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NEW YORK (360Dx) — The European Medicines Agency this week published its first guidance to help test makers bring their products into compliance with new regulations.

The guidance is the first of several that will cover the new medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), which are set to come into force by 2020 and 2022, respectively.

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Oct
09
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PerkinElmer

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.