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Important News for IVD and MD Manufacturers!

  Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices was published in ...
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EU MDR Bridge

EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)? The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to h...
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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 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 ...