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Title I: General Provisions
Title IA: General Purpose AI Systems
Title II: Prohibited Artificial Intelligence Practices
Title III: Classification of AI Systems as High-Risk
Title IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Title VIIIa: General Purpose AI Models
Title V: Measures in Support of Innovation
Title VI: Governance
Title VII: EU Database for High-Risk AI Systems Listed in Annex III
Title VIII: Post-Market Monitoring, Information Sharing, Market Surveillance
Title IX: Codes of Conduct
Title X: Confidentiality and Penalties
Title XI: Delegation of Power and Committee Procedure
Title XII: Final Provisions
Chapter 1: Classification of AI Systems as High-Risk
Chapter 2: Requirements for High-Risk AI Systems
Chapter 3: Obligations of Providers and Users of High-Risk AI Systems and Other Parties
Chapter 4: Notifying Authorities and Notified Bodies
Chapter 5: Standards, Conformity Assessment, Certification, Registration
Chapter 1: Classification Rules
Chapter 2: Obligations for Providers of General Purpose AI Models
Chapter 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Chapter 1: European Artificial Intelligence Board
Chapter 1A: Scientific Panel of Independent Experts
Chapter 2: National Competent Authorities
Chapter 1: Post-Market Monitoring
Chapter 2: Sharing of Information on Serious Incidents
Chapter 3: Enforcement
Chapter 3a: Remedies
Chapter 3c: 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 Implementing Acts
Art. 4a Compliance of General Purpose AI Systems with this Regulation
Art. 4b AI Literacy
Art. 4c Exceptions to Article 4b
Art. 5 Prohibited Artificial Intelligence 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 Conformity Assessment
Art. 20 Automatically Generated Logs
Art. 21 Corrective Actions and Duty of Information
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 Responsibilities along the AI Value Chain
Art. 29 Obligations of Deployers of High-Risk AI Systems
Art. 29a Fundamental Rights Impact Assessment for High-Risk AI Systems
Art. 30 Notifying Authorities
Art. 31 Application of a Conformity Assessment Body for Notification
Art. 32 Notification Procedure
Art. 33 Requirements Relating to Notified Bodies
Art. 33a Presumption of Conformity with Requirements Relating to Notified Bodies
Art. 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
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 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
Art. 52 Transparency Obligations for Providers and Users of Certain AI Systems
Art. 52a Classification of General Purpose AI Models as General Purpose AI Models with Systemic Risk
Art. 52b Procedure
Art. 52c Obligations for Providers of General Purpose AI Models
Art. 52ca Authorised Representative
Art. 52d Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 52e Codes of Practice
Art. 53 AI Regulatory Sandboxes
Art. 53a Modalities and Functioning of AI Regulatory Sandboxes
Art. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Art. 54a Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Art. 54b Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Art. 55 Measures for Deployers, in Particular SMEs, including Start-Ups
Art. 55a Derogations for Specific Operators
Art. 55b Governance at Union Level
Art. 56 Establishment and Structure of the European Artificial Intelligence Board
Art. 57 [Deleted]
Art. 58 Tasks of the Board
Art. 58a Advisory Forum
Art. 58b Scientific Panel of Independent Experts
Art. 58c Access to the Pool of Experts by the Member States
Art. 59 Designation of National Competent Authorities and Single Point of Contact
Art. 60 EU Database for High-Risk AI Systems Listed in Annex III
Art. 61 Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
Art. 62 Reporting of Serious Incidents
Art. 63 Market Surveillance and Control of AI Systems in the Union Market
Art. 63a Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems
Art. 63b Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Art. 64 Powers of Authorities Protecting Fundamental Rights
Art. 65 Procedure for Dealing with AI Systems Presenting a Risk at National Level
Art. 65a Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III
Art. 66 Union Safeguard Procedure
Art. 67 Compliant AI Systems which Present a Risk
Art. 68 Formal Non-Compliance
Art. 68a EU AI Testing Support Structures in the Area of Artificial Intelligence
Art. 68b Right to Lodge a Complaint with a Market Surveillance Authority
Art. 68c A Right to Explanation of Individual Decision-Making
Art. 68d Amendment to Directive (EU) 2020/1828
Art. 68e Reporting of Breaches and Protection of Reporting Persons
Art. 68f Enforcement of Obligations on Providers of General Purpose AI Models
Art. 68g Monitoring Actions
Art. 68h Alerts of Systemic Risks by the Scientific Panel
Recital 1
Recital 1a
Recital 2
Recital 3
Recital 4
Recital 4a
Recital 4aa
Recital 5
Recital 5a
Recital 5aa
Recital 5ab
Recital 6
Recital 6a
Recital 6b
Recital 6c
Recital 6d
Recital 7
Recital 7a
Recital 7b
Recital 8
Recital 9
Recital 8a
Recital 9b
Recital 10
Recital 11
Recital 12
Recital -12a
Recital 12a
Recital 12b
Recital 12c
Recital 13
Recital 14
Recital 14a
Recital 15
Recital 16
Recital 16a
Recital 17
Recital 18
Recital 19
Recital 20
Recital 21
Recital 21a
Recital 22
Recital 23
Recital 24
Recital 25
Recital 26
Recital 26a
Recital 26b
Recital 26c
Recital 26d
Recital 27
Recital 28
Recital 28a
Recital 29
Recital 30
Recital 31
Recital 32
Recital 32a
Recital 33
Recital 33a
Recital 34
Recital 35
Recital 36
Recital 37
Recital 38
Recital 39
Recital 40
Recital 40a
Recital 41
Recital 42
Recital 42a
Recital 43
Recital 44
Recital 44a
Recital 45
Recital 45a
Recital 44c
Recital 46
Recital 47
Recital 68
Recital 48
Recital 49
Recital 50
Recital 51
Recital 51a
Recital 52
Recital 52a
Recital 53
Recital 53a
Recital 54
Recital 54a
Recital 55
Recital 56
Recital 56a
Recital 57
Recital 57a
Recital 57b
Recital 57c
Recital 57d
Annex I: [Deleted]
Annex II: List of Union Harmonisation Legislation
Annex IIa: List of Criminal Offences Referred to in Article 5 (1)(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 Assessment of Quality Management System and Assessment of Technical Documentation
Annex VIII: Information to be Submitted Upon the Registration of High-Risk AI Systems in Accordance with Article 51
Annex VIIIa: 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 54a
Annex IX: Union Legislation on Large-Scale IT Systems in the Area of Freedom, Security and Justice
Annex IXa: Technical Documentation Referred to in Article 52c(1a): Technical Documentation for Providers of General Purpose AI Models
Annex IXb: Transparency Information Referred to in Article 52c(1b): Technical Documentation for Providers of General Purpose AI Models to Downstream Providers that Integrate the Model into Their AI System
Annex IXc: Criteria for the Designation of General Purpose AI Models with Systemic Risk Referred to in Article 52a
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
News
Table of Contents
Title I: General Provisions
Art. 1 Subject Matter
Art. 2 Scope
Art. 3 Definitions
Art. 4 Implementing Acts
Title IA: General Purpose AI Systems
Art. 4a Compliance of General Purpose AI Systems with this Regulation
Art. 4b AI Literacy
Art. 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 III
Chapter 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
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 Documentation Keeping
Art. 19 Conformity Assessment
Art. 20 Automatically Generated Logs
Art. 21 Corrective Actions and Duty of Information
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 Responsibilities along the AI Value Chain
Art. 29 Obligations of Deployers of High-Risk AI Systems
Art. 29a Fundamental Rights Impact Assessment for 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 Bodies
Art. 33a Presumption of Conformity with Requirements Relating to Notified Bodies
Art. 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 and Standardisation Deliverables
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
Title IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Art. 52 Transparency Obligations for Providers and Users of Certain AI Systems and GPAI Models
Title VIIIa: General Purpose AI Models
Chapter 1: Classification Rules
Art. 52a Classification of General Purpose AI Models as General Purpose AI Models with Systemic Risk
Art. 52b Procedure
Chapter 2: Obligations for Providers of General Purpose AI Models
Art. 52c Obligations for Providers of General Purpose AI Models
Art. 52ca Authorised Representative
Chapter 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 52d Obligations for Providers of General Purpose AI Models with Systemic Risk
Art. 52e Codes of Practice
Title V: Measures in Support of Innovation
Art. 53 AI Regulatory Sandboxes
Art. 53a Modalities and Functioning of AI Regulatory Sandboxes
Art. 54 Further Processing of Personal Data for Developing Certain AI Systems in the Public Interest in the AI Regulatory Sandbox
Art. 54a Testing of High-Risk AI Systems in Real World Conditions Outside AI Regulatory Sandboxes
Art. 54b Informed Consent to Participate in Testing in Real World Conditions Outside AI Regulatory Sandboxes
Art. 55 Measures for Deployers, in Particular SMEs, including Start-Ups
Art. 55a Derogations for Specific Operators
Title VI: Governance
Art. 55b Governance at Union Level
Chapter 1: European Artificial Intelligence Board
Art. 56 Establishment of the European Artificial Intelligence Board
Art. 57 [Deleted]
Art. 58 Tasks of the Board
Art. 58a Advisory Forum
Chapter 1A: Scientific Panel of Independent Experts
Art. 58b Scientific Panel of Independent Experts
Art. 58c Access to the Pool of Experts by the Member States
Chapter 2: National Competent Authorities
Art. 59 Designation of National Competent Authorities and Single Point of Contact
Title VII: EU Database for High-Risk AI Systems Listed in Annex III
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 Systems
Chapter 2: Sharing of Information on Serious Incidents
Art. 62 Reporting of Serious Incidents
Chapter 3: Enforcement
Art. 63 Market Surveillance and Control of AI Systems in the Union Market
Art. 63a Mutual Assistance, Market Surveillance and Control of General Purpose AI Systems
Art. 63b Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Art. 64 Powers of Authorities Protecting Fundamental Rights
Art. 65 Procedure for Dealing with AI Systems Presenting a Risk at National Level
Art. 65a Procedure for Dealing with AI Systems Classified by the Provider as a Not High-Risk in Application of Annex III
Art. 66 Union Safeguard Procedure
Art. 67 Compliant AI Systems Which Present a Risk
Art. 68 Formal Non-Compliance
Art. 68a Union Testing Facilities in the Area of Artificial Intelligence
Chapter 3b: Remedies
Art. 68b Right to Lodge a Complaint with a Market Surveillance Authority
Art. 68c A Right to Explanation of Individual Decision-Making
Art. 68d Amendment to Directive (EU) 2020/1828
Art. 68e Reporting of Breaches and Protection of Reporting Persons
Chapter 3c: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General Purpose AI Models
Art. 68f Enforcement of Obligations on Providers of General Purpose AI Models
Art. 68g Monitoring Actions
Art. 68h Alerts of Systemic Risks by the Scientific Panel
Art. 68i Power to Request Documentation and Information
Art. 68j Power to Conduct Evaluations
Art. 68k Power to Request Measures
Art. 68m Procedural Rights of Economic Operators of the General Purpose AI Model
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 Penalties
Art. 72 Administrative Fines on Union Institutions, Agencies and Bodies
Art. 72a Fines for Providers of General Purpose AI Models
Title XI: Delegation of Power and Committee Procedure
Art. 73 Exercise of the Delegation
Art. 74 Committee Procedure
Title XII: Final Provisions
Art. 75 Amendment to Regulation (EC) No 300/2008
Art. 76 Amendment to Regulation (EU) No 167/2013
Art. 77 Amendment to Regulation (EU) No 168/2013
Art. 78 Amendment to Directive 2014/90/EU
Art. 79 Amendment to Directive (EU) 2016/797
Art. 80 Amendment to Regulation (EU) 2018/858
Art. 81 Amendment to Regulation (EU) 2018/1139
Art. 82 Amendment to Regulation (EU) 2019/2144
Art. 82a Guidelines from the Commission on the Implementation of this Regulation
Art. 83 AI Systems Already Placed on the Market or Put into Service
Art. 84 Evaluation and Review
Art. 85 Entry into Force and Application
Privacy Policy | Liability
Title VII
EU Database for High-Risk AI Systems Listed in Annex III
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Art. 60 EU Database for High-Risk AI Systems Listed in Annex III
Title I
Title IA
Title II
Title III
Title IV
Title VIIIa
Title V
Title VI
Title VII
Title VIII
Title IX
Title X
Title XI
Title XII
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Art. 60 EU Database for High-Risk AI Systems Listed in Annex III