EU Medical Devices Regulation 2017/745 - CE Marking, Clinical Evaluation & Post-Market Surveillance

What EU Medical Devices Regulation 2017/745 - CE Marking, Clinical Evaluation & Post-Market Surveillance requires

EU MDR 2017/745 (fully applicable May 2021) replaces MDD/AIMDD with a risk-based classification system (Class I-III), mandatory clinical evaluation, post-market clinical follow-up, and EUDAMED registration for all medical devices placed on the EU market - manufacturers face up to EUR 100 million product liability exposure.

Pillar: Medical & Healthcare · Authority: European Commission - DG SANTE Medical Devices · Version: 2.0 · Last updated: 2026-05-10

Primary source: https://ec.europa.eu/health/md_sector/new_regulations/guidance_en

SHA-256 integrity: 6774e592292b98b91be24e543e85d259a1ef9ba17c71fffb87f477c70edb4dbe

Primary Citations — 5 traced to source

• EU Medical Devices Regulation 2017/745
• European Commission MDR Guidance Documents

+ 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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