UDI Registration in EUDAMED — Why and How to use It now

The European Database on Medical Devices (EUDAMED) Device Registration and UDI Database module is available for use since October 4th. No longer a sandbox, device manufacturers can enter Basic Unique Device Identification Device Identifier (Basic UDI-DI) and UDI-DI information into EUDAMED using real data.

According to the European Commission, this is a Minimum Viable Product (MVP), so additional functionality will be added later, but it does allow full registration of devices. Still, there are issues to be aware of and concerns about how this module will (or will not) evolve as we advance toward a fully functional EUDAMED.