According to MDR (EU) 2017/745 and IVDR (EU) 2017/746, the manufacturer is the entity responsible for the entire UDI management process for each medical device placed on the European market.
The manufacturer has the following responsibilities:
- Assignment of the UDI and Basic UDI-DI;
- Registration of the UDI and the Basic UDI-DI in the European database EUDAMED,
- Applying the UDI carrier on all packaging levels and, in the case of reusable devices, directly on the device by direct marking.
Any distributor, importer or other natural or legal person who assumes the obligations incumbent on manufacturers, under Article 16(1), will also assume all obligations relating to UDI, including proper labelling.
Furthermore, should a distributor or importer perform operations such as the translation or repackaging of devices, activities described in Article 16(3), it must ensure that these procedures are carried out in such a way that the readability of the UDI medium and the information identifying the device are never compromised. All these specific activities will also have to be fully integrated into their quality management system.
