What EU Medical Devices Regulation 2017/745 (MDR) - Conformity Assessment and CE Marking requires
Regulation (EU) 2017/745 (MDR) replaced Directive 93/42/EEC from May 2021, establishing enhanced conformity assessment requirements for medical devices placed on the EU market. Higher-risk devices (Class IIa, IIb, Class III, implantables) require involvement of a Notified Body for CE marking. Manufacturers must implement a Quality Management System (ISO 13485), conduct clinical evaluations, establish post-market surveillance, and register in EUDAMED. Unique Device Identification (UDI) is mandatory for all classes.
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: 7fc549d2db94d6046614ad4fd05ec682c220425f51d349a507b7f01488b56834
Primary Citations — 5 traced to source
- {"title":"Regulation (EU) 2017/745 - Medical Devices Regulation (MDR)","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745","section":"Annex VIII (classification), Annex IX-XI (conformity), Article 83 (post-market surveillance), Article 87 (serious incidents)"}
- {"title":"MDCG 2022-2 rev 1 - Guidance on general principles of clinical evidence for MDR","url":"https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-guidance-documents_en","section":"Clinical evaluation requirements under MDR"}
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