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CATEGORY: REGULATORY PATHWAYS
EUDAMED
The European Database on Medical Devices — a centralized IT platform under EU MDR with 6 modules covering actor registration, UDI/device registration, certificates, clinical investigations, vigilance, and market surveillance.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to EUDAMED across 27 authorities in real time.
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