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类别: REGULATORY PATHWAYS
合格评定
制造商证明医疗器械满足适用法规要求的过程。在欧盟，IIa类及以上器械的合格评定涉及公告机构审查，最终颁发CE证书。
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
Conformity assessment is how manufacturers demonstrate devices meet applicable rules—self-declaration for some low-risk devices, third-party NB assessment for higher risk in the EU, and analogous FDA premarket paths in the US.
PROCESS / STEPS
- Determine device class and legal route.
- Compile evidence and QMS proof.
- Engage NB/FDA/authority as required.
- Issue DoC / obtain clearance/approval/certificate.
EXAMPLES
- EU Class III implants use the most demanding NB conformity assessment routes.
RELATED GUIDES & TOOLS
SOURCES
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