{
  "node_id": "eu-ai-act-annex-ii-union-harmonisation-legislation",
  "title": "EU AI Act Annex II - Union Harmonisation Legislation for Products in High-Risk AI Classification",
  "domain": "AI Governance & Law",
  "version": "1.0.0",
  "last_updated": "2026-04-28",
  "bluf": "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).",
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  "dependencies": [
    "eu-ai-act-2024",
    "eu-ai-act-article-6-classification-high-risk",
    "eu-ai-act-article-9-risk-management-system",
    "eu-ai-act-2024-1689-article-43-conformity-assessment-procedures-high-risk"
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  "primary_citations_count": 5
}