MDCG Clarifies UDI Assignment Between Manufacturers and Distributors
The MDCG has released new guidance clarifying responsibility for assigning Unique Device Identifiers (UDI-DI) for medical devices, particularly when products are marketed under different brand names.
The Medical Device Coordination Group (MDCG) has published new guidance, MDCG 2026-5, clarifying the assignment process for Unique Device Identifiers (UDI) for medical devices, dated July 22, 2026.
The guidance specifies that only the manufacturers of medical devices are responsible for assigning UDI-DIs. This applies even when a product is sold under various brand names or trademarks.
This clarification aims to resolve ambiguities and ensure compliance with the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The ruling is significant for the medical device supply chain, as it establishes clear accountability for product identification within the European market.