New MDCG Position Paper 2026-5 on UDI Assignment

The MDCG has published a new position paper clarifying the assignment of Unique Device Identifiers (UDI-DI) between manufacturers and distributors under the MDR and IVDR.

Key takeaways:

• Only the manufacturer can assign UDI-DIs and register devices in EUDAMED;
• Devices marketed under different brand names may have different UDI-DIs, but these must remain linked to the manufacturer;
• Distributors may support operational UDI activities, but legal responsibility remains with the manufacturer.

This paper aims to provide clarification on UDI assignment and the associated responsibilities.

DOWNLOAD THE POSITION PAPER MDCG 2026-5