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類別: REGULATORY PATHWAYS
EU MDR (法規2017/745)
取代醫療器材指令（MDD）的歐盟醫療器材法規。EU MDR對臨床證據、上市後監管、UDI和EUDAMED註冊提出了更嚴格的要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
EU MDR (Regulation (EU) 2017/745) applies to medical devices placed on the EU/EEA market (and often UK dual strategy planning). It replaces MDD for devices and raises clinical, PMS, UDI, and economic-operator duties.
PROCESS / STEPS
- Classify the device under MDR Annex VIII (rules-based).
- Select conformity assessment route and engage a Notified Body when required (most IIa+).
- Build technical documentation (Annex II/III), GSPR checklist, clinical evaluation (CER), and risk file.
- Implement QMS (typically ISO 13485) and PMS/PMCF plans proportionate to class.
- Register actors and devices in EUDAMED modules as they become mandatory; maintain UDI and certificates.
EXAMPLES
- A Class I sterile device needs NB involvement for sterile aspects even if base Class I is self-declared.
- Implantable Class III devices need deep clinical evidence and SSCP publication expectations.
COMMON MISTAKES
- Assuming MDD certificates last indefinitely—transition windows are class-dependent.
- Treating PMCF as optional paperwork rather than a live surveillance system.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to EU MDR (法規2017/745) across 27 authorities in real time.
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