Chapter I — General Provisions
Chapter II — Prohibited AI Practices
Chapter III — High-Risk AI Systems
- Article 6 Classification rules for high-risk AI systems
- Article 7 Amendments to Annex III
- 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
- 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
- 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
- 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
Chapter V — General-Purpose AI Models
- Article 51 Classification of general-purpose AI models as general-purpose AI models with systemic risk
- Article 52 Procedure
- Article 53 Obligations for providers of general-purpose AI models
- Article 54 Authorised representatives of providers of general-purpose AI models
- Article 55 Obligations of providers of general-purpose AI models with systemic risk
- 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
- 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
- Article 70 Designation of national competent authorities and single points of contact
Chapter VIII — EU Database For High-Risk AI Systems
Chapter IX — Post-Market Monitoring, Information Sharing And Market Surveillance
- Article 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- Article 73 Reporting of serious incidents
- 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
- 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
- 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
Chapter XI — Delegation Of Power And Committee Procedure
Chapter XII — Penalties
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