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: 4e3254dcedd9ff2d0fb3142506579fbe0c3c0ddc6c5116f733f437fc6650404d
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
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/eu-ai-act-annex-ii-union-harmonisation-legislation.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/eu-ai-act-annex-ii-union-harmonisation-legislation.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/eu-ai-act-annex-ii-union-harmonisation-legislation
- Back to registry: Browse all 10,108 compliance nodes