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類別: DOCUMENTATION
符合性聲明(DoC)
製造商正式聲明醫療器材滿足所有適用法規要求的文件。根據EU MDR，DoC必須引用法規、公告機構證書和適用的協調標準。
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
The EU Declaration of Conformity is the manufacturer’s formal statement that a device meets MDR/IVDR requirements before CE marking and placing on the market.
PROCESS / STEPS
- Complete conformity assessment route.
- Identify applicable legislation and standards.
- Sign DoC with manufacturer identity and device identifiers.
- Keep DoC updated with certificate scope changes.
EXAMPLES
- Distributors and importers often request the DoC as part of due diligence.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 符合性聲明(DoC) across 27 authorities in real time.
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