Articles

• Article 1 Subject matter` amended
• Article 2 Scope amended 2 inserted 3
• Article 3 Definitions amended inserted 2
• Article 4 AI literacy amended
• Article 4a Processing of special categories of personal data for bias detection and correction inserted
• Article 5 Prohibited AI practices inserted 8
• Article 6 Classification rules for high-risk AI systems inserted 3
• Article 7 Amendments to Annex III
• Article 8 Compliance with the requirements
• Article 9 Risk management system
• Article 10 Data and data governance amended 2 deleted
• Article 11 Technical documentation amended
• 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 amended
• 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 amended 2 inserted 3
• Article 26 Obligations of deployers of high-risk AI systems
• Article 27 Fundamental rights impact assessment for high-risk AI systems amended 2
• Article 28 Notifying authorities inserted 2
• Article 29 Application of a conformity assessment body for notification amended
• Article 30 Notification procedure amended
• 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 amended
• Article 41 Common specifications
• Article 42 Presumption of conformity with certain requirements inserted
• Article 43 Conformity assessment amended
• 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
• Article 50 Transparency obligations for providers and deployers of certain AI systems amended
• 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 amended
• Article 57 AI regulatory sandboxes amended 6 inserted
• Article 58 Detailed arrangements for, and functioning of, AI regulatory sandboxes amended inserted
• 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 amended 2
• Article 60a Testing of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes inserted
• 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 amended
• Article 64 AI Office inserted
• 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 amended
• Article 70 Designation of national competent authorities and single points of contact amended
• Article 71 EU database for high-risk AI systems listed in Annex III
• Article 72 Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems amended
• Article 73 Reporting of serious incidents
• Article 74 Market surveillance and control of AI systems in the Union market
• Article 75 Market surveillance and control of AI systems and mutual assistance amended
• Article 75a Supervisory and enforcement powers of the AI Office inserted
• Article 75b Commitments inserted
• Article 75c Non-compliance, fines and periodic penalty payments inserted
• Article 75d Safeguards and further specification inserted
• Article 76 Supervision of testing in real world conditions by market surveillance authorities amended
• Article 77 Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities amended
• 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
• Article 95 Codes of conduct for voluntary application of specific requirements amended
• Article 96 Guidelines from the Commission on the implementation of this Regulation amended 2 inserted
• Article 97 Exercise of the delegation amended 3
• Article 98 Committee procedure
• Article 99 Penalties amended inserted 2
• Article 100 Administrative fines on Union institutions, bodies, offices and agencies
• Article 101 Fines for providers of general-purpose AI models
• 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 amended inserted
• Article 112 Evaluation and review
• Article 113 Entry into force and application amended 2 inserted 3

Annexes

• ANNEX I List of Union harmonisation legislation inserted deleted
• 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 deleted 2
• 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
• ANNEX XIV inserted