Article 63: Derogations for Specific Operators
Summary of Article 63 * Simplified Compliance for Microenterprises: Microenterprises without partner or linked enterprises may adhere to simplified quality management
Article 64: AI Office
1. The Commission shall develop Union expertise and capabilities in the field of AI through the AI Office. 2. Member
Article 65: Establishment and Structure of the European Artificial Intelligence Board
Summary of Article 65 * Structure of the European AI Board: The European Artificial Intelligence Board is established with representatives from
Article 66: Tasks of the Board
Summary of Article 66 * Board’s Role in Coordination and Expertise: The Board coordinates national authorities, shares expertise, harmonises practices,
Article 67: Advisory Forum
Summary of Article 67 * Advisory Forum Structure and Membership: The advisory forum is established to provide technical expertise, with a
Article 68: Scientific Panel of Independent Experts
Summary of Article 68 * Scientific Panel Membership: The Commission establishes the scientific panel of independent AI experts to support enforcement
Article 69: Access to the Pool of Experts by the Member States
Summary of Article 69 * Expert Support for Member States: Member States may utilize experts from the scientific panel for enforcement
Article 70: Designation of National Competent Authorities and Single Point of Contact
Summary of Article 70 * Designation of National Authorities: Member States must designate at least one notifying authority and one market
Article 71: EU Database for High-Risk AI Systems Listed in Annex III
Summary of Article 71 * Commission’s Role in EU Database: The Commission, in collaboration with Member States, shall establish, maintain,
Article 72: Post-Market Monitoring by Providers and Post-Market Monitoring Plan for High-Risk AI Systems
Summary of Article 72 * Provider Responsibilities in Post-Market Monitoring: Providers must establish and maintain a documented post-market monitoring system to
Article 73: Reporting of Serious Incidents
Summary of Article 73 * Provider Responsibilities in Serious Incident Reporting: Providers must report serious incidents linked to high-risk AI systems
Article 74: Market Surveillance and Control of AI Systems in the Union Market
Summary of Article 74 * Application of Existing EU Regulations: Regulation (EU) 2019/1020 applies to AI systems under this Regulation,
Article 75: Mutual Assistance, Market Surveillance and Control of General-Purpose AI Systems
Summary of Article 75 * AI Office’s Monitoring Role: The AI Office monitors compliance of AI systems using general-purpose models,
Article 76: Supervision of Testing in Real World Conditions by Market Surveillance Authorities
Summary of Article 76 * Market Surveillance Role in Testing Oversight: Market surveillance authorities ensure compliance of real-world testing with regulatory
Article 77: Powers of Authorities Protecting Fundamental Rights
Summary of Article 77 * Role of Public Authorities in Monitoring High-Risk AI Systems: National public authorities responsible for fundamental rights
Article 78: Confidentiality
Summary of Article 78 * Confidentiality Obligations for Authorities and Entities: The Commission, market surveillance authorities, and other entities involved must
Article 79: Procedure at National Level for Dealing with AI Systems Presenting a Risk
Summary of Article 79 * Risk Assessment and Compliance Duties of Authorities: Market surveillance authorities must evaluate AI systems presenting risks
Article 80: Procedure for Dealing with AI Systems Classified by the Provider as Non-High-Risk in Application of Annex III
Summary of Article 80 * Market Surveillance Authority’s Role in Reclassifying AI Systems: Market surveillance authorities evaluate AI systems classified
Article 81: Union Safeguard Procedure
Summary of Article 81 * Commission’s Role in Evaluating National Measures: The Commission evaluates objections or concerns raised by Member
Article 82: Compliant AI Systems Which Present a Risk
Summary of Article 82 * Corrective Actions by Authorities: Market surveillance authorities can mandate operators to implement corrective measures if a
Article 83: Formal Non-Compliance
Summary of Article 83 * Identification of Non-Compliance: Authorities must require providers to resolve non-compliance issues related to CE marking, declarations
Article 84: Union AI Testing Support Structures
1. The Commission shall designate one or more Union AI testing support structures to perform the tasks listed under Article
Article 85: Right to Lodge a Complaint with a Market Surveillance Authority
Without prejudice to other administrative or judicial remedies, any natural or legal person having grounds to consider that there has
Article 86: Right to Explanation of Individual Decision-Making
Summary of Article 86 * Deployers’ Obligation to Provide Explanations: Deployers must provide affected individuals with clear and meaningful explanations of
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