EU AI Act · Regulation (EU) 2024/1689
AI Act compliance for health AI: what TEF-Health offers
The EU AI Act sets binding requirements for AI systems used in health and medical settings — from risk management and data governance to human oversight and conformity assessment. TEF-Health helps developers and providers of medical AI test, validate and document their systems against these obligations across the full AI lifecycle. Explore the Act article by article below, and see where our services support compliance.
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Art. 1 Subject matter
1. 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,
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Art. 2 Scope
1. 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)
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Art. 3 Definitions
For the purposes of this Regulation, the following definitions apply: (1) ‘AI system’ means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives,
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Art. 4 AI literacy 2 TEF services
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,
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Art. 5 Prohibited AI practices
1. The following AI practices shall be prohibited: (a) the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or
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Art. 6 Classification rules for high-risk AI systems
1. Irrespective of whether an AI system is placed on the market or put into service independently of 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: (a) the AI system is
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Art. 7 Amendments to Annex III
1. The Commission is empowered to 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
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Art. 8 Compliance with the requirements
1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose 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
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Art. 9 Risk management system 121 TEF services
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems. 2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI
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Art. 10 Data and data governance 103 TEF services
1. 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. 2.
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Art. 11 Technical documentation 31 TEF services
1. 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
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Art. 12 Record-keeping 1 TEF service
1. High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system. 2. 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,
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Art. 13 Transparency and provision of information to deployers 10 TEF services
1. 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’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a
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Art. 14 Human oversight 30 TEF services
1. 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. 2. Human oversight shall aim to prevent or
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Art. 15 Accuracy, robustness and cybersecurity 124 TEF services
1. 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. 2. To address the technical aspects of how to
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Art. 16 Obligations of providers of high-risk AI systems 2 TEF services
Providers of high-risk AI systems shall: (a) ensure that their high-risk AI systems are compliant with the requirements set out in Section 2; (b) indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as
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Art. 17 Quality management system 11 TEF services
1. 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
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Art. 18 Documentation keeping 2 TEF services
1. 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: (a) the technical documentation referred to in Article 11; (b) the documentation
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Art. 19 Automatically generated logs
1. 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
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Art. 20 Corrective actions and duty of information 1 TEF service
1. 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
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Art. 21 Cooperation with competent authorities 2 TEF services
1. 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
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Art. 22 Authorised representatives of providers of high-risk AI systems
1. 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. 2. The provider shall enable its authorised representative to
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Art. 23 Obligations of importers
1. 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: (a) the relevant conformity assessment procedure referred to in Article 43 has been carried out by the provider of the high-risk
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Art. 24 Obligations of distributors
1. 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 the EU declaration of conformity referred to in Article 47 and instructions for use, and that the provider and the
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Art. 25 Responsibilities along the AI value chain
1. 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: (a) they
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Art. 26 Obligations of deployers of high-risk AI systems 1 TEF service
1. 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. 2. Deployers shall assign human oversight to
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Art. 27 Fundamental rights impact assessment for high-risk AI systems 2 TEF services
1. Prior to deploying a high-risk AI system referred to in Article 6(2), 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
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Art. 28 Notifying authorities
1. 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
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Art. 29 Application of a conformity assessment body for notification
1. Conformity assessment bodies shall submit an application for notification to the notifying authority of the Member State in which they are established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, the
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Art. 30 Notification procedure
1. Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 31. 2. Notifying authorities shall notify the Commission and the other Member States, using the electronic notification tool developed and managed by
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Art. 31 Requirements relating to notified bodies
1. A notified body shall be established under the national law of a Member State and shall have legal personality. 2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as
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Art. 32 Presumption of conformity with requirements relating to notified bodies
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
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Art. 33 Subsidiaries of notified bodies and subcontracting
1. 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
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Art. 34 Operational obligations of notified bodies
1. Notified bodies shall verify the conformity of high-risk AI systems in accordance with the conformity assessment procedures set out in Article 43. 2. Notified bodies shall avoid unnecessary burdens for providers when performing their activities, and take due account of the
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Art. 35 Identification numbers and lists of notified bodies
1. The Commission shall assign a single identification number to each notified body, even where a body is notified under more than one Union act. 2. The Commission shall make publicly available the list of the bodies notified under this Regulation, including their identification
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Art. 36 Changes to notifications
1. 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). 2. The procedures laid down in Articles 29 and 30 shall apply to
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Art. 37 Challenge to the competence of notified bodies
1. 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. 2. The notifying
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Art. 38 Coordination of notified bodies
1. 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
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Art. 39 Conformity assessment bodies of third countries
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 laid down in Article 31 or
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Art. 40 Harmonised standards and standardisation deliverables
1. High-risk AI systems or general-purpose AI models 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
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Art. 41 Common specifications
1. The Commission may 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 Sections 2 and 3 of Chapter V where the following conditions have been fulfilled: (a) the
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Art. 42 Presumption of conformity with certain requirements
1. 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 comply with the relevant requirements laid down in Article 10(4).
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Art. 43 Conformity assessment 39 TEF services
1. 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
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Art. 44 Certificates
1. 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. 2. Certificates shall be valid for the period they
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Art. 45 Information obligations of notified bodies
1. 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;
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Art. 46 Derogation from conformity assessment procedure
1. 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
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Art. 47 EU declaration of conformity 1 TEF service
1. 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
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Art. 48 CE marking
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. 2. 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
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Art. 49 Registration
1. 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
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Art. 50 Transparency obligations for providers and deployers of certain AI systems 1 TEF service
1. 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
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Art. 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk
1. A general-purpose AI model shall be classified as a general-purpose AI model with systemic risk if it meets any of the following conditions: (a) it has high impact capabilities evaluated on the basis of appropriate technical tools and methodologies, including indicators and
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Art. 52 Procedure
1. Where a general-purpose AI model meets the condition 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
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Art. 53 Obligations for providers of general-purpose AI models
1. Providers of general-purpose AI models shall: (a) 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 information set out in Annex XI for the
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Art. 54 Authorised representatives of providers of general-purpose AI models
1. 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. 2. The provider shall enable its authorised representative to perform
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Art. 55 Obligations of providers of general-purpose AI models with systemic risk
1. In addition to the obligations listed in Articles 53 and 54, providers of general-purpose AI models with systemic risk shall: (a) perform model evaluation in accordance with standardised protocols and tools reflecting the state of the art, including conducting and documenting
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Art. 56 Codes of practice
1. 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. 2. The AI Office and the Board shall aim to ensure that the codes
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Art. 57 AI regulatory sandboxes
1. 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
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Art. 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes
1. 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
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Art. 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox 1. In the AI regulatory sandbox, personal data lawfully collected for other purposes may be processed solely for the purpose of developing, training and
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Art. 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes 39 TEF services
1. 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
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Art. 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes 10 TEF services
1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be 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
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Art. 62 Measures for providers and deployers, in particular SMEs, including start-ups
1. 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
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Art. 63 Derogations for specific operators
1. 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
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Art. 64 AI Office
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office. 2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this
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Art. 65 Establishment and structure of the European Artificial Intelligence Board
1. A European Artificial Intelligence Board (the ‘Board’) is hereby established. 2. 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’s meetings,
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Art. 66 Tasks of the Board
The Board shall advise and assist the Commission and the Member States in order to facilitate the consistent and effective application of this Regulation. To that end, the Board may in particular: (a) contribute to the coordination among national competent authorities
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Art. 67 Advisory forum
1. 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. 2. The membership of the advisory forum shall represent a balanced selection of stakeholders, including
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Art. 68 Scientific panel of independent experts
1. The Commission shall, by means of an implementing act, make provisions on the establishment of a scientific panel of independent experts (the ‘scientific panel’) intended to support the enforcement activities under this Regulation. That implementing act shall be adopted in
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Art. 69 Access to the pool of experts by the Member States
1. Member States may call upon experts of the scientific panel to support their enforcement activities under this Regulation. 2. 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
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Art. 70 Designation of national competent authorities and single points of contact
1. 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
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Art. 71 EU database for high-risk AI systems listed in Annex III
1. 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
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Art. 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems 9 TEF services
1. 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. 2. The post-market monitoring system shall actively and systematically collect, document and
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Art. 73 Reporting of serious incidents 4 TEF services
1. 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. 2. The report referred to in paragraph 1 shall be made immediately after the provider has
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Art. 74 Market surveillance and control of AI systems in the Union market
1. 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
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Art. 75 Mutual assistance, market surveillance and control of general-purpose AI systems
1. 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
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Art. 76 Supervision of testing in real world conditions by market surveillance authorities
1. Market surveillance authorities shall have competences and powers to ensure that testing in real world conditions is in accordance with this Regulation. 2. Where testing in real world conditions is conducted for AI systems that are supervised within an AI regulatory sandbox
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Art. 77 Powers of authorities protecting fundamental rights
1. 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
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Art. 78 Confidentiality
1. 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 or national law, respect the confidentiality of information and data obtained in carrying
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Art. 79 Procedure at national level for dealing with AI systems presenting a risk
1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ 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. 2. Where the market surveillance
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Art. 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
1. Where a market surveillance authority has sufficient reason to consider that an AI system classified by the provider as non-high-risk pursuant to Article 6(3) is indeed high-risk, the market surveillance authority shall carry out an evaluation of the AI system concerned in
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Art. 81 Union safeguard procedure
1. 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
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Art. 82 Compliant AI systems which present a risk
1. 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 complies with this Regulation, it
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Art. 83 Formal non-compliance
1. 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) the CE marking has been affixed in violation of Article
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Art. 84 Union AI testing support structures
1. 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. 2. Without prejudice to the tasks referred to in paragraph 1, Union AI testing support structures
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Art. 85 Right to lodge a complaint with a market surveillance authority
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 complaints to the relevant market surveillance authority. In accordance with
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Art. 86 Right to explanation of individual decision-making
1. 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
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Art. 87 Reporting of infringements and protection of reporting persons
Directive (EU) 2019/1937 shall apply to the reporting of infringements of this Regulation and the protection of persons reporting such infringements. SECTION 5 Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI
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Art. 88 Enforcement of the obligations of providers of general-purpose AI models
1. 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
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Art. 89 Monitoring actions
1. 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
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Art. 90 Alerts of systemic risks by the scientific panel
1. 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 conditions referred to in Article 51. 2. Upon
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Art. 91 Power to request documentation and information
1. The Commission may request the provider of the general-purpose AI model concerned to provide the documentation drawn up by the provider in accordance with Articles 53 and 55, or any additional information that is necessary for the purpose of assessing compliance of the
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Art. 92 Power to conduct evaluations
1. 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
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Art. 93 Power to request measures
1. Where necessary and appropriate, the Commission may request providers to: (a) take appropriate measures to comply with the obligations set out in Articles 53 and 54; (b) implement mitigation measures, where the evaluation carried out in accordance with Article 92 has given
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Art. 94 Procedural rights of economic operators of the general-purpose AI model
# 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. *CHAPTER IX · POST-MARKET MONITORING, INFORMATION SHARING AND MARKET
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Art. 95 Codes of conduct for voluntary application of specific requirements
1. 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
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Art. 96 Guidelines from the Commission on the implementation of this Regulation
1. 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;
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Art. 97 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. 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
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Art. 98 Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall
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Art. 99 Penalties
1. In accordance 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
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Art. 100 Administrative fines on Union institutions, bodies, offices and agencies
1. 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
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Art. 101 Fines for providers of general-purpose AI models
1. The Commission may impose on providers of general-purpose AI models fines not exceeding 3 % of their annual total worldwide turnover in the preceding financial year or EUR 15 000 000, whichever is higher., when the Commission finds that the provider intentionally or
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Art. 102 Amendment to Regulation (EC) No 300/2008
In Article 4(3) of Regulation (EC) No 300/2008, the following subparagraph is added: ‘When adopting detailed measures related to technical specifications and procedures for approval and use of security equipment concerning Artificial Intelligence systems within the meaning of
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Art. 103 Amendment to Regulation (EU) No 167/2013
In Article 17(5) of Regulation (EU) No 167/2013, the following subparagraph is added: ‘When 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
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Art. 104 Amendment to Regulation (EU) No 168/2013
In Article 22(5) of Regulation (EU) No 168/2013, the following subparagraph is added: ‘When 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
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Art. 105 Amendment to Directive 2014/90/EU
In Article 8 of Directive 2014/90/EU, the following paragraph is added: ‘5. 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
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Art. 106 Amendment to Directive (EU) 2016/797
In Article 5 of Directive (EU) 2016/797, the following paragraph is added: ‘12. 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
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Art. 107 Amendment to Regulation (EU) 2018/858
In Article 5 of Regulation (EU) 2018/858 the following paragraph is added: ‘4. 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
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Art. 108 Amendments to Regulation (EU) 2018/1139
Regulation (EU) 2018/1139 is amended as follows: (1) in Article 17, the following paragraph is added: ‘3. Without prejudice to paragraph 2, when adopting implementing acts pursuant to paragraph 1 concerning Artificial Intelligence systems which are safety components within the
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Art. 109 Amendment to Regulation (EU) 2019/2144
In Article 11 of Regulation (EU) 2019/2144, the following paragraph is added: ‘3. 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
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Art. 110 Amendment to Directive (EU) 2020/1828
In Annex I to Directive (EU) 2020/1828 of the European Parliament and of the Council ( 58 ) , the following point is added: ‘(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
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Art. 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
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
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Art. 112 Evaluation and review
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
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Art. 113 Entry into force and application
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) **(c)** # Article 6(1) and the
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