EU buidings

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...
Swiss Authorized Representative

IvDO adopted!

It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in German language is available here. Now we need to wait for the final version to be published in the Swiss Federal Council website. Once it is published, c...
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