This Standard Operating Procedure (SOP) provides medical device manufacturers with a clear, step-by-step framework for assigning Unique Device Identifiers (UDIs) and completing device registration in EUDAMED — the European Union's centralized database for medical devices.
The Unique Device Identification (UDI) system enables clear and unambiguous identification of specific medical devices on the market, making traceability easier, improving post-market surveillance, and increasing device safety. As of May 28, 2026, the UDI/Devices module in EUDAMED is mandatory for all manufacturers placing devices on the EU market
This Standard Operating Procedure (SOP) provides medical device manufacturers with a clear, step-by-step framework for assigning Unique Device Identifiers (UDIs) and completing device registration in EUDAMED — the European Union's centralized database for medical devices.
The Unique Device Identification (UDI) system enables clear and unambiguous identification of specific medical devices on the market, making traceability easier, improving post-market surveillance, and increasing device safety. As of May 28, 2026, the UDI/Devices module in EUDAMED is mandatory for all manufacturers placing devices on the EU market
