Regulation (EU) 2024/1689
Artificial Intelligence Act
Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence
In force since August 1, 2024|Published in the Official Journal on July 12, 2024|113 articles · 13 annexes · 180 recitals
Articles / Annexes↓
Chapter I — GENERAL PROVISIONS
Chapter II — PROHIBITED AI PRACTICES
Chapter III — HIGH-RISK AI SYSTEMS
- 6Classification rules for high-risk AI systems
- 7Amendments to Annex III
- 8Compliance with the requirements
- 9Risk management system
- 10Data and data governance
- 11Technical documentation
- 12Record-keeping
- 13Transparency and provision of information to deployers
- 14Human oversight
- 15Accuracy, robustness and cybersecurity
- 16Obligations of providers of high-risk AI systems
- 17Quality management system
- 18Documentation keeping
- 19Automatically generated logs
- 20Corrective actions and duty of information
- 21Cooperation with competent authorities
- 22Authorised representatives of providers of high-risk AI systems
- 23Obligations of importers
- 24Obligations of distributors
- 25Responsibilities along the AI value chain
- 26Obligations of deployers of high-risk AI systems
- 27Fundamental rights impact assessment for high-risk AI systems
- 28Notifying authorities
- 29Application of a conformity assessment body for notification
- 30Notification procedure
- 31Requirements relating to notified bodies
- 32Presumption of conformity with requirements relating to notified bodies
- 33Subsidiaries of notified bodies and subcontracting
- 34Operational obligations of notified bodies
- 35Identification numbers and lists of notified bodies
- 36Changes to notifications
- 37Challenge to the competence of notified bodies
- 38Coordination of notified bodies
- 39Conformity assessment bodies of third countries
- 40Harmonised standards and standardisation deliverables
- 41Common specifications
- 42Presumption of conformity with certain requirements
- 43Conformity assessment
- 44Certificates
- 45Information obligations of notified bodies
- 46Derogation from conformity assessment procedure
- 47EU declaration of conformity
- 48CE marking
- 49Registration
Chapter IV — TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMS
Chapter V — GENERAL-PURPOSE AI MODELS
- 51Classification of general-purpose AI models as general-purpose AI models with systemic risk
- 52Procedure
- 53Obligations for providers of general-purpose AI models
- 54Authorised representatives of providers of general-purpose AI models
- 55Obligations of providers of general-purpose AI models with systemic risk
- 56Codes of practice
Chapter VI — MEASURES IN SUPPORT OF INNOVATION
- 57AI regulatory sandboxes
- 58Detailed arrangements for, and functioning of, AI regulatory sandboxes
- 59Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
- 60Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
- 61Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
- 62Measures for providers and deployers, in particular SMEs, including start-ups
- 63Derogations for specific operators
Chapter VII — GOVERNANCE
Chapter VIII — EU DATABASE FOR HIGH-RISK AI SYSTEMS
Chapter IX — POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
- 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- 73Reporting of serious incidents
- 74Market surveillance and control of AI systems in the Union market
- 75Mutual assistance, market surveillance and control of general-purpose AI systems
- 76Supervision of testing in real world conditions by market surveillance authorities
- 77Powers of authorities protecting fundamental rights
- 78Confidentiality
- 79Procedure at national level for dealing with AI systems presenting a risk
- 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
- 81Union safeguard procedure
- 82Compliant AI systems which present a risk
- 83Formal non-compliance
- 84Union AI testing support structures
- 85Right to lodge a complaint with a market surveillance authority
- 86Right to explanation of individual decision-making
- 87Reporting of infringements and protection of reporting persons
- 88Enforcement of the obligations of providers of general-purpose AI models
- 89Monitoring actions
- 90Alerts of systemic risks by the scientific panel
- 91Power to request documentation and information
- 92Power to conduct evaluations
- 93Power to request measures
- 94Procedural rights of economic operators of the general-purpose AI model
Chapter X — CODES OF CONDUCT AND GUIDELINES
Chapter XI — DELEGATION OF POWER AND COMMITTEE PROCEDURE
Chapter XII — PENALTIES
Chapter XIII — FINAL PROVISIONS
- 102Amendment to Regulation (EC) No 300/2008
- 103Amendment to Regulation (EU) No 167/2013
- 104Amendment to Regulation (EU) No 168/2013
- 105Amendment to Directive 2014/90/EU
- 106Amendment to Directive (EU) 2016/797
- 107Amendment to Regulation (EU) 2018/858
- 108Amendments to Regulation (EU) 2018/1139
- 109Amendment to Regulation (EU) 2019/2144
- 110Amendment to Directive (EU) 2020/1828
- 111AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
- 112Evaluation and review
- 113Entry into force and application
Annexes
- IList of Union harmonisation legislation
- IIList of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
- IIIHigh-risk AI systems referred to in Article 6(2)
- IVTechnical documentation referred to in Article 11(1)
- VEU declaration of conformity
- VIConformity assessment procedure based on internal control
- VIIConformity based on an assessment of the quality management system and an assessment of the technical documentation
- VIIIInformation to be submitted upon the registration of high-risk AI systems in accordance with Article 49
- IXInformation 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
- XUnion legislative acts on large-scale IT systems in the area of Freedom, Security and Justice
- XITechnical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
- XIITransparency 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
- XIIICriteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
Preamble · Recitals
Recitals (1-180)
Annexes (13)
Annex IList of Union harmonisation legislationAnnex IIList of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)Annex IIIHigh-risk AI systems referred to in Article 6(2)Annex IVTechnical documentation referred to in Article 11(1)Annex VEU declaration of conformityAnnex VIConformity assessment procedure based on internal controlAnnex VIIConformity based on an assessment of the quality management system and an assessment of the technical documentationAnnex VIIIInformation to be submitted upon the registration of high-risk AI systems in accordance with Article 49Annex IXInformation 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 60Annex XUnion legislative acts on large-scale IT systems in the area of Freedom, Security and JusticeAnnex XITechnical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI modelsAnnex XIITransparency 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 systemAnnex XIIICriteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
Final formula
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 June 2024.
For the European Parliament
The President
R. METSOLA
For the Council
The President
M. MICHEL