In July 2026, the Medical Device Coordination Group (MDCG) published MDCG 2026-5 – Position Paper on UDI Assignment Between Manufacturers and Distributors. This position paper aims to ensure consistent application of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) regarding Unique Device Identification (UDI) assignment and registration in EUDAMED.
Distributors assigning UDI-DIs: two UDI-DIs for the same device?
According to the MDCG paper, some companies consider it compliant with the MDR or IVDR that the assignment of the UDI is performed by the distributor who makes devices available on the EU market under its own name, while maintaining the manufacturer’s indication on the label. In such cases, the distributor receives an alphanumeric code which is linked to the distributor as well as to the device of the manufacturer. This also means that within the Basic UDI-DI, the manufacturer lists two groups of UDI-DIs in EUDAMED:
- the UDI-DIs that the manufacturer has assigned to the device marketed under its own brand; and
- the UDI-DIs assigned by the distributor who markets the same device but under its own brand, while keeping the manufacturer’s indication on the label.
Key clarification: only manufacturers may assign UDI-DIs
The conclusion of MDCG 2026-5 is that only the manufacturer may assign UDI-DIs to devices intended to be placed on the EU market. Specifically, the position paper points out that “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.”
In addition, the MDCG clarifies the following points:
- While it is correct to have two different UDI-DIs under two brand names, both brand-names should be linked only to the manufacturer both in EUDAMED and in the databases or internal documents of the UDI issuing entities.
- The UDI issuing entities should ensure that the entity to which they provide and link the UDI-DI codes is the manufacturer.
- The manufacturer may potentially delegate the practical operation of UDI assignment to a third party (e.g. under a contractual agreement), but the manufacturer remains the legally liable for complying with UDI obligations.
For any questions on compliance with the MDR and IVDR, contact us here or at mdlaw@obelis.net.
For MDlaw members: Guidance on UDI carrier obligation: requirements, implementation, exceptions
Leave a Reply