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:
Primary source: https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
SHA-256 integrity: 30f5a6f28a8f3d0d735b4e178bd11c1ac75ebf6335cb15e0e6b78328296fcf57
Primary Citations — 5 traced to source
- {"title":"EU Medical Devices Regulation 2017/745","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745"}
- {"title":"European Commission MDR Guidance Documents","url":"https://ec.europa.eu/health/md_sector/new_regulations/guidance_en"}
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