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类别: REGULATORY PATHWAYS
EUDAMED
欧洲医疗器械数据库——EU MDR下的集中IT平台，包含6个模块：参与者注册、UDI/器械注册、证书、临床调查、警戒和市场监督。
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
EUDAMED is the EU database platform under MDR/IVDR for actors, UDI/devices, certificates, clinical investigations, vigilance, and market surveillance modules as they become mandatory.
PROCESS / STEPS
- Register economic operators and obtain SRNs when required.
- Prepare UDI-DI data and device registration packages.
- Align certificate and vigilance submissions with NB and competent authorities.
- Keep records synchronized when device versions or actors change.
EXAMPLES
- Manufacturers register as actors before placing devices under MDR obligations.
RELATED GUIDES & TOOLS
SOURCES
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