Legacy devices

• 115
• admin
• 2023-3-22

In order to facilitate the transition to the new system, the new Regulations give manufacturers the possibility to place products on the market after the general application dates of the new Regulations (and until 26 May 2024 at the latest) by virtue of valid Directive certificates.

These legacy devices are not subject to UDI obligations but they should be registered in the EUDAMED database. More information on the operational aspects of the registration of legacy devices is available at the MDCG 2019-5 guidance document.

Legacy devices that will be registered in EUDAMED will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED.

For this purpose, a EUDAMED DI will be assigned to the device instead of the Basic UDI-DI, and a EUDAMED ID will be assigned by EUDAMED instead of the UDI-DI allowing the system to work and to keep the design of EUDAMED as close as possible to the MDR design. These EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

The EUDAMED DI could be either entirely generated by EUDAMED or the manufacturer could partly assign the DI code. On the other hand, the EUDAMED ID will be always automatically and fully generated by EUDAMED.

More information: