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類別: REGULATORY PATHWAYS
CE標誌
在歐洲經濟區銷售醫療器材所需的合格標誌。CE標誌表明器材滿足適用的EU指令或法規（EU MDR或IVDR）的基本要求。
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
CE marking is required to place most medical devices on the EU market under MDR/IVDR, signaling conformity with applicable Union legislation.
PROCESS / STEPS
- Classify device and choose conformity assessment route.
- Implement QMS and compile technical documentation + clinical evaluation.
- Involve a Notified Body when required; obtain certificate(s).
- Draw up EU Declaration of Conformity and affix CE mark (with NB number if applicable).
- Fulfill post-market and economic-operator obligations ongoing.
EXAMPLES
- Class I non-sterile non-measuring devices may self-declare; higher classes need NB review.
RELATED GUIDES & TOOLS
SOURCES
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