European Commission Renews UDI Issuing Entity Designations Until 2029

The European Commission has adopted Commission Implementing Decision (EU) 2024/2120, renewing the designation of issuing entities authorised to operate systems for the assignment of Unique Device Identifiers in the field of medical devices.

The Decision was adopted on 30 July 2024 and published in the Official Journal of the European Union on 1 August 2024.

Renewal of UDI Issuing Entities

The Decision renews the designation of the issuing entities listed in the Annex to Commission Implementing Decision (EU) 2019/939.

These issuing entities had originally been designated to operate UDI assignment systems under both Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

Five-Year Extension

According to the Decision, the designation of the issuing entities is renewed for a further period of five years.

The renewed designation applies from 27 June 2024 until 27 June 2029.

The Commission states that it assessed the four designated entities and established that each remained compliant with the relevant criteria and terms of designation.

Continuity of the UDI System

The renewal aims to ensure continuity in the operation of the UDI system across the European Union.

UDI plays an important role in device identification and traceability under the MDR and IVDR, supporting regulatory oversight, registration and post-market activities.

Impact on Medical Device and IVD Manufacturers

For medical device and IVD manufacturers, the renewal provides continuity regarding the entities authorised to issue UDI identifiers under the EU regulatory framework.

Manufacturers should continue to ensure that:

• UDI assignment is carried out through designated issuing entities;

• UDI obligations are fulfilled under the MDR and IVDR;

• UDI-DI and Basic UDI-DI information is managed correctly;

• device registration information remains aligned with UDI requirements;

• internal procedures reflect applicable UDI traceability obligations.

For manufacturers placing devices on the EU market, this Decision supports regulatory stability by confirming the continued availability of designated UDI issuing entities until 2029.