trailers, and systems, components and separate technical units intended for
        such vehicles, as regards their general safety and the protection of vehicle
        occupants and vulnerable road users, amending Regulation (EU) 2018/858 of
        the European Parliament and of the Council and repealing Regulations (EC)
        No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament
        and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010,
        (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010,
        (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU)
        No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No
        1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1);

        20. Regulation (EU) 2018/1139 of the European Parliament and of the Council
        of 4 July 2018 on common rules in the field of civil aviation and establishing
        a European Union Aviation Safety Agency, and amending Regulations (EC) No
        2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives
        2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and
        repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European
        Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ
        L 212, 22.8.2018, p. 1), in so far as the design, production and placing on
        the market of aircrafts referred to in Article 2(1), points (a) and (b) thereof,
        where it concerns unmanned aircraft and their engines, propellers, parts and
        equipment to control them remotely, are concerned.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1134
      assessable: false
      depth: 1
      name: 'ANNEX II '
      description: List of criminal offences referred to in Article 5(1), point (e)(iii)
    - urn: urn:intuitem:risk:req_node:ai-act:node1135
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1134
      description: "Criminal offences referred to in Article 5(1), point (e)(iii):\n\
        \u2013 terrorism,\n\u2013 trafficking in human beings,\n\u2013 sexual exploitation\
        \ of children, and child pornography,\n\u2013 illicit trafficking in narcotic\
        \ drugs or psychotropic substances,\n\u2013 illicit trafficking in weapons,\
        \ munitions or explosives,\n\u2013 murder, grievous bodily injury,\n\u2013\
        \ illicit trade in human organs or tissue,\n\u2013 illicit trafficking in\
        \ nuclear or radioactive materials,\n\u2013 kidnapping, illegal restraint\
        \ or hostage-taking,\n\u2013 crimes within the jurisdiction of the International\
        \ Criminal Court,\n\u2013 unlawful seizure of aircraft or ships,\n\u2013 rape,\n\
        \u2013 environmental crime,\n\u2013 organised or armed robbery,\n\u2013 sabotage,\n\
        \u2013 participation in a criminal organisation involved in one or more of\
        \ the offences listed above."
    - urn: urn:intuitem:risk:req_node:ai-act:node1136
      assessable: false
      depth: 1
      name: 'ANNEX III '
      description: High-risk AI systems referred to in Article 6(2)
    - urn: urn:intuitem:risk:req_node:ai-act:node1137
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: 'High-risk AI systems pursuant to Article 6(2) are the AI systems
        listed in any of the following areas:

        1. Biometrics, in so far as their use is permitted under relevant Union or
        national law:

        (a) remote biometric identification systems.

        This shall not include AI systems intended to be used for biometric verification
        the sole purpose of which is to confirm that a specific natural person is
        the person he or she claims to be;

        (b) AI systems intended to be used for biometric categorisation, according
        to sensitive or protected attributes or characteristics based on the inference
        of those attributes or characteristics;

        (c) AI systems intended to be used for emotion recognition.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1138
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '2. Critical infrastructure:

        (a) AI systems intended to be used as safety components in the management
        and operation of critical digital infrastructure, road traffic, or in the
        supply of water, gas, heating or electricity.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1139
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '3. Education and vocational training:

        (a) AI systems intended to be used to determine access or admission or to
        assign

        natural persons to educational and vocational training institutions at all
        levels;

        (b) AI systems intended to be used to evaluate learning outcomes, including
        when those outcomes are used to steer the learning process of natural persons
        in educational and vocational training institutions at all levels;

        (c) AI systems intended to be used for the purpose of assessing the appropriate
        level of education that an individual will receive or will be able to access,
        in the context of or within educational and vocational training institutions;

        (d) AI systems intended to be used for monitoring and detecting prohibited
        behaviour of students during tests in the context of or within educational
        and vocational training institutions.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1140
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '4. Employment, workers management and access to self-employment:

        (a) AI systems intended to be used for the recruitment or selection of natural
        persons, in particular to place targeted job advertisements, to analyse and
        filter job applications, and to evaluate candidates;

        (b) AI systems intended to be used to make decisions affecting terms of work-related
        relationships, the promotion or termination of work-related contractual relationships,
        to allocate tasks based on individual behaviour or personal traits or characteristics
        or to monitor and evaluate the performance and behaviour of persons in such
        relationships.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1141
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '

        5. Access to and enjoyment of essential private services and essential public
        services and benefits:

        (a) AI systems intended to be used by public authorities or on behalf of public
        authorities to evaluate the eligibility of natural persons for essential public
        assistance benefits and services, including healthcare services, as well as
        to grant, reduce, revoke, or reclaim such benefits and services;

        (b) AI systems intended to be used to evaluate the creditworthiness of natural
        persons or establish their credit score, with the exception of AI systems
        used for the purpose of detecting financial fraud;

        (c) AI systems intended to be used for risk assessment and pricing in relation
        to natural persons in the case of life and health insurance;

        (d) AI systems intended to evaluate and classify emergency calls by natural
        persons or to be used to dispatch, or to establish priority in the dispatching
        of, emergency first response services, including by police, firefighters and
        medical aid, as well as of emergency healthcare patient triage systems;'
    - urn: urn:intuitem:risk:req_node:ai-act:node1142
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: "6. Law enforcement, in so far as their use is permitted under\
        \ relevant Union or national law:\n(a) AI systems intended to be used by or\
        \ on behalf of law enforcement authorities, or by Union institutions, bodies,\
        \ offices or agencies in support of law enforcement authorities or on their\
        \ behalf to assess a natural person\u2019s risk of becoming the victim of\
        \ criminal offences;\n(b) AI systems intended to be used by or on behalf of\
        \ law enforcement authorities or by Union institutions, bodies, offices or\
        \ agencies in support of law enforcement authorities as polygraphs or similar\
        \ tools;\n(c)AI systems intended to be used by or on behalf of law enforcement\
        \ authorities, or by Union institutions, bodies, offices or agencies, in support\
        \ of law enforcement authorities to evaluate the reliability of evidence in\
        \ the course of the investigation or prosecution of criminal offences;\n(d)\
        \ AI systems intended to be used by law enforcement authorities or on their\
        \ behalf or by Union institutions, bodies, offices or agencies in support\
        \ of law enforcement authorities for assessing the likelihood of a natural\
        \ person of offending or re- offending not solely based on profiling of natural\
        \ persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to\
        \ assess personality traits and characteristics or past criminal behaviour\
        \ of natural persons or groups;\n(e) AI systems intended to be used by or\
        \ on behalf of law enforcement authorities or by Union institutions, bodies,\
        \ offices or agencies in support of law enforcement authorities for the profiling\
        \ of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680\
        \ in the course of the detection, investigation or prosecution of criminal\
        \ offences."
    - urn: urn:intuitem:risk:req_node:ai-act:node1143
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '7. Migration, asylum and border control management, in so far
        as their use is permitted under relevant Union or national law:

        (a) AI systems intended to be used by competent public authorities as polygraphs
        and similar tools;

        (b) AI systems intended to be used by or on behalf of competent public authorities
        or by Union institutions, bodies, offices or agencies to assess a risk, including
        a security risk, a risk of irregular migration, or a health risk, posed by
        a natural person who intends to enter or who has entered into the territory
        of a Member State;

        (c) AI systems intended to be used by or on behalf of competent public authorities
        or by Union institutions, bodies, offices or agencies to assist competent
        public authorities for the examination of applications for asylum, visa or
        residence permits and for associated complaints with regard to the eligibility
        of the natural persons applying for a status, including related assessments
        of the reliability of evidence;

        (d) AI systems intended to be used by or on behalf of competent public authorities,
        including Union institutions, bodies, offices or agencies, in the context
        of migration, asylum or border control management, for the purpose of detecting,
        recognising or identifying natural persons, with the exception of the verification
        of travel documents.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1144
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1136
      description: '8. Administration of justice and democratic processes:

        (a) AI systems intended to be used by a judicial authority or on their behalf
        to assist a judicial authority in researching and interpreting facts and the
        law and in applying the law to a concrete set of facts, or to be used in a
        similar way in alternative dispute resolution;

        (b) AI systems intended to be used for influencing the outcome of an election
        or referendum or the voting behaviour of natural persons in the exercise of
        their vote in elections or referenda. This does not include AI systems to
        the output of which natural persons are not directly exposed, such as tools
        used to organise, optimise or structure political campaigns from an administrative
        or logistical point of view.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1145
      assessable: false
      depth: 1
      name: ANNEX IV
      description: Technical documentation referred to in Article 11(1)
    - urn: urn:intuitem:risk:req_node:ai-act:node1146
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 'The technical documentation referred to in Article 11(1) shall
        contain at least the following information, as applicable to the relevant
        AI system:

        1. A general description of the AI system including:

        (a) its intended purpose, the name of the provider and the version of the
        system

        reflecting its relation to previous versions;

        (b) how the AI system interacts with, or can be used to interact with, hardware
        or software, including with other AI systems, that are not part of the AI
        system itself, where applicable;

        (c) the versions of relevant software or firmware, and any requirements related
        to version updates;

        (d) the description of all the forms in which the AI system is placed on the
        market or put into service, such as software packages embedded into hardware,
        downloads, or APIs;

        (e) the description of the hardware on which the AI system is intended to
        run;

        (f) where the AI system is a component of products, photographs or illustrations
        showing external features, the marking and internal layout of those products;

        (g) a basic description of the user-interface provided to the deployer;

        (h) instructions for use for the deployer, and a basic description of the
        user-interface

        provided to the deployer, where applicable ;'
    - urn: urn:intuitem:risk:req_node:ai-act:node1147
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: '2. A detailed description of the elements of the AI system and
        of the process for its

        development, including:

        (a) the methods and steps performed for the development of the AI system,
        including, where relevant, recourse to pre-trained systems or tools provided
        by third parties and how those were used, integrated or modified by the provider;

        (b) the design specifications of the system, namely the general logic of the
        AI system and of the algorithms; the key design choices including the rationale
        and assumptions made, including with regard to persons or groups of persons
        in respect of who, the system is intended to be used; the main classification
        choices; what the system is designed to optimise for, and the relevance of
        the different parameters; the description of the expected output and output
        quality of the system; the decisions about any possible trade-off made regarding
        the technical solutions adopted to comply with the requirements set out in
        Chapter III, Section 2;

        (c) the description of the system architecture explaining how software components
        build on or feed into each other and integrate into the overall processing;
        the computational resources used to develop, train, test and validate the
        AI system;

        (d) where relevant, the data requirements in terms of datasheets describing
        the training methodologies and techniques and the training data sets used,
        including a general description of these data sets, information about their
        provenance, scope and main characteristics; how the data was obtained and
        selected; labelling procedures (e.g. for supervised learning), data cleaning
        methodologies (e.g. outliers detection);

        (e) assessment of the human oversight measures needed in accordance with Article
        14, including an assessment of the technical measures needed to facilitate
        the interpretation of the outputs of AI systems by the deployers, in accordance
        with Article 13(3), point (d);

        (f) where applicable, a detailed description of pre-determined changes to
        the AI system and its performance, together with all the relevant information
        related to the technical solutions adopted to ensure continuous compliance
        of the AI system with the relevant requirements set out in Chapter III, Section
        2;

        (g) the validation and testing procedures used, including information about
        the validation and testing data used and their main characteristics; metrics
        used to measure accuracy, robustness  and compliance with other relevant requirements
        set out in Chapter III, Section 2, as well as potentially discriminatory impacts;
        test logs and all test reports dated and signed by the responsible persons,
        including with regard to pre- determined changes as referred to under point
        (f);

        (h) cybersecurity measures put in place;'
    - urn: urn:intuitem:risk:req_node:ai-act:node1148
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: '3. Detailed information about the monitoring, functioning and
        control of the AI system, in particular with regard to: its capabilities and
        limitations in performance, including the degrees of accuracy for specific
        persons or groups of persons on which the system is intended to be used and
        the overall expected level of accuracy in relation to its intended purpose;
        the foreseeable unintended outcomes and sources of risks to health and safety,
        fundamental rights and discrimination in view of the intended purpose of the
        AI system; the human oversight measures needed in accordance with Article
        14, including the technical measures put in place to facilitate the interpretation
        of the outputs of AI systems by the deployers; specifications on input data,
        as appropriate;'
    - urn: urn:intuitem:risk:req_node:ai-act:node1149
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 4. A description of the appropriateness of the performance metrics
        for the specific AI system;
    - urn: urn:intuitem:risk:req_node:ai-act:node1150
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 5. A detailed description of the risk management system in accordance
        with Article 9;
    - urn: urn:intuitem:risk:req_node:ai-act:node1151
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 6. A description of relevant changes made by the provider to the
        system through its lifecycle;
    - urn: urn:intuitem:risk:req_node:ai-act:node1152
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 7. A list of the harmonised standards applied in full or in part
        the references of which have been published in the Official Journal of the
        European Union; where no such harmonised standards have been applied, a detailed
        description of the solutions adopted to meet the requirements set out in Chapter
        III, Section 2, including a list of other relevant standards and technical
        specifications applied;
    - urn: urn:intuitem:risk:req_node:ai-act:node1153
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 8. A copy of the EU declaration of conformity;
    - urn: urn:intuitem:risk:req_node:ai-act:node1154
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1145
      description: 9. A detailed description of the system in place to evaluate the
        AI system performance in the post-market phase in accordance with Article
        72, including the post-market monitoring plan referred to in Article 72(3).
    - urn: urn:intuitem:risk:req_node:ai-act:node1155
      assessable: false
      depth: 1
      name: ANNEX V
      description: EU declaration of conformity
    - urn: urn:intuitem:risk:req_node:ai-act:node1156
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 'The EU declaration of conformity referred to in Article 47, shall
        contain all of the following information:

        1. AI system name and type and any additional unambiguous reference allowing
        the identification and traceability of the AI system;'
    - urn: urn:intuitem:risk:req_node:ai-act:node1157
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 2. The name and address of the provider or, where applicable, of
        their authorised representative;
    - urn: urn:intuitem:risk:req_node:ai-act:node1158
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 3. A statement that the EU declaration of conformity is issued
        under the sole responsibility of the provider;
    - urn: urn:intuitem:risk:req_node:ai-act:node1159
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 4. A statement that the AI system is in conformity with this Regulation
        and, if applicable, with any other relevant Union law that provides for the
        issuing of an EU declaration of conformity;
    - urn: urn:intuitem:risk:req_node:ai-act:node1160
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 5. Where an AI system involves the processing of personal data,
        a statement that that AI system complies with Regulations (EU) 2016/679 and
        (EU) 2018/1725 and Directive (EU) 2016/680;
    - urn: urn:intuitem:risk:req_node:ai-act:node1161
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 6. References to any relevant harmonised standards used or any
        other common specification in relation to which conformity is declared;
    - urn: urn:intuitem:risk:req_node:ai-act:node1162
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 7. Where applicable, the name and identification number of the
        notified body, a description of the conformity assessment procedure performed,
        and identification of the certificate issued;
    - urn: urn:intuitem:risk:req_node:ai-act:node1163
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1155
      description: 8. The place and date of issue of the declaration, the name and
        function of the person who signed it, as well as an indication for, or on
        behalf of, whom that person signed, a signature.
    - urn: urn:intuitem:risk:req_node:ai-act:node1164
      assessable: false
      depth: 1
      name: ANNEX VI
      description: Conformity assessment procedure based on internal control
    - urn: urn:intuitem:risk:req_node:ai-act:node1165
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1164
      description: 1. The conformity assessment procedure based on internal control
        is the conformity assessment procedure based on points 2 to 4.
    - urn: urn:intuitem:risk:req_node:ai-act:node1166
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1164
      description: 2. The provider verifies that the established quality management
        system is in compliance with the requirements of Article 17.
    - urn: urn:intuitem:risk:req_node:ai-act:node1167
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1164
      description: 3. The provider examines the information contained in the technical
        documentation in order to assess the compliance of the AI system with the
        relevant essential requirements set out in Chapter III, Section 2.
    - urn: urn:intuitem:risk:req_node:ai-act:node1168
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1164
      description: 4. The provider also verifies that the design and development process
        of the AI system and its post-market monitoring as referred to in Article
        72 is consistent with the technical documentation.
    - urn: urn:intuitem:risk:req_node:ai-act:node1169
      assessable: false
      depth: 1
      name: 'ANNEX VII '
      description: Conformity based on an assessment of the quality management system
        and an assessment of the technical documentation
    - urn: urn:intuitem:risk:req_node:ai-act:node1170
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1169
      description: '1. Introduction

        Conformity based on an assessment of the quality management system and an
        assessment of the technical documentation is the conformity assessment procedure
        based on points 2 to 5.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1171
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1169
      description: '2. Overview

        The approved quality management system for the design, development and testing
        of AI systems pursuant to Article 17 shall be examined in accordance with
        point 3 and shall be subject to surveillance as specified in point 5. The
        technical documentation of the AI system shall be examined in accordance with
        point 4.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1172
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1169
      description: '3. Quality management system

        3.1. The application of the provider shall include:

        (a) the name and address of the provider and, if the application is lodged
        by an authorised representative, also their name and address;

        (b) the list of AI systems covered under the same quality management system;

        (c) the technical documentation for each AI system covered under the same
        quality management system;

        (d) the documentation concerning the quality management system which shall
        cover all the aspects listed under Article 17;

        (e) a description of the procedures in place to ensure that the quality management
        system remains adequate and effective;

        (f) a written declaration that the same application has not been lodged with
        any other notified body.

        3.2. The quality management system shall be assessed by the notified body,
        which shall determine whether it satisfies the requirements referred to in
        Article 17.

        The decision shall be notified to the provider or its authorised representative.

        3.4. Any intended change to the approved quality management system or the
        list of AI systems covered by the latter shall be brought to the attention
        of the notified body by the provider.

        The proposed changes shall be examined by the notified body, which shall decide
        whether the modified quality management system continues to satisfy the requirements
        referred to in point 3.2 or whether a reassessment is necessary.

        The notified body shall notify the provider of its decision. The notification
        shall contain the conclusions of the examination of the changes and the reasoned
        assessment decision.

        The notification shall contain the conclusions of the assessment of the quality
        management system and the reasoned assessment decision.

        3.3. The quality management system as approved shall continue to be implemented
        and maintained by the provider so that it remains adequate and efficient.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1173
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1169
      description: '4.Control of the technical documentation.

        4.1. In addition to the application referred to in point 3, an application
        with a notified body of their choice shall be lodged by the provider for the
        assessment of the technical documentation relating to the AI system which
        the provider intends to place on the market or put into service and which
        is covered by the quality management system referred to under point 3.

        4.2. The application shall include:

        (a) the name and address of the provider;

        (b) a written declaration that the same application has not been lodged with
        any other notified body;

        (c) the technical documentation referred to in Annex IV.

        4.3. The technical documentation shall be examined by the notified body. Where
        relevant and limited to what is necessary to fulfil its tasks, the notified
        body shall be granted full access to the training, validation, and testing
        data sets used, including, where appropriate and subject to security safeguards,
        through API or other relevant technical means and tools enabling remote access.

        4.4. In examining the technical documentation, the notified body may require
        that the provider supply further evidence or carry out further tests so as
        to enable a proper assessment of the conformity of the AI system with the
        requirements set out in Chapter III, Section 2. Where the notified body is
        not satisfied with the tests carried out by the provider, the notified body
        shall itself directly carry out adequate tests, as appropriate.

        4.5. Where necessary to assess the conformity of the high-risk AI system with
        the requirements set out in Chapter III, Section 2, after all other reasonable
        means to verify conformity have been exhausted and have proven to be insufficient,
        and upon a reasoned request, the notified body shall also be granted access
        to the training and trained models of the AI system, including its relevant
        parameters. Such access shall be subject to existing Union law on the protection
        of intellectual property and trade secrets.

        4.6. The decision of the notified body shall be notified to the provider or
        its authorised representative. The notification shall contain the conclusions
        of the assessment of the technical documentation and the reasoned assessment
        decision.

        Where the AI system is in conformity with the requirements set out in Chapter
        III, Section 2, the notified body shall issue a Union technical documentation
        assessment certificate. The certificate shall indicate the name and address
        of the provider, the conclusions of the examination, the conditions (if any)
        for its validity and the data necessary for the identification of the AI system.

        The certificate and its annexes shall contain all relevant information to
        allow the conformity of the AI system to be evaluated, and to allow for control
        of the AI system while in use, where applicable.

        Where the AI system is not in conformity with the requirements set out in
        Chapter III, Section 2, the notified body shall refuse to issue an Union technical
        documentation assessment certificate and shall inform the applicant accordingly,
        giving detailed reasons for its refusal.

        Where the AI system does not meet the requirement relating to the data used
        to train it, re- training of the AI system will be needed prior to the application
        for a new conformity assessment. In this case, the reasoned assessment decision
        of the notified body refusing to issue the Union technical documentation assessment
        certificate shall contain specific considerations on the quality data used
        to train the AI system, in particular on the reasons for non-compliance.

        4.7. Any change to the AI system that could affect the compliance of the AI
        system with the requirements or its intended purpose shall be assessed by
        the notified body which issued the Union technical documentation assessment
        certificate. The provider shall inform such notified body of its intention
        to introduce any of the abovementioned changes, or if it otherwise becomes
        aware of the occurrence of such changes. The intended changes shall be assessed
        by the notified body, which shall decide whether those changes require a new
        conformity assessment in accordance with Article 43(4) or whether they could
        be addressed by means of a supplement to the Union technical documentation
        assessment certificate. In the latter case, the notified body shall assess
        the changes, notify the provider of its decision and, where the changes are
        approved, issue to the provider a supplement to the Union technical documentation
        assessment certificate.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1174
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1169
      description: '5. Surveillance of the approved quality management system.

        5.1. The purpose of the surveillance carried out by the notified body referred
        to in Point 3 is to make sure that the provider duly abides by the terms and
        conditions of the approved quality management system.

        5.2. For assessment purposes, the provider shall allow the notified body to
        access the premises where the design, development, testing of the AI systems
        is taking place. The provider shall further share with the notified body all
        necessary information.

        5.3. The notified body shall carry out periodic audits to make sure that the
        provider maintains and applies the quality management system and shall provide
        the provider with an audit report. In the context of those audits, the notified
        body may carry out additional tests of the AI systems for which a Union technical
        documentation assessment certificate was issued.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1175
      assessable: false
      depth: 1
      name: ANNEX VIII
      description: Information to be submitted upon the registration of high-risk
        AI systems in accordance with Article 49
    - urn: urn:intuitem:risk:req_node:ai-act:node1176
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1175
      name: 'Section A '
      description: Information to be submitted by providers of high-risk AI systems
        in accordance with Article 49(1)
    - urn: urn:intuitem:risk:req_node:ai-act:node1177
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1176
      description: 'The following information shall be provided and thereafter kept
        up to date with regard to high-risk AI systems to be registered in accordance
        with Article 49(1):

        1. The name, address and contact details of the provider;

        2. Where submission of information is carried out by another person on behalf
        of the provider, the name, address and contact details of that person;

        3. The name, address and contact details of the authorised representative,
        where applicable;

        4. The AI system trade name and any additional unambiguous reference allowing
        the identification and traceability of the AI system;

        5. A description of the intended purpose of the AI system and of the components
        and functions supported through this AI system;

        6. A basic and concise description of the information used by the system (data,
        inputs) and its operating logic;

        7. The status of the AI system (on the market, or in service; no longer placed
        on the market/in service, recalled);

        8. The type, number and expiry date of the certificate issued by the notified
        body and the name or identification number of that notified body, where applicable;

        9. A scanned copy of the certificate referred to in point 8, where applicable;

        10. Any Member States in which the AI system was on the market, was put into
        service or made available in the Union;

        11. A copy of the EU declaration of conformity referred to in Article 47;

        12. Electronic instructions for use; this information shall not be provided
        for high-risk AI systems in the areas of law enforcement or migration, asylum
        and border control management referred to in Annex III, points 1, 6 and 7;

        13. A URL for additional information (optional).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1178
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1175
      name: 'Section B '
      description: Information to be submitted by providers of high-risk AI systems
        in accordance with Article 49(2)
    - urn: urn:intuitem:risk:req_node:ai-act:node1179
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1178
      description: 'The following information shall be provided and thereafter kept
        up to date with regard to AI systems to be registered in accordance with Article
        49(2):

        1. The name, address and contact details of the provider;

        2. Where submission of information is carried out by another person on behalf
        of the provider, the name, address and contact details of that person;

        3. The name, address and contact details of the authorised representative,
        where applicable;

        4. The AI system trade name and any additional unambiguous reference allowing
        the identification and traceability of the AI system;

        5. A description of the intended purpose of the AI system;

        6. The condition or conditions under in Article 6(3)based on which the AI
        system is considered to be not-high-risk;

        7. A short summary of the grounds on which the AI system is considered to
        be not-high- risk in application of the procedure under Article 6(3);

        8. The status of the AI system (on the market, or in service; no longer placed
        on the market/in service, recalled);

        9. Any Member States in which the AI system has been placed on the market,
        put into service or made available in the Union.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1180
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1175
      name: 'Section C '
      description: Information to be submitted by deployers of high-risk AI systems
        in accordance with Article 49(3)
    - urn: urn:intuitem:risk:req_node:ai-act:node1181
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1180
      description: 'The following information shall be provided and thereafter kept
        up to date with regard to high- risk AI systems to be registered in accordance
        with Article 49:

        1. The name, address and contact details of the deployer;

        2. The name, address and contact details of the person submitting information
        on behalf of the deployer;

        3. A summary of the findings of the fundamental rights impact assessment conducted
        in accordance with Article 27;

        4. The URL of the entry of the AI system in the EU database by its provider;

        5. A summary of the data protection impact assessment carried out in accordance
        with Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU)
        2016/680 as specified in Article 26(8) of this Regulation, where applicable.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1182
      assessable: false
      depth: 1
      name: 'ANNEX IX '
      description: Information to be submitted upon the registration of high-risk
        AI systems listed in Annex III in relation to testing in real world conditions
        in accordance with Article 60
    - urn: urn:intuitem:risk:req_node:ai-act:node1183
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1182
      description: 'The following information shall be provided and thereafter kept
        up to date with regard to testing in real world conditions to be registered
        in accordance with Article 60:

        1. A Union-wide unique single identification number of the testing in real
        world conditions;

        2. The name and contact details of the provider or prospective provider and
        of the deployers involved in the testing in real world conditions;

        3. A brief description of the AI system, its intended purpose, and other information
        necessary for the identification of the system;

        4. A summary of the main characteristics of the plan for testing in real world
        conditions;

        5. Information on the suspension or termination of the testing in real world
        conditions.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1184
      assessable: false
      depth: 1
      name: ANNEX X
      description: 'Union legislative acts on large-scale IT systems in the area of
        Freedom, Security and Justice '
    - urn: urn:intuitem:risk:req_node:ai-act:node1185
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '1.

        Union legislative acts on large-scale IT systems in the area of Freedom, Security
        and Justice

        Schengen Information System

        (a) Regulation (EU) 2018/1860 of the European Parliament and of the Council
        of

        28 November 2018 on the use of the Schengen Information System for the return
        of illegally staying third-country nationals (OJ L 312, 7.12.2018, p. 1).

        (b) Regulation (EU) 2018/1861 of the European Parliament and of the Council
        of

        28 November 2018 on the establishment, operation and use of the Schengen Information
        System (SIS) in the field of border checks, and amending the Convention implementing
        the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006
        (OJ L 312, 7.12.2018, p. 14)

        (c) Regulation (EU) 2018/1862 of the European Parliament and of the Council
        of

        28 November 2018 on the establishment, operation and use of the Schengen Information
        System (SIS) in the field of police cooperation and judicial cooperation in
        criminal matters, amending and repealing Council Decision 2007/533/JHA, and
        repealing Regulation (EC) No 1986/2006 of the European Parliament and of the
        Council and Commission Decision 2010/261/EU (OJ L 312, 7.12.2018, p. 56).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1186
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '2. Visa Information System

        (a) Regulation (EU) 2021/1133 of the European Parliament and of the Council
        of 7 July 2021 amending Regulations (EU) No 603/2013, (EU) 2016/794, (EU)
        2018/1862, (EU) 2019/816 and (EU) 2019/818 as regards the establishment of
        the conditions for accessing other EU information systems for the purposes
        of the Visa Information System (OJ L 248, 13.7.2021, p. 1).

        (b) Regulation (EU) 2021/1134 of the European Parliament and of the Council
        of 7 July 2021 amending Regulations (EC) No 767/2008, (EC) No 810/2009, (EU)
        2016/399, (EU) 2017/2226, (EU) 2018/1240, (EU) 2018/1860, (EU) 2018/1861,
        (EU) 2019/817 and (EU) 2019/1896 of the European Parliament and of the Council
        and repealing Council Decisions 2004/512/EC and 2008/633/JHA, for the purpose
        of reforming the Visa Information System (OJ L 248, 13.7.2021, p. 11).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1187
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: "3. Eurodac\nRegulation (EU) 2024/1358 of the European Parliament\
        \ and of the Council of 14 May 2024 on the establishment of \u2018Eurodac\u2019\
        \ for the comparison of biometric data in order to effectively apply Regulations\
        \ (EU) 2024/1315 and (EU) 2024/1350 of the European Parliament and of the\
        \ Council and Council Directive 2001/55/EC and to identify illegally staying\
        \ third-country nationals and stateless persons and on requests for the comparison\
        \ with Eurodac data by Member States\u2019 law enforcement authorities and\
        \ Europol for law enforcement purposes, amending Regulations (EU) 2018/1240\
        \ and (EU) 2019/818 of the European Parliament and of the Council and repealing\
        \ Regulation (EU) No 603/2013 of the European Parliament and of the Council\
        \ (OJ L, 2024/1358, 22.5.2024, ELI: http://data.europa.eu/eli/reg/2024/1358/oj)."
    - urn: urn:intuitem:risk:req_node:ai-act:node1188
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '4. Entry/Exit System

        (a) Regulation (EU) 2017/2226 of the European Parliament and of the Council
        of

        30 November 2017 establishing an Entry/Exit System (EES) to register entry
        and exit data and refusal of entry data of third-country nationals crossing
        the external borders of the Member States and determining the conditions for
        access to the EES for law enforcement purposes, and amending the Convention
        implementing the Schengen Agreement and Regulations (EC) No 767/2008 and (EU)
        No 1077/2011 (OJ L 327, 9.12.2017, p. 20).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1189
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '5. European Travel Information and Authorisation System

        (a) Regulation (EU) 2018/1240 of the European Parliament and of the Council
        of

        12 September 2018 establishing a European Travel Information and Authorisation
        System (ETIAS) and amending Regulations (EU) No 1077/2011, (EU) No 515/2014,
        (EU) 2016/399, (EU) 2016/1624 and (EU) 2017/2226 (OJ L 236, 19.9.2018, p.
        1).

        (b) Regulation (EU) 2018/1241 of the European Parliament and of the Council
        of 12 September 2018 amending Regulation (EU) 2016/794 for the purpose of
        establishing a European Travel Information and Authorisation System (ETIAS)
        (OJ L 236, 19.9.2018, p. 72).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1190
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '6. European Criminal Records Information System on third-country
        nationals and stateless persons

        (a) Regulation (EU) 2019/816 of the European Parliament and of the Council
        of

        17 April 2019 establishing a centralised system for the identification of
        Member States holding conviction information on third-country nationals and
        stateless persons (ECRIS-TCN) to supplement the European Criminal Records
        Information System and amending Regulation (EU) 2018/1726 (OJ L 135, 22.5.2019,
        p. 1).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1191
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1184
      description: '7. Interoperability

        (a) Regulation (EU) 2019/817 of the European Parliament and of the Council
        of

        20 May 2019 on establishing a framework for interoperability between EU information
        systems in the field of borders and visa (OJ L 135, 22.5.2019, p. 27).

        (b) Regulation (EU) 2019/818 of the European Parliament and of the Council
        of 20 May 2019 on establishing a framework for interoperability between EU
        information systems in the field of police and judicial cooperation, asylum
        and migration

        (OJ L 135, 22.5.2019, p. 85).'
    - urn: urn:intuitem:risk:req_node:ai-act:node1192
      assessable: false
      depth: 1
      name: 'ANNEX XI '
      description: Technical documentation referred to in Article 53(1), point (a)
        - technical documentation for providers of general-purpose AI models
    - urn: urn:intuitem:risk:req_node:ai-act:node1193
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1192
      name: Section 1
      description: Information to be provided by all providers of general-purpose
        AI models
    - urn: urn:intuitem:risk:req_node:ai-act:node1194
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1193
      description: 'The technical documentation referred to in Article 53(1), point
        (a) shall contain at least the following information as appropriate to the
        size and risk profile of the model:

        1. A general description of the general-purpose AI model including:

        (a) the tasks that the model is intended to perform and the type and nature
        of AI systems in which it can be integrated;

        (b) the acceptable use policies applicable;

        (c) the date of release and methods of distribution;

        (d) the architecture and number of parameters;

        (e) the modality (e.g. text, image) and format of inputs and outputs;

        (f) the licence.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1195
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1193
      description: "2. A detailed description of the elements of the model referred\
        \ to in point 1, and relevant information of the process for the development,\
        \ including the following elements:\n(a) the technical means (e.g. instructions\
        \ of use, infrastructure, tools) required for the general-purpose AI model\
        \ to be integrated in AI systems;\n(b) the design specifications of the model\
        \ and training process, including training methodologies and techniques, the\
        \ key design choices including the rationale and assumptions made; what the\
        \ model is designed to optimise for and the relevance of the different parameters,\
        \ as applicable;\n(c) information on the data used for training, testing and\
        \ validation, where applicable, including the type and provenance of data\
        \ and curation methodologies (e.g. cleaning, filtering etc), the number of\
        \ data points, their scope and main characteristics; how the data was obtained\
        \ and selected as well as all other measures to detect the unsuitability of\
        \ data sources and methods to detect identifiable biases, where applicable;\n\
        (d) the computational resources used to train the model (e.g. number of floating\
        \ point operations \u2013 FLOPs-), training time, and other relevant details\
        \ related to the training;\n(e) known or estimated energy consumption of the\
        \ model.\nWith regard to point (e), where the energy consumption of the model\
        \ is unknown, the energy consumption may be based on information about computational\
        \ resources used."
    - urn: urn:intuitem:risk:req_node:ai-act:node1196
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1192
      name: Section 2
      description: Additional information to be provided by providers of general-purpose
        AI models with systemic risk
    - urn: urn:intuitem:risk:req_node:ai-act:node1197
      assessable: false
      depth: 3
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1196
      description: '1. A detailed description of the evaluation strategies, including
        evaluation results, on the basis of available public evaluation protocols
        and tools or otherwise of other evaluation methodologies. Evaluation strategies
        shall include evaluation criteria, metrics and the methodology on the identification
        of limitations.

        2. Where applicable, a detailed description of the measures put in place for
        the purpose of conducting internal and/or external adversarial testing (e.g.,
        red teaming), model adaptations, including alignment and fine-tuning.

        3. Where applicable, a detailed description of the system architecture explaining
        how software components build or feed into each other and integrate into the
        overall processing.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1198
      assessable: false
      depth: 1
      name: 'ANNEX XII '
      description: 'Transparency information referred to in Article 53(1), point (b)

        - technical documentation for providers of general-purpose AI models to downstream
        providers that integrate the model into their AI system'
    - urn: urn:intuitem:risk:req_node:ai-act:node1199
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1198
      description: 'The information referred to in Article 53(1), point (b) shall
        contain at least the following: 1. A general description of the general-purpose
        AI model including:

        (a) the tasks that the model is intended to perform and the type and nature
        of AI systems into which it can be integrated;

        (b) the acceptable use policies applicable;

        (c) the date of release and methods of distribution;

        (d) how the model interacts, or can be used to interact, with hardware or
        software that is not part of the model itself, where applicable;

        (e) the versions of relevant software related to the use of the general-purpose
        AI model, where applicable;

        (f) the architecture and number of parameters;

        (g) the modality (e.g., text, image) and format of inputs and outputs;

        (h) the licence for the model.

        2. A description of the elements of the model and of the process for its development,
        including:

        (a) the technical means (e.g., instructions for use, infrastructure, tools)
        required for the general-purpose AI model to be integrated into AI systems;

        (b) the modality (e.g., text, image, etc.) and format of the inputs and outputs
        and their maximum size (e.g., context window length, etc.);

        (c) information on the data used for training, testing and validation, where
        applicable, including the type and provenance of data and curation methodologies.'
    - urn: urn:intuitem:risk:req_node:ai-act:node1200
      assessable: false
      depth: 1
      name: 'ANNEX XIII '
      description: Criteria for the designation of general-purpose AI models with
        systemic risk referred to in Article 51
    - urn: urn:intuitem:risk:req_node:ai-act:node1201
      assessable: false
      depth: 2
      parent_urn: urn:intuitem:risk:req_node:ai-act:node1200
      description: 'For the purpose of determining that a general-purpose AI model
        has capabilities or an impact equivalent to those set out in Article 51(1),
        points (a) and (b), the Commission shall take into account the following criteria:

        (a) the number of parameters of the model;

        (b) the quality or size of the data set, for example measured through tokens;

        (c) the amount of computation used for training the model, measured in FLOPs
        or indicated by a combination of other variables such as estimated cost of
        training, estimated time required for the training, or estimated energy consumption
        for the training;

        (d) the input and output modalities of the model, such as text to text (large
        language models), text to image, multi-modality, and the state-of-the-art
        thresholds for determining high-impact capabilities for each modality, and
        the specific type of inputs and outputs (e.g. biological sequences);

        (e) the benchmarks and evaluations of capabilities of the model, including
        considering the number of tasks without additional training, adaptability
        to learn new, distinct tasks, its degree of autonomy and scalability, the
        tools it has access to;

        (f) whether it has a high impact on the internal market due to its reach,
        which shall be presumed when it has been made available to at least 10 000
        registered business users established in the Union;

        (g) the number of registered end-users.'
