According to Articles 87 and 89 of Regulation (EU) 2017/745 on medical devices and Articles 82 and 84 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, in the case of a safety corrective action in the field in relation to the device, the manufacturer ensures that the information is made known to the users of the device without delay through a safety notice in the field. This notification enables the correct identification of the device(s) involved, in particular including, on the one hand, the relevant UDIs and, on the other hand, any actions that users must take.
Moreover, in accordance with Article 27 and Part C of Annex VI. Regulation (EU) 2017/745 and Article 24 and Part C of Annex VI. Regulation (EU) 2017/746, cited above, the UDI, which authorizes identification and facilitates product traceability, is placed on the product label and on increasingly higher levels of packaging.
In addition to the UDI, clearly placed on the label, there are, for example, one-dimensional or linear barcodes, two-dimensional or matrix barcodes, RFID identifiers. These technologies, which enable automatic data capture, are called “AIDC” (automatic identification and data capture), and are used primarily for computerized device inventory management.