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AI Act

Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence
32024R1689 · official text on EUR-Lex

Articles

Chapter I GENERAL PROVISIONS

• Article 1 — Subject matter`
• Article 2 — Scope
• Article 3 — Definitions
• Article 4 — AI literacy

Chapter II PROHIBITED AI PRACTICES

• Article 5 — Prohibited AI practices

Chapter III HIGH-RISK AI SYSTEMS

Section 1 Classification of AI systems as high-risk

• Article 6 — Classification rules for high-risk AI systems
• Article 7 — Amendments to Annex III

Section 2 Requirements for high-risk AI systems

• Article 8 — Compliance with the requirements
• Article 9 — Risk management system
• Article 10 — Data and data governance
• Article 11 — Technical documentation
• Article 12 — Record-keeping
• Article 13 — Transparency and provision of information to deployers
• Article 14 — Human oversight
• Article 15 — Accuracy, robustness and cybersecurity

Section 3 Obligations of providers and deployers of high-risk AI systems and other parties

• Article 16 — Obligations of providers of high-risk AI systems
• Article 17 — Quality management system
• Article 18 — Documentation keeping
• Article 19 — Automatically generated logs
• Article 20 — Corrective actions and duty of information
• Article 21 — Cooperation with competent authorities
• Article 22 — Authorised representatives of providers of high-risk AI systems
• Article 23 — Obligations of importers
• Article 24 — Obligations of distributors
• Article 25 — Responsibilities along the AI value chain
• Article 26 — Obligations of deployers of high-risk AI systems
• Article 27 — Fundamental rights impact assessment for high-risk AI systems

Section 4 Notifying authorities and notified bodies

• Article 28 — Notifying authorities
• Article 29 — Application of a conformity assessment body for notification
• Article 30 — Notification procedure
• Article 31 — Requirements relating to notified bodies
• Article 32 — Presumption of conformity with requirements relating to notified bodies
• Article 33 — Subsidiaries of notified bodies and subcontracting
• Article 34 — Operational obligations of notified bodies
• Article 35 — Identification numbers and lists of notified bodies
• Article 36 — Changes to notifications
• Article 37 — Challenge to the competence of notified bodies
• Article 38 — Coordination of notified bodies
• Article 39 — Conformity assessment bodies of third countries

Section 5 Standards, conformity assessment, certificates, registration

• Article 40 — Harmonised standards and standardisation deliverables
• Article 41 — Common specifications
• Article 42 — Presumption of conformity with certain requirements
• Article 43 — Conformity assessment
• Article 44 — Certificates
• Article 45 — Information obligations of notified bodies
• Article 46 — Derogation from conformity assessment procedure
• Article 47 — EU declaration of conformity
• Article 48 — CE marking
• Article 49 — Registration

Chapter IV TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS

• Article 50 — Transparency obligations for providers and deployers of certain AI systems

Chapter V GENERAL-PURPOSE AI MODELS

Section 1 Classification rules

• Article 51 — Classification of general-purpose AI models as general-purpose AI models with systemic risk
• Article 52 — Procedure

Section 2 Obligations for providers of general-purpose AI models

• Article 53 — Obligations for providers of general-purpose AI models
• Article 54 — Authorised representatives of providers of general-purpose AI models

Section 3 Obligations of providers of general-purpose AI models with systemic risk

• Article 55 — Obligations of providers of general-purpose AI models with systemic risk

Section 4 Codes of practice

• Article 56 — Codes of practice

Chapter VI MEASURES IN SUPPORT OF INNOVATION

• Article 57 — AI regulatory sandboxes
• Article 58 — Detailed arrangements for, and functioning of, AI regulatory sandboxes
• Article 59 — Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
• Article 60 — Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
• Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
• Article 62 — Measures for providers and deployers, in particular SMEs, including start-ups
• Article 63 — Derogations for specific operators

Chapter VII GOVERNANCE

Section 1 Governance at Union level

• Article 64 — AI Office
• Article 65 — Establishment and structure of the European Artificial Intelligence Board
• Article 66 — Tasks of the Board
• Article 67 — Advisory forum
• Article 68 — Scientific panel of independent experts
• Article 69 — Access to the pool of experts by the Member States

Section 2 National competent authorities

• Article 70 — Designation of national competent authorities and single points of contact

Chapter VIII EU DATABASE FOR HIGH-RISK AI SYSTEMS

• Article 71 — EU database for high-risk AI systems listed in Annex III

Chapter IX POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE

Section 1 Post-market monitoring

• Article 72 — Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems

Section 2 Sharing of information on serious incidents

• Article 73 — Reporting of serious incidents

Section 3 Enforcement

• Article 74 — Market surveillance and control of AI systems in the Union market
• Article 75 — Mutual assistance, market surveillance and control of general-purpose AI systems
• Article 76 — Supervision of testing in real world conditions by market surveillance authorities
• Article 77 — Powers of authorities protecting fundamental rights
• Article 78 — Confidentiality
• Article 79 — Procedure at national level for dealing with AI systems presenting a risk
• Article 80 — Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
• Article 81 — Union safeguard procedure
• Article 82 — Compliant AI systems which present a risk
• Article 83 — Formal non-compliance
• Article 84 — Union AI testing support structures

Section 4 Remedies

• Article 85 — Right to lodge a complaint with a market surveillance authority
• Article 86 — Right to explanation of individual decision-making
• Article 87 — Reporting of infringements and protection of reporting persons

Section 5 Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models

• Article 88 — Enforcement of the obligations of providers of general-purpose AI models
• Article 89 — Monitoring actions
• Article 90 — Alerts of systemic risks by the scientific panel
• Article 91 — Power to request documentation and information
• Article 92 — Power to conduct evaluations
• Article 93 — Power to request measures
• Article 94 — Procedural rights of economic operators of the general-purpose AI model

Chapter X CODES OF CONDUCT AND GUIDELINES

• Article 95 — Codes of conduct for voluntary application of specific requirements
• Article 96 — Guidelines from the Commission on the implementation of this Regulation

Chapter XI DELEGATION OF POWER AND COMMITTEE PROCEDURE

• Article 97 — Exercise of the delegation
• Article 98 — Committee procedure

Chapter XII PENALTIES

• Article 99 — Penalties
• Article 100 — Administrative fines on Union institutions, bodies, offices and agencies
• Article 101 — Fines for providers of general-purpose AI models

Chapter XIII FINAL PROVISIONS

• Article 102 — Amendment to Regulation (EC) No 300/2008
• Article 103 — Amendment to Regulation (EU) No 167/2013
• Article 104 — Amendment to Regulation (EU) No 168/2013
• Article 105 — Amendment to Directive 2014/90/EU
• Article 106 — Amendment to Directive (EU) 2016/797
• Article 107 — Amendment to Regulation (EU) 2018/858
• Article 108 — Amendments to Regulation (EU) 2018/1139
• Article 109 — Amendment to Regulation (EU) 2019/2144
• Article 110 — Amendment to Directive (EU) 2020/1828
• Article 111 — AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
• Article 112 — Evaluation and review
• Article 113 — Entry into force and application