Complying with the Medical Device Regulation (MDR)
According to the MDR, manufacturers should put a UDI on (the packaging of) medical devices and in some cases on the medical device itself. Also, entering product data in Eudamed, the central European database is mandatory and the assignment of a Basic UDI-DI is required to identify a product family. To identify a product model or product family, GS1 has the standard Global Model Number (GMN).
- The deadline for registering EUDAMED and UDI assignment all classes of medical devices (III, IIb, IIa, I) is 26 May 2021. We recommend you put UDIs on medical devices a soon as possible so healthcare institutions can scan your products.
- From 26 May 2021 the Dutch hospitals and clinics are required to register all class III medical devices.