EUDAMED

The European medical devices database — UDI, manufacturers, incidents.

Definition

EUDAMED covers 6 modules: Actors registration, UDI/Devices, Notified Bodies and certificates, Clinical investigations, Vigilance, Market surveillance. Mandated by MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). Actor and UDI modules mandatory since 2021.

Origin

First version EUDAMED 1 in 2011. EUDAMED 2 (complete redesign) deploying since 2020.

Example in context

A French wound dressing manufacturer registering a new UDI-DI for a class IIa device.

Related terms

• GS1 ID Key — family to which UDI-DI belongs.