What EU MDR Annex XVI - Products Without Intended Medical Purpose requires
Requirements for aesthetic devices, wellness products, and other non-medical purpose items that fall under MDR scope. 2026 clarifications address AI-enabled wellness tools and common specifications.
Pillar: Medical & Healthcare · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
SHA-256 integrity: ecea840f8f376a0d32f4e6ee30c8b15b32f88b3a38cca571cefd53779a940def
Primary Citations — 5 traced to source
- Regulation (EU) 2017/745 on medical devices, Article 1.
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Article 1.
+ 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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