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Table of Contents
Title I: General Provisions
Art. 1 Subject MatterArt. 2 ScopeArt. 3 DefinitionsArt. 4 Amendments to Annex I
Title IA: General Purpose AI Systems
Art. 4a Compliance of General Purpose AI Systems with this RegulationArt. 4b Requirements for General Purpose AI Systems and Obligations for Providers of such SystemsArt. 4c Exceptions to Article 4b
Title II: Prohibited Artificial Intelligence Practices
Art. 5 Prohibited Artificial Intelligence Practices
Title III: Classification of AI Systems as High-Risk
Chapter 1: Classification of AI Systems as High-Risk
Art. 6 Classification Rules for High-Risk AI Systems
Art. 7 Amendments to Annex IIIChapter 2: Requirements for High-Risk AI Systems
Art. 8 Compliance with the Requirements
Art. 9 Risk Management System
Art. 10 Data and Data Governance
Art. 11 Technical Documentation
Art. 12 Record-Keeping
Art. 13 Transparency and Provision of Information to Users
Art. 14 Human Oversight
Art. 15 Accuracy, Robustness and Cybersecurity
Chapter 3: Obligations of Providers and Users of High-Risk AI Systems and Other Parties
Art. 16 Obligations of Providers of High-Risk AI Systems
Art. 17 Quality Management System
Art. 18 Obligation to Draw Up Technical Documentation
Art. 19 Conformity Assessment
Art. 20 Automatically Generated Logs
Art. 21 Corrective Actions
Art. 22 Duty of Information
Art. 23 Cooperation with Competent Authorities
Art. 23a Conditions for Other Persons to be Subject to the Obligations of a Provider
Art. 24 [Deleted]
Art. 25 Authorised Representatives
Art. 26 Obligations of Importers
Art. 27 Obligations of Distributors
Art. 28 [Deleted]
Art. 29 Obligations of Users of High-Risk AI Systems
Chapter 4: Notifying Authorities and Notified Bodies
Art. 30 Notifying Authorities
Art. 31 Application of a Conformity Assessment Body for Notification
Art. 32 Notification Procedure
Art. 33 Requirements Relating to Notified BodiesArt. 33a Presumption of Conformity with Requirements Relating to Notified BodiesArt. 34 Subsidiaries of and Subcontracting by Notified Bodies
Art. 34a Operational Obligations of Notified Bodies
Art. 35 Identification Numbers and Lists of Notified Bodies Designated Under This Regulation
Art. 36 Changes to Notifications
Art. 37 Challenge to the Competence of Notified Bodies
Art. 38 Coordination of Notified Bodies
Art. 39 Conformity Assessment Bodies of Third Countries
Chapter 5: Standards, Conformity Assessment, Certification, Registration
Art. 40 Harmonised Standards
Art. 41 Common Specifications
Art. 42 Presumption of Conformity with Certain Requirements
Art. 43 Conformity Assessment
Art. 44 Certificates
Art. 45 Appeal Against Decisions of Notified Bodies
Art. 46 Information Obligations of Notified Bodies
Art. 47 Derogation From Conformity Assessment Procedure
Art. 48 EU Declaration of Conformity
Art. 49 CE Marking of Conformity
Art. 50 [Deleted]Art. 51 Registration of Relevant Operators and of High-Risk AI Systems Listed in Annex III
Title IV: Transparency Obligations for Certain AI Systems
Art. 52 Transparency Obligations for Providers and Users of Certain AI Systems
Title V: Measures in Support of Innovation
Art. 53 AI Regulatory SandboxesArt. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory SandboxArt. 54a Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory SandboxesArt. 54b Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory SandboxesArt. 55 Support Measures for Operators, in Particular SMEs, including Start-UpsArt. 55a Derogations for Specific Operators
Title VI: Governance
Chapter 1: European Artificial Intelligence Board
Art. 56 Establishment of the European Artificial Intelligence BoardArt. 57 [Deleted]
Art. 58 Tasks of the BoardChapter 1A: Guidelines From The Commission
Art. 58a Guidelines from the Commission on the Implementation of This RegulationChapter 2: National Competent Authorities
Art. 59 Designation of National Competent Authorities
Title VII: EU Database for Stand-Alone High-Risk AI Systems
Art. 60 EU Database for High-Risk AI Systems Listed in Annex III
Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance
Chapter 1: Post-Market Monitoring
Art. 61 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI SystemsChapter 2: Sharing of Information on Incidents and Malfunctioning
Art. 62 Reporting of Serious Incidents and of MalfunctioningChapter 3: Enforcement
Art. 63 Market Surveillance and Control of AI Systems in the Union MarketArt. 63a Supervision of Testing in Real World Conditions by Market Surveillance AuthoritiesArt. 64 Powers of Authorities Protecting Fundamental RightsArt. 65 Procedure for Dealing with AI Systems Presenting a Risk at National LevelArt. 66 Union Safeguard ProcedureArt. 67 Compliant AI Systems Which Present a RiskArt. 68 Formal Non-ComplianceArt. 68a Union Testing Facilities in the Area of Artificial IntelligenceArt. 68b Central Pool of Independent Experts
Title IX: Codes of Conduct
Art. 69 Codes of Conduct for Voluntary Application of Specific Requirements
Title X: Confidentiality and Penalties
Art. 70 Confidentiality
Art. 71 PenaltiesArt. 72 Administrative Fines on Union Institutions, Agencies and Bodies
Title XI: Delegation of Power and Committee Procedure
Art. 73 Exercise of the DelegationArt. 74 Committee Procedure
Title XII: Final Provisions
Art. 75 Amendment to Regulation (EC) No 300/2008Art. 76 Amendment to Regulation (EU) No 167/2013Art. 77 Amendment to Regulation (EU) No 168/2013Art. 78 Amendment to Directive 2014/90/EUArt. 79 Amendment to Directive (EU) 2016/797Art. 80 Amendment to Regulation (EU) 2018/858Art. 81 Amendment to Regulation (EU) 2018/1139Art. 82 Amendment to Regulation (EU) 2019/2144Art. 83 AI Systems Already Placed on the Market or Put Into ServiceArt. 84 Evaluation and ReviewArt. 85 Entry Into Force and Application
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Article 33a

Presumption of Conformity with Requirements Relating to Notified Bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 33 in so far as the applicable harmonised standards cover those requirements.

Suitable Recitals
(5) Harmonised Rules on Artificial Intelligence
(61) Harmonised Standards
Article 1
Article 2
Article 3
Article 4
Article 4a
Article 4b
Article 4c
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23
Article 23a
Article 24
Article 25
Article 26
Article 27
Article 28
Article 29
Article 30
Article 31
Article 32
Article 33
Article 33a
Article 34
Article 34a
Article 35
Article 36
Article 37
Article 38
Article 39
Article 40
Article 41
Article 42
Article 43
Article 44
Article 45
Article 46
Article 47
Article 48
Article 49
Article 50
Article 51
Article 52
Article 53
Article 54
Article 54a
Article 54b
Article 55
Article 55a
Article 56
Article 57
Article 58
Article 58a
Article 59
Article 60
Article 61
Article 62
Article 63
Article 63a
Article 64
Article 65
Article 66
Article 67
Article 68
Article 68a
Article 68b
Article 69
Article 70
Article 71
Article 72
Article 73
Article 74
Article 75
Article 76
Article 77
Article 78
Article 79
Article 80
Article 81
Article 82
Article 83
Article 84
Article 85
EU AI Act Table of Contents
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