MDCG Publishes Position Paper on UDI Assignment Between Manufacturers and Distributors
The Medical Device Coordination Group has published MDCG 2026-5, a position paper on UDI assignment between manufacturers and distributors, dated July 2026.
The document addresses a common practice in which distributors assign their own UDI-DIs under their own brand name and obtain UDI-DI codes from EU UDI issuing entities.
MDCG clarifies that, although two different UDI-DIs may be appropriate when the same device is made available under two different trade names, the UDI assignment must be made solely by the manufacturer.
Background
The position paper explains that confusion may arise where distributors market a device under their own brand while maintaining the manufacturer’s indication on the label.
In such cases, the distributor may obtain an alphanumeric code from an EU UDI issuing entity, resulting in a UDI-DI linked to the distributor and to a device manufactured by another company.
MDCG notes that this may create inconsistencies in EUDAMED and in the databases or internal documents of EU UDI issuing entities.
Regulatory Framework
The paper refers to relevant provisions of both the MDR and the IVDR.
Under these Regulations, manufacturers must comply with UDI obligations and registration obligations. The UDI system includes a UDI-DI specific to a manufacturer and a device, and the manufacturer must assign and maintain unique UDIs for its devices.
The document also highlights that only the manufacturer may place the UDI on the device or its packaging.
MDCG Position
MDCG concludes that EU UDI issuing entities should ensure that the entity receiving and being linked to UDI-DI codes is the company acting as the manufacturer.
The position paper clarifies that the manufacturer may delegate the practical operation of UDI assignment or application to a third party under a contractual arrangement. However, the ultimate legal liability for complying with UDI obligations remains with the manufacturer.
MDCG further states that authorised representatives, distributors and importers cannot assign UDIs to devices.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, MDCG 2026-5 reinforces the need to maintain control over UDI assignment and EUDAMED registration.
Manufacturers and distributors should pay particular attention to:
correct assignment of UDI-DIs;
brand-name scenarios involving distributors;
linkage of UDI-DI codes to the manufacturer;
EUDAMED device registration;
contractual arrangements with third parties;
distinction between practical delegation and legal responsibility;
alignment with MDR and IVDR UDI obligations.
For manufacturers, the position paper confirms that UDI responsibilities cannot be transferred to distributors, importers or authorised representatives, even where those actors support practical UDI-related activities.
