A medical device manufacturer’s experience of UDI and its implementation
LINET spol. s r.o. is a major European manufacturer of hospital and nursing beds.
Although it may seem that Unique Device Identification (UDI) only means the addition of a barcode on a label and the entry of certain information into the UDI local database, LINET found the implementation of UDI to be a very complex task requiring money, equipment, people and time.
The main objective of UDI implementation must be a process that is sufficiently robust and ensures that each medical device is clearly identified, and that correct information will be entered at the correct time into a relevant UDI database. This process must be integrated into the manufacturer’s quality management system.