On July 22, 2026, the Medical Device Coordination Group (MDCG) published the guidance document “UDI assignment between manufacturers and distributors”, providing clarification on the increasingly common practice of distributors applying for and registering UDI-DIs in EUDAMED under their own brand names.
This document sets out the regulatory position on who should assign UDI in distributor private-label scenarios. It comes against the backdrop of the mandatory use of the four EUDAMED modules from May 28, 2026, meaning that UDI data now carries legal significance within the regulatory framework.
1. What “Grey-Area Practice” Does the Guidance Address?
A common practice in the industry is as follows:
A distributor enters into an agreement with the manufacturer under MDR Article 16(1)(a), sells the device under its own brand, while retaining the original manufacturer as the “Manufacturer” on the label. However, the distributor independently applies for a UDI-DI from an issuing entity such as GS1 or HIBCC, registers the UDI-DI under its own name, and then asks the manufacturer to enter both UDI-DIs—the original manufacturer’s UDI-DI and the distributor’s brand UDI-DI—into EUDAMED.
According to MDCG, this practice may result in:
- Breaks in the traceability chain, making it difficult to quickly identify the legal manufacturer;
- Confusion regarding EUDAMED as the “single source of truth”;
- Dilution of the manufacturer’s regulatory responsibilities; and
- Potential circumvention of UDI obligations.
2. Three Clear “Manufacturer-Only” Conclusions
Based on MDR Articles 10(7) and 27, IVDR Articles 10(6) and 24, and Annex VI, the conclusions are clear:
1. Exclusive UDI Assignment Right
Only the legal manufacturer identified on the device label may assign a UDI-DI, including the Basic UDI-DI, to a device placed on the EU market.
Distributors, importers and Authorized Representatives do not have this right.
2. Only Manufacturers May Obtain UDI-DIs from Issuing Entities
A UDI-DI must be issued by an issuing entity to the manufacturer and linked to that manufacturer.
Issuing entities are required to verify the identity of the relevant entity and therefore cannot issue the UDI-DI to a distributor acting merely as a distributor.
3. Only Manufacturers May Register UDI-DIs in EUDAMED
The creation, registration and maintenance of UDI-DI information in EUDAMED must be carried out under the manufacturer’s SRN.
3. Is It Compliant to Have Multiple Brands?
If the same device is marketed under both the original manufacturer’s brand and a distributor’s brand, two UDI-DIs may be used.
However, both UDI-DIs must be assigned by the manufacturer and linked to the manufacturer, under the same Basic UDI-DI.
In other words:
Two brands ≠ two UDI owners.
The distributor’s private label does not, by itself, give the distributor the right to independently assign a UDI-DI.
4. What Can Distributors Do? “Delegation of Operations Does Not Transfer Legal Responsibility”
According to the position of the EU UDI Helpdesk, MDR and IVDR define the legal responsibilities of the relevant parties but do not prohibit the practical delegation of UDI-related activities.
Therefore:
1. Manufacturers may delegate operational activities
A manufacturer may contractually delegate the practical operations involved in UDI application, labeling and EUDAMED data entry to a distributor or other third party.
2. Distributors may act on behalf of manufacturers
A distributor may communicate with an issuing entity on behalf of the manufacturer.
However, the legal responsibility for UDI compliance remains entirely with the manufacturer.
Delegating the operation does not mean transferring the legal responsibility or becoming the manufacturer.
3. When can a distributor apply for a UDI-DI as a manufacturer?
Only where the distributor meets the requirements of Article 16(1) and assumes all obligations of a manufacturer, such as in a scenario where the distributor places a device under its own name or trademark and assumes the corresponding manufacturer responsibilities.
In such a case, the distributor may obtain its own Manufacturer SRN, Basic UDI-DI and UDI-DI.
This is fundamentally different from simply selling a manufacturer’s device under a private label under the circumstances described in Article 16(1)(a).
5. Recommendations for Chinese Companies Expanding into the EU
Chinese Manufacturer + OEM / EU Authorized Representative + European Distributor Private Label
Companies should immediately review their EUDAMED records.
If a UDI-DI has been registered under the distributor’s name, the manufacturer should reassess the arrangement and, where necessary, obtain a new UDI-DI from GS1 or another issuing entity under the manufacturer’s own name, with the relevant UDI-DIs consolidated under the same Basic UDI-DI.
Update Distribution Agreements
Distribution agreements should clearly specify that UDI assignment is the responsibility of the manufacturer.
Where necessary, the agreement can authorize the distributor to carry out specific UDI-related operational activities on behalf of the manufacturer.
European Distributors
European distributors should stop independently applying for UDI-DIs where they are acting only as distributors.
Instead, they should perform UDI-related activities under authorization from the manufacturer.
Importantly, the ability to sell products under a private label in accordance with Article 16(1)(a) is not, by itself, affected.
Legacy Devices
For legacy devices, companies should complete the necessary EUDAMED data review and correction before November 28, 2026, in order to avoid being identified as non-compliant after the mandatory requirements take effect.
Conclusion
The key message from the MDCG position is straightforward:
The entity that appears as the legal manufacturer on the device label is the party responsible for assigning the UDI-DI and maintaining the corresponding UDI information in EUDAMED.
A distributor may perform UDI-related operations on behalf of the manufacturer, but this does not transfer the underlying legal responsibility.
For companies using OEM, private-label or multi-brand distribution models, it is therefore important to review UDI allocation, issuing-entity accounts, manufacturer SRNs and EUDAMED records as soon as possible to ensure that the UDI ownership, manufacturer identity and regulatory responsibilities remain consistent.