We would like to inform you that as of 26 May 2025, all medical device manufacturers, regardless of the risk class of the medical device, are required to place the UDI carrier on the medical device label and to all higher levels of packaging.

This requirement also applies to manufacturers of in vitro diagnostic medical devices classified in risk classes B, C, D, except for in vitro diagnostic medical devices classified in risk class A, for which the application of the UDI on the label is mandatory starting with 26 May 2027.

The UDI system, the unique device identification system of a medical device, is set out in Articles 27 of the MDR and 24 of the IVDR respectively. According to these Articles, the unique device identification system (the “UDI system”) described in Annex VI Part C allows for the identification and facilitates the traceability of devices, other than custom-made devices and devices under investigation, and consists of the following:

(a) the production of a UDI that comprises the following:
– A UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI.
– A UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI.

(b) the placing of the UDI carrier on the label of the device or on its packaging

(c) the storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9, respectively, of this Article;

(d) the establishment of an electronic database for Unique Device Identification (the ‘UDI database’), in accordance with Article 28 of IVDR.

In accordance with Article 29(1) of the MDR and Article 26(1) of the IVDR respectively, before placing a device, other than a custom-made one, on the market, the manufacturer, in accordance with the rules of the issuing entity referred to in Article 27(2) of the MDR and Article 24(2) of the IVDR respectively, shall assign a basic UDI-DI, as defined in Annex VI Part C, to the device and submit it to the UDI database together with the other essential data elements, as referred to in Annex VI Part B, related to that device.

According to Annex VI part C to the MDR, Basic UDI-DI is the access key for device-related information entered in the UDI database and is mentioned in relevant EU certificates and declarations of conformity.

Failure to comply with the provisions of Art. 27 and 29 of the MDR and Art. 24 and 26 of the IVDR are considered contraventions in accordance with Art. 28 of Emergency Government Ordinance 46/2022 and Art. 17 of Emergency Government Ordinance 137/2022.

According to 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 5-year period, from 27 June 2024 to 27 June 2029 by 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 organisations have been officially recognised by the European Commission as UDI issuing entities:
– GS1 AISBL,
– Health Industry Business Communications Council (HIBCC)
– ICCBBA
– Informationsstelle für Arzneispezialitäten — IFA GmbH

These Decisions were published in the Official Journal of the European Union. Thus, please note that only these 4 entities are designated by the Commission and can issue UDIs.

If you have contracted another organisation other than the 4 listed above for the issuance of a unique device identification system (“UDI system”) or if you are aware of such organisations claiming to be UDI issuing entities, please notify the National Agency for Medicines and Medical Devices of Romania – the Regulatory Directorate for Market Surveillance at the contact details available on the NAMMDR website (dgdm@anm.ro and drsp@anm.ro).