EUDAMED Services
Actor Registration The Actor Registration Module was the first module to be released (December 2020); the economic operators listed below are Actors and need be registered via EUDAMED: All manufacturers must register with EUDAMED and acquire a Single Registration Number (SRN), non-EU manufacturer’s must indicate who their appointed EU Authorised Representative (EC REP) is when ...
EUDAMED
Introduction The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746) to allow greater transparency and traceability of devices in the European Union (EU). The European database on medical devices ...
