According to Articles 87 and 89 of Regulation (EU) 2017/745 relating to medical devices and Articles 82 and 84 of Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices, in the event of safety corrective action taken . to the device, the manufacturer shall ensure that the information is immediately provided to users of the device via a security notice. This notification enables the correct identification of the device(s) concerned, especially by clearly stating, on the one hand, the relevant UDIs, and on the other hand, all the measures that users must take.
In addition, in accordance with Article 27 and Part C of Annex VI. the aforementioned Regulation (EU) 2017/745 and Article 24 and Part C of Annex VI. to the aforementioned Regulation (EU) 2017/746, the IUD, which allows identification and facilitates the traceability of the device, is located on the label of the specified device and on all higher levels of packaging.
In addition to the UDI, clearly printed on the label, there are one-dimensional or linear barcodes, two-dimensional barcodes and RFID identifiers. These technologies, which enable automatic data collection, are called “AIDC” (automatic identification and data collection) and are used specifically for computerized device inventory management.