EU EUDAMED UDI

The European Commission has implemented the European Database on Medical Devices (EUDAMED) to serve as a centralized database for economic operators (manufacturers worldwide, designated representatives, and system/procedure pack providers). EUDAMED requires device registration and EU regulatory information submission across 6 specific modules. Development has been underway for some time with voluntary activity occurring for the Actor Module and Device/UDI Registration Module. EUDAMED carries some specific differences from US FDA. This in-depth ‘Understanding UDI Series’ will explain unique concepts like Basic UDI-DI (BUDI-DI) and other regulatory nuances.