MDCG 2026-5: Only Manufacturers May Assign a UDI ⚕️ Pure Clinical

MDCG settles the UDI dispute: who is actually allowed to assign a code to a distributor?

In July 2026, the Medical Device Coordination Group (MDCG) published Position Paper MDCG 2026-5, resolving a growing interpretive dispute over the assignment of Unique Device Identifiers (UDI). A practice whereby distributors independently obtained their own UDI-DI codes under their own brand has now been unambiguously declared non-compliant with the MDR and IVDR — only the manufacturer is entitled to assign a UDI.

Where did the problem of UDi for distributors come from?

MDCG observed that certain distributors placing devices on the market under their own trade name — while keeping the manufacturer’s details on the label, as permitted under Article 16(1)(a) MDR/IVDR — had started obtaining alphanumeric codes directly from EU UDI issuing entities. As a result, the same device ended up registered in Eudamed under two different UDI-DIs: one correctly linked to the manufacturer, the other mistakenly linked to the distributor.

What do the regulations actually say?

Under Article 27(1)(a)(i) MDR and the corresponding Article 24(1)(a)(i) IVDR, the UDI-DI is specific to a manufacturer and a device. Annex VI, Part C spells this out directly:

point 2.2 – the manufacturer shall assign and maintain unique UDIs for its devices;
point 2.3 – only the manufacturer may place the UDI on the device or its packaging.

MDCG points to the position of the EU UDI Helpdesk, which allows a manufacturer to delegate the practical execution of UDI assignment and application to a third party under a contractual arrangement. That distinction matters for Regulatory Affairs teams: operational outsourcing is lawful, but legal liability for UDI compliance stays with the manufacturer, without exception and regardless of any agreement with the distributor.

What does this mean for the supply chain in practice?

Two different UDI-DIs for the same device marketed under two brands remain permissible, but both must be assigned and registered by the manufacturer, never by the distributor acting in its own name. EU UDI issuing entities are now expected to verify that the entity requesting a code genuinely acts as the manufacturer under the MDR/IVDR before linking that code and the corresponding Eudamed data to it.

What you should do with your UDI codes?

Check whether your distributors are independently requesting UDI-DI codes.
Review distributor agreements against Article 16(1)(a) MDR/IVDR.
Confirm that Eudamed registration is carried out solely by the manufacturer or by a party expressly acting on the manufacturer’s behalf.

Link to the document: https://health.ec.europa.eu/document/download/mdcg_2026-5_en.pdf