31.07.2025
To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties
In line with the 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, renewed for a five-year period, from 27 June 27 2024 to 27 June 2029 in line with the 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, the following organizations were officially recognized by the European Commission as UDI-issuing entities:
– GS1 AISBL,
– Health Industry Business Communications Council (HIBCC)
– ICCBBA
– Informationsstelle für Arzneispezialitäten — IFA GmbH
These decisions have been published in the Official Journal of the European Union.
Thus, we inform you that only these 4 entities are designated by the Commission and can issue the UDI.
If you have contracted another organization apart from the 4 listed above for issuing the unique device identifier of a device (“UDI system”) or if you are aware of such organizations which claim to be issuing UDI, you need to notify the National Agency for Medicines and Medical Devices of Romania – the Regulatory Directorate, Market Supervision (dgdm@anm.ro and drsp@anm.ro), using the contact data available on the NAMMDR website.