New guidance on UDI assignment for medical devices
The MDCG 2026-5 UDI clarifies the responsibilities relating to the assignment of unique device identifiers for medical devices marketed under a distributor’s brand.
The Medical Device Coordination Group (MDCG) is the European coordinating group for medical devices, established under Article 103 of Regulation (EU) 2017/745 (MDR). It is composed of representatives of the Member States and chaired by a representative of the European Commission. MDCG documents provide guidance to promote the consistent application of European medical-device legislation, although they are not legally binding.
The MDCG 2026-5 document, published in July 2026, specifies that UDI-DIs must be linked to the manufacturer, even when the device is placed on the market under a trade name that differs from the manufacturer’s own name.
This clarification is particularly relevant to private-label and distributor-brand arrangements, in which the distributor markets the device under its own brand while retaining the manufacturer’s details on the label.
UDI assignment under MDCG 2026-5
MDCG 2026-5 addresses a practice found among some distributors: requesting UDI-DI codes directly from an EU-recognised UDI issuing entity in their own name for devices manufactured by another company.
In some cases, this approach had been considered compatible with the arrangements provided for in Article 16(1)(a) of the MDR and IVDR, where the distributor markets the device under its own brand while keeping the manufacturer identified on the label.
The document clarifies that this interpretation is not consistent with the responsibilities established by the UDI system.
UDI-DIs must be linked to the manufacturer
According to MDCG 2026-5, UDI-DIs may be assigned exclusively by the manufacturer. Issuing entities must therefore ensure that the codes are provided to, and linked with, the company acting as the device manufacturer.
The reference is the manufacturer identified on the label and in the product documentation, rather than the entity that owns the device’s trade name.
The document recalls the requirements of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), under which the manufacturer is responsible for assigning and maintaining UDIs and for meeting the registration obligations laid down by the legislation.
Different UDI-DIs for the same device
MDCG 2026-5 recognises that the same device marketed under two different trade names may have two separate UDI-DIs.
The key condition is that both are assigned by, and linked to, the manufacturer, including in the databases of UDI issuing entities and in EUDAMED’s UDI/Device module.
In the case described in the document, the different UDI-DIs are traced back to the same manufacturer, preventing either identifier from being associated with the distributor instead.
Delegating practical UDI-related activities
MDCG clearly distinguishes between legal responsibility and the operational performance of activities.
The manufacturer may entrust a third party, including under a contractual agreement, with practical activities relating to requesting, assigning or applying UDIs.
However, delegation does not transfer legal responsibility. The third party acts on the manufacturer’s behalf, while ultimate responsibility for compliance with UDI obligations remains with the manufacturer.
Checks for manufacturers and distributors
Companies operating under private-label or distributor-brand arrangements should review the management of identifiers already assigned, checking:
- the entity to which the UDI-DIs are linked;
- consistency between the codes, the manufacturer identified on the label and the documentation;
- the information held by UDI issuing entities;
- the registration of devices in EUDAMED;
- contractual arrangements and internal procedures for managing UDIs.
The aim is to identify any discrepancies and define the actions needed to bring the assignment and registration of identifiers into line with the manufacturer’s responsibilities.
UDI alignment: Farmaimpresa’s next steps
Proper UDI management requires identifiers to be consistent with the manufacturer responsible for the device, even when the device is marketed under a distributor’s brand.
Farmaimpresa will directly contact distributors for whom UDI-DIs not aligned with the guidance in MDCG 2026-5 have been identified, in order to coordinate the activities needed to align the identifiers and related documentation with the requirements set out in the document.
Bibliography
- Medical Device Coordination Group (MDCG). MDCG 2026-5 – UDI assignment between manufacturers and distributors. July 2026.
- Pure Global. EU MDCG 2026-5: UDI Assignment Between Manufacturers and Distributors.
- European Parliament and Council of the European Union. Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR). Official Journal of the European Union, L 117, 5 May 2017.
