MDCG: Only manufacturers should assign UDI-DIs
The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better standardized as they are added to Europe's new clinical trial database the European Database on Medical Devices (Eudamed).
MDCG published a position paper on 22 July stating that, while it is common practice for distributors to assign their own UDI-DIs to reflect their brand name using codes issued by the relevant issuing entity, the agency said the manufacturer and distributor codes should be linked only to the manufacturer. The codes should match those in the UDI/Device registration module of Eudamed and those used by the EU UDI issuing entities.
"This MDCG Position Paper aims at explaining the point to clarify the situation and avoid confusion, misunderstandings or potential misuse arising from differing interpretations between manufacturers and distributors, as well as the EU UDI issuing entities," said MDCG. "This should ensure clarity, transparency and consistency across EU Member States in their enforcement of the provisions of the EU Medical Device Regulations on UDI and the operation of Eudamed."
The EU's Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) state that UDIs should be identifiable and traceable, except for custom-made devices, investigational devices, or devices used for performance studies. While some distributors argue that they are compliant with the regulations because they have an agreement with the manufacturer to have UDIs under their own name while maintaining the manufacturer's indication on the label, it means that the manufacturer ends up listing two groups of UDI-DIs and registers all of them in Eudamed, leading to the same device having different UDI-DIs in the database.
MDCG said that while it's okay to assign two different UDI-DI codes to the same device available under two different trade names, those codes must be assigned by the manufacturer alone and European UDI issuing entities should ensure that they assign the codes only to the manufacturer.
"The manufacturer, as indicated on the label of the device and the device documentation, is the only entity which can assign UDIs to the device intended to be placed on the EU market (and receive codes from the EU UDI issuing entities, being the codes linked to the manufacturer) and the only entity which can register the device in Eudamed," said MDCG.
The agency also said that, however, it doesn't mean third parties can't interact with UDI assigning entities on behalf of the manufacturer.
