What EU AI Act and Medical Devices Regulation - Dual Compliance for AI Medical Devices requires
AI systems used as medical devices or embedded in medical devices are subject to dual compliance obligations under Regulation (EU) 2024/1689 (EU AI Act) and Regulation (EU) 2017/745 (Medical Devices Regulation, MDR); the intersection…
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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: 2c6d4ad4ab60f4bdcf0bf008904adeaf02489e9e3c9624da850c18ee3f6a7af5
Primary Citations — 5 traced to source
- Regulation (EU) 2024/1689 - EU AI Act: Article 6(1) and Annex II - Automatic High-Risk Classification for AI Safety Components of MDR Products
- Regulation (EU) 2017/745 - Medical Devices Regulation (MDR): Article 2(1) - Medical Device Definition and SaMD Qualification
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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- Discovery (free): /api/v1/nodes/eu-ai-act-medical-devices-mdr-intersection.json — 6-field metadata
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- Canonical URL: https://bidda.com/intelligence/eu-ai-act-medical-devices-mdr-intersection
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