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NEW YORK – The European Commission's Medical Device Coordination Group this week published new guidelines concerning the implementation of the In Vitro Diagnostic Regulation (IVDR).

MDCG includes representatives from all EU member states and is chaired by a representative of the European Commission. The new guidance concerns the technical assessment of certain devices under the IVDR, which is slated to come into force in May 2022.

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Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.