Is Basic UDI-DI needed for ‘legacy’ devices?
A Basic UDI-DI is not required for devices CE marked under the old Directives
– it is only mandatory for MDR/IVDR CE marked devices.
However, that doesn’t mean that ‘legacy’ device
manufacturers are completely exempt from this requirement. For the purposes of registering in EUDAMED, legacy devices will require a EUDAMED DI, which will perform a similar function as the Basic UDI-DI.
Where a legacy device manufacturer has a UDI system in place and UDI-DI applied for its devices, EUDAMED will auto-generate a EUDAMED DI when they register. Where a legacy device manufacturer does not yet have a UDI system in place, because UDI is not mandatory under the old Directives, then one will need to be created independent from a UDI-DI. This is called the EUDAMED ID.
The below is from the EU Commission’s User Guide:
“EUDAMED DI
The EUDAMED DI corresponds to the Basic UDI-DI. It can either be entirely generated by EUDAMED if a UDI-DI has already been assigned to the legacy device, or the DI code can be partly assigned by the manufacturer (EUDAMED is the issuing entity for a EUDAMED DI)
EUDAMED ID
The EUDAMED ID corresponds to the UDI-DI. In case an UDI-DI has not already been assigned, the EUDAMED ID will always be automatically and fully generated by EUDAMED from the EUDAMED DI.”
It can be somewhat of a confusing concept. But essentially, legacy devices will either have a EUDAMED DI or a EUDAMED ID, depending on if the manufacturer has a UDI system in place yet or not. Both the EUDAMED DI and EUDAMED ID are created within the EUDAMED database.
Further, the EUDAMED DI / EUDAMED ID is not required to be listed in the device’s technical file, Declaration of Conformity, nor added to your MDD/AIMDD/IVDD CE Certificates. However, manufacturers may include the EUDAMED DI / EUDAMED ID to some technical documentation or procedures, as necessary for device traceability.
A final note on this topic is that EUDAMED is currently voluntary. Read more about registration requirements and timing on our EUDAMED Basics page.