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Chapter I: General Provisions
[Deleted] Title IA: General Purpose AI Systems
Chapter II: Prohibited AI Practices
Chapter III: High Risk AI Systems
Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
[Deleted] Title V: General Purpose AI Models
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
Chapter VII: Governance
Chapter VIII: EU Data for High-Risk AI Systems
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
Chapter X: Codes of Conduct and Guidelines
Chapter XI: Delegation of Power and Committee Procedure
Chapter XII: Penalties
Chapter XIII: Final Provisions
Section 1: Classification of AI Systems as High-Risk
[Deleted] Chapter 1A: Scientific Panel of Independent Experts
Section 2: Requirements for High-Risk AI Systems
Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
Section 4: Notifying Authorities and Notified Bodies
Section 5: Standards, Conformity Assessment, Certification, Registration
Section 1: Classification Rules
[Deleted] Chapter 1: Classification Rules
Section 2: Obligations for Providers of General Purpose AI Models
[Deleted] Chapter 1: Governance at Union Level
[Deleted] Chapter 2: Obligations for Providers of General Purpose AI Models
Section 1: Governance at Union Level
Section 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
[Deleted] Chapter 2: National Competent Authorities
[Deleted] Chapter 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Section 2: National Competent Authorities
Section 4: Codes of Practice
[Deleted] Chapter 1: Post-Market Monitoring
[Deleted] Chapter 2: Sharing of Information on Serious Incidents
Section 1: Post-Market Monitoring
Section 2: Sharing of Information on Serious Incidents
[Deleted] Chapter 3: Enforcement
[Deleted] Chapter 3a: Enforcement
[Deleted] Chapter 3b: Remedies
[Deleted] Chapter 3c: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models
Section 3: Enforcement
Section 4: Remedies
[Deleted] Chapter 4: Remedies
Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
[Deleted] Chapter 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
Art. 1 Subject Matter
Art. 2 Scope
Art. 3 Definitions
Art. 4 AI Literacy
Art. 4a [Deleted]
Art. 4b [Deleted]
Art. 4c [Deleted]
Art. 5 Prohibited AI Practices
Art. 6 Classification Rules for High-Risk AI Systems
Art. 7 Amendments to Annex III
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
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 of Providers of High-Risk AI Systems
Art. 23 Obligations of Importers
Art. 23a [Deleted]
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 for High-Risk AI Systems
Art. 28 Notifying Authorities
Art. 29 Application of a Conformity Assessment Body for Notification
Art. 29a [Deleted]
Art. 30 Notification Procedure
Art. 31 Requirements Relating to Notified Bodies
Art. 32 Presumption of Conformity with Requirements Relating to Notified Bodies
Art. 33 Subsidiaries of Notified Bodies and Subcontracting
Art. 33a [Deleted]
Art. 34 Operational Obligations of Notified Bodies
Art. 34a [Deleted]
Art. 35 Identification Numbers and Lists of Notified Bodies
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
Art. 40 Harmonised Standards and Standardisation Deliverables
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 Procedure
Art. 47 EU Declaration of Conformity
Art. 48 CE Marking
Art. 49 Registration
Art. 50 Transparency Obligations for Providers and Deployers of Certain AI Systems
Art. 51 Classification of General-Purpose AI Models as General-Purpose AI Models with Systemic Risk
Art. 52 Procedure
Art. 52a [Deleted]
Art. 52b [Deleted]
Art. 52c [Deleted]
Art. 52ca [Deleted]
Art. 52d [Deleted]
Art. 52e [Deleted]
Art. 53 Obligations for Providers of General-Purpose AI Models
Art. 53a [Deleted]
Art. 54 Authorised Representatives of Providers of General-Purpose AI Models
Art. 54a [Deleted]
Art. 54b [Deleted]
Art. 55 Obligations for Providers of General-Purpose AI Models with Systemic Risk
Art. 55a [Deleted]
Art. 55b [Deleted]
Art. 56 Codes of Practice
Art. 57 AI Regulatory Sandboxes
Art. 58 Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Art. 58a [Deleted]
Art. 58b [Deleted]
Art. 58c [Deleted]
Art. 59 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Art. 60 Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Art. 61 Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Art. 62 Measures for Providers and Deployers, in Particular SMEs, including Start-Ups
Art. 63 Derogations for Specific Operators
Art. 63a [Deleted]
Art. 63b [Deleted]
Art. 64 AI Office
Art. 65 Establishment and Structure of the European Artificial Intelligence Board
Art. 65a [Deleted]
Art. 66 Tasks of the Board
Art. 67 Advisory Forum
Art. 68 Scientific Panel of Independent Experts
Art. 68a [Deleted]
Art. 68b [Deleted]
Art. 68c [Deleted]
Art. 68d [Deleted]
Art. 68e [Deleted]
Art. 68f [Deleted]
Art. 68g [Deleted]
Art. 68h [Deleted]
Art. 68i [Deleted]
Art. 68j [Deleted]
Art. 68k [Deleted]
Art. 68m [Deleted]
Art. 69 Access to the Pool of Experts by the Member States
Art. 70 Designation of National Competent Authorities and Single Point of Contact
Art. 71 EU Database for High-Risk AI Systems Listed in Annex III
Art. 72 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
Art. 72a [Deleted]
Art. 73 Reporting of Serious Incidents
Art. 74 Market Surveillance and Control of AI Systems in the Union Market
Art. 75 Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
Art. 76 Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Art. 77 Powers of Authorities Protecting Fundamental Rights
Art. 78 Confidentiality
Art. 79 Procedure at National Level for Dealing with AI Systems Presenting a Risk
Art. 80 Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
Art. 81 Union Safeguard Procedure
Art. 82 Compliant AI Systems which Present a Risk
Art. 82a [Deleted]
Art. 83 Formal Non-Compliance
Art. 84 Union AI Testing Support Structures
Art. 85 Right to Lodge a Complaint with a Market Surveillance Authority
Art. 86 Right to Explanation of Individual Decision-Making
Art. 87 Reporting of Infringements and Protection of Reporting Persons
Art. 88 Enforcement of the Obligations of Providers of General-Purpose AI Models
Art. 89 Monitoring Actions
Art. 90 Alerts of Systemic Risks by the Scientific Panel
Art. 91 Power to Request Documentation and Information
Art. 92 Power to Conduct Evaluations
Art. 93 Power to Request Measures
Art. 94 Procedural Rights of Economic Operators of the General-Purpose AI Model
Art. 95 Codes of Conduct for Voluntary Application of Specific Requirements
Art. 96 Guidelines from the Commission on the Implementation of this Regulation
Art. 97 Exercise of the Delegation
Art. 98 Committee Procedure
Art. 99 Penalties
Art. 100 Administrative Fines on Union Institutions, Bodies, Offices and Agencies
Art. 101 Fines for Providers of General-Purpose AI Models
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 Amendment 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 or Put into Service and General-Purpose AI Models Already Placed on the Marked
Art. 112 Evaluation and Review
Art. 113 Entry into Force and Application
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Annex I: List of Union Harmonisation Legislation
Annex II: List of Criminal Offences Referred to in Article 5(1), First Subparagraph, Point (h)(iii)
Annex IIa: [Deleted]
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
Annex VIIIa: [Deleted]
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 IXa: [Deleted]
Annex IXb: [Deleted]
Annex IXc: [Deleted]
Annex X: Union Legislative Acts on Large-Scale IT Systems in the Area of Freedom, Security and Justice
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
Key Issue 1: Fines/Penalties
Key Issue 2: Conformity Assessment and Self-Assessment
Key Issue 3: Risk-Based Approach
Key Issue 4: Human Oversight
Key Issue 5: Transparency Obligations
Key Issue 6: Interplay with GDPR
AI Act
Recitals
Annexes
Key Issues
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