The Medical Device Coordination Group (MDCG) has published a new position paper addressing the assignment of Unique Device Identifiers (UDIs) between manufacturers and distributors.
The position paper was issued in response to a common practice whereby distributors assign their own Basic UDI-DIs and UDI-DIs under their own brand name and obtain these identifiers directly from an EU-designated UDI issuing entity. While it is permissible for the same device to have different UDI-DIs under different brand names, these identifiers must remain linked to the original manufacturer. This linkage must be maintained both in the UDI/Device Registration Module of the European Database on Medical Devices (EUDAMED) and in the databases or internal records of the relevant EU UDI issuing entities.
The purpose of this MDCG position paper is to clarify the correct application of the MDR UDI requirements, eliminate potential confusion or differing interpretations among manufacturers, distributors, and UDI issuing entities, and prevent the misuse of UDI assignments. Ultimately, the guidance aims to promote consistency, transparency, and harmonized enforcement of the UDI provisions under the Medical Device Regulation across all EU Member States, while ensuring the correct operation of EUDAMED.
The position paper can be accessed using the following link
