MDCG 2026-5 Clarifies UDI Assignment for Manufacturers and Distributors

The Medical Device Coordination Group (MDCG) published MDCG 2026-5 on 22 July 2026, clarifying UDI assignment responsibilities under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The position paper addresses private-label and distributor-brand arrangements and confirms that UDI ownership, legal responsibility, and EUDAMED registration remain with the manufacturer.

What MDCG 2026-5 clarifies

MDCG 2026-5 confirms that only manufacturers may receive and assign Unique Device Identifiers (UDI-DIs) in their own name, even when a medical device is marketed under a distributor's trade name. The clarification is intended to support consistent UDI management and accurate registration in EUDAMED.

Why was MDCG 2026-5 published?

Some distributors have marketed medical devices under their own trade names while keeping the original manufacturer identified on the product label. Based on their interpretation of Article 16(1)(a) of the MDR and IVDR, certain distributors considered that they could request their own UDI-DIs directly from an EU-recognized UDI issuing entity when an agreement with the manufacturer was in place.

MDCG 2026-5 explains that this interpretation is not consistent with the UDI responsibilities established by the MDR and IVDR.

Key clarifications

• Only manufacturers may obtain UDI-DIs in their own name from EU-recognized UDI issuing entities.
• UDI-DIs must be linked to the manufacturer, not the distributor.
• Manufacturers remain legally responsible for assigning and maintaining UDI information.
• The same medical device may have two different UDI-DIs when it is marketed under different trade names.
• Both UDI-DIs must be linked to the manufacturer and registered under the same Basic UDI-DI in EUDAMED, where applicable.
• Distributors, importers, and authorized representatives may not independently assign or register UDI-DIs in their own name.
• A manufacturer may delegate practical activities to a third party acting on its behalf, but the manufacturer's ultimate legal responsibility cannot be transferred.

Regulatory basis

The position paper cites the following requirements:

• MDR Article 10(7), Article 27, and Annex VI, Part C establish manufacturer obligations for UDI assignment, maintenance, and registration.
• IVDR Article 10(6), Article 24, and Annex VI, Part C establish the corresponding obligations for IVD manufacturers.

MDCG 2026-5 is an MDCG position paper rather than a legally binding European Commission interpretation. It states that only the Court of Justice of the European Union can give binding interpretations of Union law.

What this means for manufacturers and distributors

Manufacturers supplying products through private-label or distributor-brand arrangements should review their UDI procedures and agreements to ensure that all UDI-DIs remain linked to the manufacturer. Manufacturers remain responsible for:

• Obtaining UDI-DIs.
• Maintaining UDI records.
• Registering UDI information in EUDAMED.
• Ensuring compliance with the MDR and IVDR.

Distributors should verify that they are not independently requesting UDI-DIs in their own name. Organizations with existing private-label arrangements should also review their documentation and internal processes against the position paper.

Key takeaways

• Only manufacturers may receive and assign UDI-DIs in their own name.
• UDI-DIs are linked to the manufacturer.
• Multiple UDI-DIs are permitted for the same device under different trade names.
• Manufacturers must register applicable UDI-DIs under the same Basic UDI-DI in EUDAMED.
• Third parties may perform practical activities on behalf of a manufacturer, but legal responsibility remains with the manufacturer.

Conclusion

MDCG 2026-5 clarifies UDI responsibilities under the EU MDR and IVDR for private-label and distributor-brand arrangements. Manufacturers and distributors should review their regulatory processes and agreements to ensure that UDI assignment, maintenance, and EUDAMED registration follow the clarified approach.

Read the official MDCG 2026-5 position paper and learn more about EU medical device and IVD regulation.