Table of Contents

Article 1: Subject matter

Article 2: Scope

Article 3: Definitions

Article 4: AI literacy

Article 5: Prohibited AI practices

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

Article 50: Transparency obligations for providers and deployers of certain AI systems

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

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

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

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

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

Article 95: Codes of conduct for voluntary application of specific requirements

Article 96: Guidelines from the Commission on the implementation of this Regulation

Article 97: Exercise of the delegation

Article 98: Committee procedure

Article 99: Penalties

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

Article 112: Evaluation and review

Article 113: Entry into force and application