More importantly, why we all need to be prepared
This Will Impact Everyone
The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746.
This element will be key for the traceability of devices in Europe.
To be specific, the concept of UDI did appear on the IMDRF guidance issued in 2013. This defined the basis of this new technology. Nowadays, it´s not something new for the Medical Device Industry as it´s also a requirement for products delivered to the US market. But for manufacturers that are not selling their products in the United States of America, there will be some work to do.
There is Even A Podcast
The folks at Easy Medical Device have put on a podcast to explain UDI to the uninitiated. You can listen here: