On 5 May 2017, the new EU MDR 2017/745 and IVDR 2017/746 regulations were published and formally introduced the UDI system in the EU. One of the components of a UDI system is the UDI itself, which allows for the unambiguous identification of a specific device on the market and is composed of the UDI-DI and UDI-PI.
This whitepaper provides an overview of the EU UDI system, its requirements and the status of EUDAMED, along with some practical recommendations for manufacturers to support their UDI system compliance efforts.
