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63b
[Deleted]
Removed on 31 July 2024 based on the version published in the Official Journal of the EU dated 12 July 2024 and entered into force on 1 August 2024.
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Article 63a: [Deleted]
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Article 64: AI Office
Table of Contents
Chapter I: General Provisions
Article 1: Subject matter
Article 2: Scope
Article 3: Definitions
Article 4: AI Literacy
Article 4a
Chapter II: Prohibited AI Practices
Article 5: Prohibited AI Practices
Chapter III: High-Risk AI Systems
Section 1: Classification of AI Systems as High-Risk
Article 6: Classification Rules for High-Risk AI Systems
Article 7: Amendments to Annex III
Section 2: Requirements for High-Risk AI Systems
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
Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties
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 23a
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
Section 4: Notifying Authorities and Notified Bodies
Article 28: Notifying Authorities
Article 29: Application of a Conformity Assessment Body for Notification
Article 29a: [Deleted]
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 33a: [Deleted]
Article 34: Operational Obligations of Notified Bodies
Article 34a: [Deleted]
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
Section 5: Standards, Conformity Assessment, Certification, Registration
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
Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Article 50: Transparency Obligations for Providers and Deployers of Certain AI Systems
Chapter V: General-Purpose AI Models
Section 1: Classification Rules
Article 51: Classification of General-Purpose AI Models as General-Purpose AI Models with Systemic Risk
Article 52: Procedure
Article 52a: [Deleted]
Article 52b: [Deleted]
Article 52c: [Deleted]
Article 52ca: [Deleted]
Article 52d: [Deleted]
Article 52e: [Deleted]
Section 2: Obligations for Providers of General Purpose AI Models
Article 53: Obligations for Providers of General-Purpose AI Models
Article 53a: [Deleted]
Article 54: Authorised Representatives of Providers of General-Purpose AI Models
Article 54a: [Deleted]
Article 54b: [Deleted]
Section 3: Obligations for Providers of General Purpose AI Models with Systemic Risk
Article 55: Obligations for Providers of General-Purpose AI Models with Systemic Risk
Article 55a: [Deleted]
Article 55b: [Deleted]
Section 4: Codes of Practice
Article 56: Codes of Practice
Chapter VI: Measures in Support of Innovation
Article 57: AI Regulatory Sandboxes
Article 58: Detailed Arrangements for, and Functioning of, AI Regulatory Sandboxes
Article 58a: [Deleted]
Article 58b: [Deleted]
Article 58c: [Deleted]
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 63a: [Deleted]
Article 63b: [Deleted]
Chapter VII: Governance
Section 1: Governance at Union Level
Article 64: AI Office
Article 65: Establishment and Structure of the European Artificial Intelligence Board
Article 65a: [Deleted]
Article 66: Tasks of the Board
Article 67: Advisory Forum
Article 68: Scientific Panel of Independent Experts
Article 68a: [Deleted]
Article 68b:
Article 68c: [Deleted]
Article 68d:
Article 68e: [Deleted]
Article 68f: [Deleted]
Article 68g: [Deleted]
Article 68h: [Deleted]
Section 2: National Competent Authorities
Article 70: Designation of National Competent Authorities and Single Point of Contact
Chapter VIII: EU Database for High-Risk Systems
Article 71: EU Database for High-Risk AI Systems Listed in Annex III
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance
Section 1: Post-Market Monitoring
Article 72: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
Article 72a: [Deleted]
Section 2: Sharing of Information on Serious Incidents
Article 73: Reporting of Serious Incidents
Section 3: Enforcement
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 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 82a
Article 83: Formal Non-Compliance
Article 84: Union AI Testing Support Structures
Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
Section 4: Remedies
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
Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models
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
Chapter X: Codes of Conduct and Guidelines
Article 95: Codes of Conduct for Voluntary Application of Specific Requirements
Article 96: Guidelines from the Commission on the Implementation of this Regulation
Chapter XI: Delegation of Power and Committee Procedure
Article 97: Exercise of the Delegation
Article 98: Committee Procedure
Chapter XII: Penalties
Article 99: Penalties
Article 100: Administrative Fines on Union Institutions, Bodies, Offices and Agencies
Article 101: Fines for Providers of General-Purpose AI Models
Chapter XIII: Final Provisions
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: Amendment 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
