News & Views

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Warning – For risk class I devices!

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...

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Standards free of charge!

CEN and CENELEC make European standards freely available relevant for the crisis.  Standards are created by standard organizations who carefully draf...

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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 t...

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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 ...

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