EU MDR
EU Medical Device Regulation (2017/745) · mdr · regulation 2017/745
EU regulation that replaced the MDD in May 2021 — stricter clinical evidence, expanded scope (includes aesthetic devices), UDI, EUDAMED, mandatory PMS and PSUR.
Regulation (EU) 2017/745 (MDR) replaced the Medical Device Directive (93/42/EEC). Key changes: stricter clinical evaluation, UDI, EUDAMED database, expanded scope to certain aesthetic products, Person Responsible for Regulatory Compliance (PRRC), reclassification of many devices upward, mandatory post-market surveillance and PSUR / PMCF for higher-risk classes.
CE marking under MDR requires conformity assessment by a Notified Body (except Class I). V5's medical-device profile supports both 21 CFR 820 / QMSR and ISO 13485 / MDR evidence simultaneously — one set of records, two regulatory regimes.
- Regulation (EU) 2017/745
Free trial, no credit card, onboard in days, not months.