EUDAMED
Short definition
EUDAMED is the European database on medical devices, laid down in Article 33 of Regulation (EU) 2017/745, which brings together information on economic operators, devices, certificates, vigilance and market surveillance.
In plain language
It is organised into modules, including actor registration, UDI and device registration, notified bodies and certificates, clinical investigations, vigilance and market surveillance. Use of the first four available modules (actors, UDI and devices, notified bodies and certificates, market surveillance) became mandatory on 28 May 2026, with transition periods. It aims to increase the transparency and traceability of devices on the European market.
In practice, in an RVer session
RVer's EUDAMED registration has been submitted and is awaiting approval.