|Target Audience||Manufacturers, systems and procedure packs producers, kit producers|
|Products concerned||MD, IVD|
This document is in the form of questions and answers relating to the unique identification system on medical devices (UDI). It provides further details for operators on the application and practical implementation of the UDI requirements.
The questions and answers are structured around the following topics: UDI-DI, basic UDI-DI, UDI support on labelling, UDI rules for systems and procedure packs and configurable devices, retailing and sampling of devices for marketing purposes, rules for kits and UDI and the link between UDI and Eudamed