EU: UDI – Helpdesk and a new MDCG Guidance

The European Commission has launched a new helpdesk to support implementing the requirements introduced by the new Unique Device Identification (UDI) system within the context of the new Medical Device Regulation.

Acting as a resource centre, it provides support on UDI assignment, labelling and registration of devices. It also advises on the use of the European Medical Devices Nomenclature (EMDN).

You can find the Helpdesk here.

The European Commission has also published a new MDCG 2018-1 Rev.4. This guidance is intended to provide a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes. You can find the guidance here.


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