04.07.2025
To the attention of Romanian manufacturers of medical devices and in vitro diagnostic medical devices and all interested parties
We inform you that starting with 26 May 2025, all the manufacturers of medical devices, regardless of the risk class of the medical device, have the obligation to apply the UDI support on the label of medical devices and on all outer layers of the packaging, in line with Article 123 (3) (f) and Article 27 (4) of the MDR.
Moreover, this obligation also applies to all manufacturers of in vitro diagnostic medical devices in the risk classes B, C, D according to Article 113 (3) (e) and Article 24 (4) of the IVDR.
For in vitro diagnostic medical devices in the risk class A, the imprinting of the UDI support on the label is mandatory starting with 26 May 2027.