The second document related to EUDAMED was published today on the European Commission website. The MDCG discussed registration of a ”legacy” device, i.e. device with a CE Certificate issued under the ”old” Directives that can be placed on the EU market after the MDR application date while respecting certain requirements of the new Regulation, such as post-market surveillance and registration of devices {Transitional provisions stated in Article 120(3) of the MDR}.
The MDCG concluded while taking all views heard into account, and considering that Article 120(3):
-
Refers to legacy devices to be registered in line with MDR provisions,
-
Lacks any explicit reference to UDI obligations for legacy devices
the MDCG considers it appropriate to adapt the Eudamed design to allow the registration of legacy devices in Eudamed in the absence of a (Basic) UDI-DI.
Further technical implications can be found here under the MDCG documents.
Leave a Reply