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Warning – For risk class I devices!

Posted on March 13, 2020 By mdss
Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true. MDSS concern: Clients who have class I devices and ...
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Standards free of charge!

Posted on March 3, 2020 By mdss
CEN and CENELEC make European standards freely available relevant for the crisis.  Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees the light and can be used. The European Union (EU) in general calls ou...
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For risk class I manufacturer!

Posted on January 23, 2020 By mdss
  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!

Posted on January 15, 2020 By mdss
– 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!

Posted on January 8, 2020 By mdss
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!

Posted on December 15, 2019 By mdss
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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