The Medical Device Regulation MDR 2017/745 has been fully applicable since May 26th, 2021. One of the new requirements is that Medical Devices (MDs) should be traceable through the entire supply chain, thus, from the manufacturer to the end user. To facilitate this requirement the European Commission (EC) is implementing a state-of-the-art database widely known as the European Database on Medical Devices (EUDAMED).
To be able to trace Medical Devices, each one should have a Unique Device Identifier, abbreviated as UDI. The UDI must be issued by an approved issuing entity such as GS1, the Health Industry Business Communications Council (HIBCC), etc. The UDI is composed of two elements, the Unique Device Identifier – Device Identifier (UDI-DI), and the Unique Device Identifier – Production Identifier (UDI-PI).