EU: EUDAMED – new documents from the European Commission and MDCG

On 15 February 2021, the European Commission published guidance on the management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED. MDR and the IVDR introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).The European Commission recalls in its guidance that it is unnecessary to assign a Basic UDI-DI and a UDI-DI to legacy devices.

You find this document here: Management of Legacy Devices – MDR EUDAMED

In May 2021, MDCG published a new „Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional“.

You can find the guidance here: MDCG 2021-1Rev.1Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

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