The Impact of Increased Transparency and Traceability Resulting from Eudamed and the Introduction of UDI

The European Database for Medical Devices, Eudamed, will be the backbone for the management of the continuous demonstration of compliance during the life time of devices. Economic operators will have to enter their own data and are required to keep these up to date. Eudamed will combine six databases: Economic Operators, Devices, Notified Bodies & Certificates, Clinical Studies & Performance Studies, Vigilance & PMS, Market Surveillance. Part of Eudamed will be open to the public.

The Unique Device Identifier, UDI, will be introduced as part of the MDR. UDI will make unambiguous identification of a device possible. There are two levels of UDI; the UDI-DI, which identifies the device and UDI-PI, the production identifier. Starting in 2021 with Class III devices and ending in 2025 with Class I devices, UDI must be made available on the label of the device.