For risk class I manufacturer!

  Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020. Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf – December 2019. I...
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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...