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类别: DOCUMENTATION
符合性声明(DoC)
制造商正式声明医疗器械满足所有适用法规要求的文件。根据EU MDR，DoC必须引用法规、公告机构证书和适用的协调标准。
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
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