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Ch. 1 General Provisions
  • Art. 1 Subject Matter
  • Art. 2 Scope
  • Art. 3 Definitions
  • Art. 4 AI literacy
Ch. 2 Prohibited AI Practices
  • Art. 5 Prohibited AI Practices
Ch. 3 High-Risk AI System
  • Section 1: Classification of AI Systems as High-Risk
    • Art. 6 Classification Rules for High-Risk AI Systems
    • Art. 7 Amendments to Annex III
  • Section 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 Deployers
    • Art. 14 Human Oversight
    • Art. 15 Accuracy, Robustness and Cybersecurity
  • Section 3: Obligations of Providers and Deployers and Other Parties
    • Art. 16 Obligations of Providers of High-Risk AI Systems
    • Art. 17 Quality Management System
    • Art. 18 Documentation Keeping
    • Art. 19 Automatically Generated Logs
    • Art. 20 Corrective Actions and Duty of Information
    • Art. 21 Cooperation with Competent Authorities
    • Art. 22 Authorised Representatives
    • Art. 23 Obligations of Importers
    • Art. 24 Obligations of Distributors
    • Art. 25 Responsibilities Along the AI Value Chain
    • Art. 26 Obligations of Deployers of High-Risk AI Systems
    • Art. 27 Fundamental Rights Impact Assessment
  • Section 4: Notifying Authorities and Notified Bodies
    • Art. 28 Notifying Authorities
    • Art. 29 Application of a Conformity Assessment Body
    • Art. 30 Notification Procedure
    • Art. 31 Requirements Relating to Notified Bodies
    • Art. 32 Presumption of Conformity
    • Art. 33 Subsidiaries and Subcontracting
    • Art. 34 Operational Obligations of Notified Bodies
    • Art. 35 Identification Numbers and Lists
    • Art. 36 Changes to Notifications
    • Art. 37 Challenge to Competence of Notified Bodies
    • Art. 38 Coordination of Notified Bodies
    • Art. 39 Conformity Assessment Bodies of Third Countries
  • Section 5: Standards, Conformity Assessment, Certificates, 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 Information Obligations of Notified Bodies
    • Art. 46 Derogation from Conformity Assessment
    • Art. 47 EU Declaration of Conformity
    • Art. 48 CE Marking
    • Art. 49 Registration
Ch. 4 Transparency Obligations for Providers and Deployers of Certain AI Systems
  • Art. 50 Transparency Obligations
Ch. 5 General-Purpose AI Models
  • Section 1: Classification Rules
    • Art. 51 Classification as GPAI with Systemic Risk
    • Art. 52 Procedure
  • Section 2: Obligations for Providers of GPAI Models
    • Art. 53 Obligations for Providers of GPAI Models
    • Art. 54 Authorised Representatives
  • Section 3: Obligations of Providers of GPAI with Systemic Risk
    • Art. 55 Obligations for GPAI with Systemic Risk
  • Section 4: Codes of Practice
    • Art. 56 Codes of Practice
Ch. 6 Measures in Support of Innovation
  • Art. 57 AI Regulatory Sandboxes
  • Art. 58 Detailed Arrangements for AI Regulatory Sandboxes
  • Art. 59 Further Processing of Personal Data
  • Art. 60 Testing in Real World Conditions
  • Art. 61 Informed Consent
  • Art. 62 Measures for SMEs and Start-Ups
  • Art. 63 Derogations for Specific Operators
Ch. 7 Governance
  • Section 1: Governance at Union Level
    • Art. 64 AI Office
    • Art. 65 European AI Board
    • Art. 66 Tasks of the Board
    • Art. 67 Advisory Forum
    • Art. 68 Scientific Panel
    • Art. 69 Access to Pool of Experts
  • Section 2: National Competent Authorities
    • Art. 70 Designation of National Competent Authorities
Ch. 8 EU Database for High-Risk AI Systems
  • Art. 71 EU Database for High-Risk AI Systems
Ch. 9 Post-Market Monitoring, Information Sharing and Market Surveillance
  • Section 1: Post-Market Monitoring
    • Art. 72 Post-Market Monitoring by Providers
  • Section 2: Sharing of Information on Serious Incidents
    • Art. 73 Reporting of Serious Incidents
  • Section 3: Enforcement
    • Art. 74 Market Surveillance and Control
    • Art. 75 Mutual Assistance and Market Surveillance
    • Art. 76 Supervision of Testing
    • Art. 77 Powers of Authorities Protecting Fundamental Rights
    • Art. 78 Confidentiality
    • Art. 79 Procedure at National Level
    • Art. 80 Procedure for AI Systems Classified as Non-High-Risk
    • Art. 81 Union Safeguard Procedure
    • Art. 82 Compliant AI Systems Presenting a Risk
    • Art. 83 Formal Non-Compliance
    • Art. 84 Union AI Testing Support Structures
  • Section 4: Remedies
    • Art. 85 Right to Lodge a Complaint
    • Art. 86 Right to Explanation
    • Art. 87 Reporting of Infringements
  • Section 5: Supervision and Enforcement for GPAI Models
    • Art. 88 Enforcement of GPAI Obligations
    • Art. 89 Monitoring Actions
    • Art. 90 Alerts of Systemic Risks
    • Art. 91 Power to Request Documentation
    • Art. 92 Power to Conduct Evaluations
    • Art. 93 Power to Request Measures
    • Art. 94 Procedural Rights of Economic Operators
Ch. 10 Codes of Conduct and Guidelines
  • Art. 95 Codes of Conduct for Voluntary Application
  • Art. 96 Guidelines from the Commission
Ch. 11 Delegation of Power and Committee Procedure
  • Art. 97 Exercise of the Delegation
  • Art. 98 Committee Procedure
Ch. 12 Penalties
  • Art. 99 Penalties
  • Art. 100 Administrative Fines on Union Bodies
  • Art. 101 Fines for GPAI Providers
Ch. 13 Final Provisions
  • Art. 102 Amendment to Regulation (EC) No 300/2008
  • Art. 103 Amendment to Regulation (EU) No 167/2013
  • Art. 104 Amendment to Regulation (EU) No 168/2013
  • Art. 105 Amendment to Directive 2014/90/EU
  • Art. 106 Amendment to Directive (EU) 2016/797
  • Art. 107 Amendment to Regulation (EU) 2018/858
  • Art. 108 Amendments to Regulation (EU) 2018/1139
  • Art. 109 Amendment to Regulation (EU) 2019/2144
  • Art. 110 Amendment to Directive (EU) 2020/1828
  • Art. 111 AI Systems Already Placed on the Market
  • Art. 112 Evaluation and Review
  • Art. 113 Entry into Force and Application
Annexes
  • Annex I: List of Union Harmonisation Legislation
  • Annex II: List of Criminal Offences Referred to in Article 5(1)(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 Based on Internal Control
  • Annex VII: Conformity Based on Assessment of QMS and Technical Documentation
  • Annex VIII: Information for Registration of High-Risk AI Systems (Article 49)
  • Annex IX: Information for Registration for Testing (Article 60)
  • Annex X: Union Legislative Acts on Large-Scale IT Systems
  • Annex XI: Technical Documentation for GPAI Models (Article 53(1)(a))
  • Annex XII: Transparency Information for GPAI Models (Article 53(1)(b))
  • Annex XIII: Criteria for GPAI with Systemic Risk (Article 51)
Recitals
[1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11] [12] [13] [14] [15] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] [35] [36] [37] [38] [39] [40] [41] [42] [43] [44] [45] [46] [47] [48] [49] [50] [51] [52] [53] [54] [55] [56] [57] [58] [59] [60] [61] [62] [63] [64] [65] [66] [67] [68] [69] [70] [71] [72] [73] [74] [75] [76] [77] [78] [79] [80] [81] [82] [83] [84] [85] [86] [87] [88] [89] [90] [91] [92] [93] [94] [95] [96] [97] [98] [99] [100] [101] [102] [103] [104] [105] [106] [107] [108] [109] [110] [111] [112] [113] [114] [115] [116] [117] [118] [119] [120] [121] [122] [123] [124] [125] [126] [127] [128] [129] [130] [131] [132] [133] [134] [135] [136] [137] [138] [139] [140] [141] [142] [143] [144] [145] [146] [147] [148] [149] [150] [151] [152] [153] [154] [155] [156] [157] [158] [159] [160] [161] [162] [163] [164] [165] [166] [167] [168] [169] [170] [171] [172] [173] [174] [175] [176] [177] [178] [179] [180]
Chapter III: High-Risk AI System
Chapter 3

Chapter III:

High-Risk AI System

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