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Article 64
AI Office
Updated 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.
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office.
2. Member States shall facilitate the tasks entrusted to the AI Office, as reflected in this Regulation.
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Article 63b: [Deleted]
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Article 65: Establishment and Structure of the European Artificial Intelligence Board
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