EU Renews UDI Issuing Entities for Medical Devices (2024-2029)

On July 30th, 2024, the European Commission implemented Decision (EU) 2024/2120 regarding the renewal of issuing entities designated for the assignment of the Unique Device Identifiers (UDIs) for Medical Devices.

The European Commission has announced that the issuing entities listed in the Annex of the Implementing Decision (EU) 2019/939 are renewed for a period of five (5) years from June 27, 2024, until June 27, 2029.

The Annex mentions the following UDI issuing entities:

• • GS1 AISBL
  • Health Industry Business Communications Council (HIBCC)
  • ICCBBA
  • Informationsstelle für Arzneispezialitäten — IFA GmbH

For more information, you may find here the aforementioned Implementing Decisions:

• • DECISION (EU) 2019/939 – COMMISSION IMPLEMENTING DECISION (EU) 2019/ 939 – of 6 June 2019 – designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (europa.eu)
  • DECISION (EU) 2024/2120 – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices (europa.eu)

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If you have any questions or need help understanding the European Commision’s latest renewal of UDI issuing entities for medical devices, contact us so we can help you.

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