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New documents published by the Commission!

– The European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED! The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.     – The CND Nomenc...
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New Guidance published by the Commission!

The  two  new  Regulations  on  medical  devices  745/2017 (MDR) and  746/2017  (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which are to replace three EU Directives, apply progressively until May 2020 ...
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European Commission offers Guidance on UDIs!

Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs). GS1 Basic UDI-DI HIBCC Basic UDI-DI ICCBBA UDI HRI & AIDC Formats HIBCC UDI HRI & AIDC Formats ICCBBA Basic UDI-DI IFA Basi...
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New information on expert panels published

The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects. Now a decision of the European Commission (Implementing Decision (EU) 2019/1396) has...
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