If you already have a UDI system in place for another market (e.g., US FDA), then this is generally sufficient for Europe. The main differences are:
The EU Commission only recognizes the following UDI issuing agencies: GS1, HIBCC, ICCBBA and IFA GmbH.
The MDR/IVDR introduces a new concept: the Basic UDI-DI. This is unique to Europe, and must be established as part of the UDI system.
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