What EU AI Act Annex II - Union Harmonisation Legislation for Products in High-Risk AI Classification requires
EU AI Act Regulation 2024/1689 Annex II lists the Union harmonisation legislation applicable to safety-regulated products whose embedded AI components are automatically classified as high-risk under Article 6(1) - an AI system that is a safety component of, or itself constitutes, a product regulated by any of the listed sectoral instruments is subject to the full Chapter III high-risk AI system obligations; the Annex II list covers eleven product safety sectors including medical devices (MDR 2017/745, IVDR 2017/746), machinery (Regulation 2023/1230), radio equipment (RED 2014/53), civil aviation, marine equipment, railway interoperability, agricultural vehicles, and pressure equipment; providers of AI-embedded regulated products must satisfy both the Annex II sectoral legislation conformity requirements and the EU AI Act Chapter III requirements, with harmonised conformity assessment procedures available under Article 43(4).
Pillar: AI Governance & Law · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689
SHA-256 integrity: b868f159b8ab38640955864d2c4f7f1630a27b13a7d11e2d76844d07b5e102dc
Primary Citations — 5 traced to source
- Regulation (EU) 2024/1689 - Annex II: List of Union Harmonisation Legislation
- Regulation (EU) 2024/1689 - Article 6(1): Classification of AI Systems as High-Risk Based on Annex II
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