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| | Recitals |
| | Chapter I General provisions (arts. 1-4) |
Entered into force | Article 1 Subject matter |
Entered into force | Article 2 Scope |
Entered into force | Article 3 Definitions |
Entered into force | Article 4 AI literacy |
| | Chapter II Prohibited AI practices (art. 5) |
Entered into force | Article 5 Prohibited AI practices |
| | Chapter III High-risk AI systems (arts. 6-49) |
| | Section 1 Classification of AI systems as high-risk (arts. 6-7) |
Entered into force | Article 6 Classification rules for high-risk AI systems |
Entered into force | Article 7 Amendments to Annex III |
| | Section 2 Requirements for high-risk AI systems (arts. 8-15) |
Entered into force | Article 8 Compliance with the requirements |
Entered into force | Article 9 Risk management system |
Entered into force | Article 10 Data and data governance |
Entered into force | Article 11 Technical documentation |
Entered into force | Article 12 Record-keeping |
Entered into force | Article 13 Transparency and provision of information to deployers |
Entered into force | Article 14 Human oversight |
Entered into force | Article 15 Accuracy, robustness and cybersecurity |
| | Section 3 Obligations of providers and deployers of high-risk AI systems and other parties (arts. 16-27) |
Entered into force | Article 16 Obligations of providers of high-risk AI systems |
Entered into force | Article 17 Quality management system |
Entered into force | Article 18 Documentation keeping |
Entered into force | Article 19 Automatically generated logs |
Entered into force | Article 20 Corrective actions and duty of information |
Entered into force | Article 21 Cooperation with competent authorities |
Entered into force | Article 22 Authorised representatives of providers of high-risk AI systems |
Entered into force | Article 23 Obligations of importers |
Entered into force | Article 24 Obligations of distributors |
Entered into force | Article 25 Responsibilities along the AI value chain |
Entered into force | Article 26 Obligations of deployers of high-risk AI systems |
Entered into force | Article 27 Fundamental rights impact assessment for high-risk AI systems |
| | Section 4 Notifying authorities and notified bodies (arts. 28-39) |
Entered into force | Article 28 Notifying authorities |
Entered into force | Article 29 Application of a conformity assessment body for notification |
Entered into force | Article 30 Notification procedure |
Entered into force | Article 31 Requirements relating to notified bodies |
Entered into force | Article 32 Presumption of conformity with requirements relating to notified bodies |
Entered into force | Article 33 Subsidiaries of notified bodies and subcontracting |
Entered into force | Article 34 Operational obligations of notified bodies |
Entered into force | Article 35 Identification numbers and lists of notified bodies |
Entered into force | Article 36 Changes to notifications |
Entered into force | Article 37 Challenge to the competence of notified bodies |
Entered into force | Article 38 Coordination of notified bodies |
Entered into force | Article 39 Conformity assessment bodies of third countries |
| | Section 5 Standards, conformity assessment, certificates, registration (arts. 40-49) |
Entered into force | Article 40 Harmonised standards and standardisation deliverables |
Entered into force | Article 41 Common specifications |
Entered into force | Article 42 Presumption of conformity with certain requirements |
Entered into force | Article 43 Conformity assessment |
Entered into force | Article 44 Certificates |
Entered into force | Article 45 Information obligations of notified bodies |
Entered into force | Article 46 Derogation from conformity assessment procedure |
Entered into force | Article 47 EU declaration of conformity |
Entered into force | Article 48 CE marking |
Entered into force | Article 49 Registration |
| | Chapter IV Transparency obligations for providers and deployers of certain AI systems (art. 50) |
Entered into force | Article 50 Transparency obligations for providers and deployers of certain AI systems |
| | Chapter V General-purpose AI models (arts. 51-56) |
| | Section 1 Classification rules (arts. 51-52) |
Entered into force | Article 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk |
Entered into force | Article 52 Procedure |
| | Section 2 Obligations for providers of general-purpose AI models (arts. 53-54) |
Entered into force | Article 53 Obligations for providers of general-purpose AI models |
Entered into force | Article 54 Authorised representatives of providers of general-purpose AI models |
| | Section 3 Obligations of providers of general-purpose AI models with systemic risk (art. 55) |
Entered into force | Article 55 Obligations of providers of general-purpose AI models with systemic risk |
| | Section 4 Codes of practice (art. 56) |
Entered into force | Article 56 Codes of practice |
| | Chapter VI Measures in support of innovation (arts. 57-63) |
Entered into force | Article 57 AI regulatory sandboxes |
Entered into force | Article 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes |
Entered into force | Article 59 Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox |
Entered into force | Article 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes |
Entered into force | Article 61 Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes |
Entered into force | Article 62 Measures for providers and deployers, in particular SMEs, including start-ups |
Entered into force | Article 63 Derogations for specific operators |
| | Chapter VII Governance (arts. 64-70) |
| | Section 1 Governance at Union level (arts. 64-69) |
Entered into force | Article 64 AI Office |
Entered into force | Article 65 Establishment and structure of the European Artificial Intelligence Board |
Entered into force | Article 66 Tasks of the Board |
Entered into force | Article 67 Advisory forum |
Entered into force | Article 68 Scientific panel of independent experts |
Entered into force | Article 69 Access to the pool of experts by the Member States |
| | Section 2 National competent authorities (art. 70) |
Entered into force | Article 70 Designation of national competent authorities and single points of contact |
| | Chapter VIII EU database for high-risk AI systems (art. 71) |
Entered into force | Article 71 EU database for high-risk AI systems listed in Annex III |
| | Chapter IX Post-market monitoring, information sharing and market surveillance (arts. 72-94) |
| | Section 1 Post-market monitoring (art. 72) |
Entered into force | 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 (art. 73) |
Entered into force | Article 73 Reporting of serious incidents |
| | Section 3 Enforcement (arts. 74-84) |
Entered into force | Article 74 Market surveillance and control of AI systems in the Union market |
Entered into force | Article 75 Mutual assistance, market surveillance and control of general-purpose AI systems |
Entered into force | Article 76 Supervision of testing in real world conditions by market surveillance authorities |
Entered into force | Article 77 Powers of authorities protecting fundamental rights |
Entered into force | Article 78 Confidentiality |
Entered into force | Article 79 Procedure at national level for dealing with AI systems presenting a risk |
Entered into force | Article 80 Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III |
Entered into force | Article 81 Union safeguard procedure |
Entered into force | Article 82 Compliant AI systems which present a risk |
Entered into force | Article 83 Formal non-compliance |
Entered into force | Article 84 Union AI testing support structures |
| | Section 4 Remedies (arts. 85-87) |
Entered into force | Article 85 Right to lodge a complaint with a market surveillance authority |
Entered into force | Article 86 Right to explanation of individual decision-making |
Entered into force | 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 (art. 88-94) |
Entered into force | Article 88 Enforcement of the obligations of providers of general-purpose AI models |
Entered into force | Article 89 Monitoring actions |
Entered into force | Article 90 Alerts of systemic risks by the scientific panel |
Entered into force | Article 91 Power to request documentation and information |
Entered into force | Article 92 Power to conduct evaluations |
Entered into force | Article 93 Power to request measures |
Entered into force | Article 94 Procedural rights of economic operators of the general-purpose AI model |
| | Chapter X Codes of conduct and guidelines (arts. 95-96) |
Entered into force | Article 95 Codes of conduct for voluntary application of specific requirements |
Entered into force | Article 96 Guidelines from the Commission on the implementation of this Regulation |
| | Chapter XI Delegation of power and committee procedure (arts. 97-98) |
Entered into force | Article 97 Exercise of the delegation |
Entered into force | Article 98 Committee procedure |
| | Chapter XII Penalties (arts. 99-101) |
Entered into force | Article 99 Penalties |
Entered into force | Article 100 Administrative fines on Union institutions, bodies, offices and agencies |
Entered into force | Article 101 Fines for providers of general-purpose AI models |
| | Chapter XIII Final Provisions (arts. 102-113) |
Entered into force | Article 102 Amendment to Regulation (EC) No 300/2008 |
Entered into force | Article 103 Amendment to Regulation (EU) No 167/2013 |
Entered into force | Article 104 Amendment to Regulation (EU) No 168/2013 |
Entered into force | Article 105 Amendment to Directive 2014/90/EU |
Entered into force | Article 106 Amendment to Directive (EU) 2016/797 |
Entered into force | Article 107 Amendment to Regulation (EU) 2018/858 |
Entered into force | Article 108 Amendments to Regulation (EU) 2018/1139 |
Entered into force | Article 109 Amendment to Regulation (EU) 2019/2144 |
Entered into force | Article 110 Amendment to Directive (EU) 2020/1828 |
Entered into force | Article 111 AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked |
Entered into force | Article 112 Evaluation and review |
Entered into force | Article 113 Entry into force and application |
Entered into force | Annex I |
Entered into force | Annex II List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii) |
Entered into force | Annex III High-risk AI systems referred to in Article 6(2) |
Entered into force | Annex IV Technical documentation referred to in Article 11(1) |
Entered into force | Annex V EU declaration of conformity |
Entered into force | Annex VI Conformity assessment procedure based on internal control |
Entered into force | Annex VII |
Entered into force | Annex VIII Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49 |
Entered into force | Annex IX 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 |
Entered into force | Annex X Union legislative acts on large-scale IT systems in the area of Freedom, Security and Justice |
Entered into force | Annex XI Technical documentation referred to in Article 53(1), point (a) - technical documentation for providers of general-purpose AI models |
Entered into force | Annex XII 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 |
Entered into force | Annex XIII Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51 |
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