GTIN and UDI Caught in the Trap of Distribution Branding

The use of GTIN codes and the UDI system for labeling medical devices was intended to provide complete traceability. In practice, however, a gray area prevailed for years, during which large distributors assigned their own UDI-DI codes through issuing entities, and confusion in the supply chain soon followed. The long-awaited MDCG 2026-5 document, in conjunction with Annex VI of the MDR, finally puts an end to the speculation. Who is legally responsible for assigning UDIs, what obligations apply to repackagers under Article 16, and where do we encounter unresolved legislative pitfalls when downsizing packaging?

In the past, it was common practice to operate in a “gray area,” where distributors selling medical devices under their own brand would request GTIN/UDI-DI codes from issuing entities (e.g., GS1). They based this practice on agreements with manufacturers under Article 16(1)(a) of the MDR. As a result, the Eudamed database could contain different codes for a single product, some linked to the distributor and others to the manufacturer, which led to confusion.

The MDCG 2026-5 Position Paper, in accordance with Article 10(7), Article 27, and Annex VI, Part C, puts an end to this practice. The UDI-DI code is specific to the manufacturer and the device. Only the manufacturer is authorized to assign the code, obtain it from the issuing entity, and register it in Eudamed. The manufacturer may delegate these operational tasks, but legal responsibility and the link in the databases remain solely with the manufacturer.

For distributors, this means the end of maintaining their own UDI-DI codes. All branded variants must be registered in Eudamed and in the issuing entity’s database and linked directly to the legal manufacturer.

The Pitfall of Downsizing Packaging

When distributors repackage or relabel products under the regime set forth in Article 16(2) of the MDR, the original manufacturer’s GTIN/UDI-DI remains on the packaging unless the distributor assumes the role of the manufacturer. The repackager then adds its own identification details and, for traceability purposes (pursuant to Article 25 of the MDR), maintains a record of the original UDI. However, a major problem arises when the package size is reduced.

If a distributor reduces the package size under Article 16(2)(b) (e.g., by repackaging a box of 100 units into packages of 10 units), they encounter a legislative pitfall. According to Annex VI, Part C, Section 3.9(f) of the MDR, any change in the quantity per package requires a new UDI-DI. However, the repackager is not the legal manufacturer and therefore is not permitted to assign a new UDI-DI. This creates a stalemate: the original UDI-DI on the smaller package misleadingly refers to the original number of units in Eudamed, while the law prohibits the repackager from creating a new code.

This paradox in the UDI system demonstrates that the legislation does not yet cover all market scenarios. For such activities, it is therefore essential to apply robust risk management processes, carefully document every step, and consult the relevant notified body regarding procedures in advance.

Author: Markéta Hrubá