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Table of Contents

CHAPTER I GENERAL PROVISIONS
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  • Article 1 Subject matter`
  • Article 2 Scope
  • Article 3 Definitions
  • Article 4 AI literacy
CHAPTER II PROHIBITED AI PRACTICES
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  • Article 5 Prohibited AI practices
CHAPTER III HIGH-RISK AI SYSTEMS
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SECTION 1 — Classification of AI systems as high-risk
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  • Article 6 Classification rules for high-risk AI systems
  • Article 7 Amendments to Annex III
SECTION 2 — Requirements for high-risk AI systems
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  • 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
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  • 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
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  • 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
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  • 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
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  • Article 50 Transparency obligations for providers and deployers of certain AI systems
CHAPTER V GENERAL-PURPOSE AI MODELS
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SECTION 1 — Classification rules
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  • 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
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  • 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
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  • Article 55 Obligations of providers of general-purpose AI models with systemic risk
SECTION 4 — Codes of practice
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  • Article 56 Codes of practice
CHAPTER VI MEASURES IN SUPPORT OF INNOVATION
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  • 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
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SECTION 1 — Governance at Union level
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  • 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
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  • Article 70 Designation of national competent authorities and single points of contact
CHAPTER VIII EU DATABASE FOR HIGH-RISK AI SYSTEMS
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  • Article 71 EU database for high-risk AI systems listed in Annex III
CHAPTER IX POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCE
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SECTION 1 — Post-market monitoring
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  • 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
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  • Article 73 Reporting of serious incidents
SECTION 3 — Enforcement
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  • 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
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  • 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
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  • 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
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  • 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
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  • Article 97 Exercise of the delegation
  • Article 98 Committee procedure
CHAPTER XII PENALTIES
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  • 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
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  • 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
Annexes
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  • Annex I List of Union harmonisation legislation
  • Annex II List of criminal offences referred to in Article 5(1), first subparagraph, point (h)(iii)
  • Annex III High-risk AI systems referred to in Article 6(2)
  • Annex IV Technical documentation referred to in Article 11(1)
  • Annex V EU declaration of conformity
  • Annex VI Conformity assessment procedure based on internal control
  • Annex VII Conformity based on an assessment of the quality management system and an assessment of the technical documentation
  • Annex VIII Information to be submitted upon the registration of high-risk AI systems in accordance with Article 49
  • 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
  • Annex X
  • Annex XI Technical documentation referred to in Article 53(1), point (a) — technical documentation for providers of general-purpose AI models
  • 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
  • Annex XIII Criteria for the designation of general-purpose AI models with systemic risk referred to in Article 51
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