The Transition Sub Group (TSG) of the CAMD today presented the outcome of their discussions regarding transition-related provisions regarding the MDR (i.e. articles 120-123) and the IVDR (i.e. articles 110-113):
MDR: https://lnkd.in/dE2JSat
IVDR: https://lnkd.in/dTtEDxu
The contents shall be updated continuously.
I personally believe it's a good start! The documents clarify many things (e.g. that a manufacturer may have valid MDD and MDR certificates for the same product in parallel, clarification regarding transition timelines for products where the classification changes, sell-off provision etc.) – definitely worth reading!
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Beat U. Steffen
Founder, CEO
confinis ag
Duedingen
Switzerland
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