With the intention of providing clarification concerning which entity should be responsible for seeking and registering UDI-DIs in the EU, the MDCG has published a related Position Paper. The Paper is specifically intended to clarify the role of distributors in acquisition of UDI-DI codes from EU UDI issuing entities.
The Position Paper:
- Underlines that it is the original manufacturer who must seek a UDI-DI from the EU UDI issuing entities designated by Commission Implementing Decision (EU) 2019/939 and must register the number in Eudamed;
- Provides that, where a medical device is marketed under two different brands, each brand must have a separate UDI-DI;
- Provides that, while the manufacturer may delegate the request for the second UDI-DI to the EU distributor, responsibility for seeking and registering the second UDI-DI remains with the manufacturer.
The Position Paper appears to exclude distributors who, on the basis of Article 16 of the MDR and the IVDR, assume the obligations incumbent on manufacturers, from the right to seek and register UDI-DIs.