Implement Unique Device Identifier (UDI) system.

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:

1. The EU Commission only recognizes the following UDI issuing agencies: GS1, HIBCC, ICCBBA and IFA GmbH.
2. 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.