What EU AI Act - Obligations of Providers of High-Risk AI Systems (Articles 16-20) requires
EU AI Act (Regulation 2024/1689) Articles 16-20 establish the comprehensive obligations of providers - natural or legal persons who develop or have high-risk AI systems developed and place them on the market or put them into service under their own name or trademark - for high-risk AI systems listed in Annex III or covered by Annex I sector-specific legislation; core provider obligations under Articles 16-20 include: Article 16 - establish a quality management system under Article 17; draw up technical documentation under Article 11; ensure the high-risk AI system undergoes the applicable conformity assessment procedure under Articles 43-44; draw up the EU declaration of conformity under Article 47; affix CE marking under Article 48; register the system in the EU database under Article 49; Article 17 - implement a quality management system (QMS) covering: AI system development and testing; data governance; technical documentation procedures; post-market monitoring; risk management; conformity assessment; Article 18 - keep technical documentation for 10 years after placing on the market or putting into service (or for the period the system is in service where longer); Article 19 - cooperate with national competent authorities on all requests; Article 20 - implement automatic logging capabilities enabling re-tracing of AI system operation over a period appropriate to the AI system's purpose; the provider is responsible for compliance of the high-risk AI system throughout its lifecycle, including after sale - post-market monitoring obligations under Article 61 continue after the system has been placed on the market; where a high-risk AI system is embedded in a product covered by Union harmonisation legislation listed in Annex I (e.g., machinery, medical devices, automotive), providers must comply with both the EU AI Act and the applicable sectoral legislation.
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: 7e8b0620b8a27b8cf782927e5d0cf65981032d2cfbe0bcb3ed067982eec557a0
Primary Citations — 5 traced to source
- Regulation (EU) 2024/1689 - EU AI Act: Articles 16-20 - Obligations of Providers of High-Risk AI Systems
- Regulation (EU) 2024/1689 - EU AI Act: Article 17 - Quality Management System
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