UDI Helpdesk by the EU Commission!
17/5/2021
In the News,
On 17th May 2021, in a press update, the European Commission released some vital information with regards to UDI as a part of EU MDR.
As per the note, the European Commission has launched a new helpdesk to support economic operators in implementing the obligations and requirements introduced by the new UDI system.
The helpdesk provides support on UDI assignment, labelling and registration of devices. It also provides support on the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to manufacturers and other natural or legal persons required by the MDR and IVDR to use it.
You can access the UDI Support Desk here.
Experts at Med-Di-Dia welcome this initiative from the European Commission especially since many companies have been in the dark about the requirements for UDI. Also, with so much change happening in this booming sector, Medical Device manufacturers need plenty of guidance to help them through the maze of new regulatory requirements to ensure they can remain compliant and operational. It’s important to remember that not all devices need a UDI-carrier on their labelling as from 26 May 2021 because a defined transition period has been agreed. For example, under MDR Article 123(3)(f), Article 27(4), the placing of UDI-carriers on the labels of Class I medical devices is not mandatory until 26 May 2025 although, if they wish, manufacturers can choose to apply the UDI-carrier at any time ahead of this date.
Feel Free to contact us for a Free Consultation
Call: +353 (0)91-704804
Email: mdd@mddltd.com
