What EU AI Act - Post-Market Surveillance, Monitoring, and Incident Reporting (Articles 61-62) requires
EU AI Act (Regulation 2024/1689) Articles 61 and 62 establish the post-market surveillance and serious incident reporting framework applicable to high-risk AI system providers - Article 61 requires providers to actively collect and review data on performance of their high-risk AI systems throughout the lifecycle, with a post-market monitoring plan documented in the technical documentation; Article 62 requires providers to report to national market surveillance authorities any serious incident or malfunctioning of a high-risk AI system that constitutes a breach of obligations under applicable EU law or that constitutes a risk to health and safety; the post-market surveillance framework mirrors the post-market surveillance obligations under EU medical device regulation (MDR - Regulation 2017/745) and product safety regulation, reflecting the EU AI Act's roots in the New Legislative Framework; the market surveillance authority receiving an Article 62 incident report must communicate it to other Member State authorities through the RAPEX-equivalent AI incident notification system; GPAI providers with systemic risk must implement additional post-deployment monitoring measures under Article 55(1)(d) covering training compute, testing results, adversarial testing findings, and capability evaluations - creating a more intensive monitoring regime than standard high-risk AI post-market surveillance.
Pillar: AI Governance & Law · Authority: European Parliament and Council of the EU · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689
SHA-256 integrity: 6cca300c8e124b221e82cca27f90fe8565ff0e3e6cb1e776b21cd5aa1e1516d8
Primary Citations — 5 traced to source
- Regulation (EU) 2024/1689 - EU AI Act: Article 61 - Post-Market Monitoring of High-Risk AI Systems
- Regulation (EU) 2024/1689 - EU AI Act: Article 73 - Reporting of Serious Incidents by High-Risk AI System Providers
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