EUDAMED user guide – UDI Devices
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Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro
diagnosis medical devices introduce an EU identification system for medical devices
based on a Unique Device Identifier (UDI).
The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their
UDIs/Devices information and to make it available to everyone.1