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EU’s COVID-19 IVD Guidelines Reflect Need For Nuanced Approach To Testing For Member States

 
• By Amanda Maxwell

New European Commission guidelines on COVID-19 IVD tests and their performance not only explain the regulatory requirements, but also detail why different levels of precision may be acceptable in different contexts.

Covid19_Test_Vial

Successful diagnostic testing for COVID-19 is crucial to managing and exiting the coronavirus pandemic. Ensuring the availability of enough accurate tests is challenging every EU member state, with some, such as Germany, faring better than others. (Also see "Germany’s COVID-19 Testing Leaps Again But Antibody Tests Not Ready" - Medtech Insight, 16 April, 2020.)

As of early April 2020, the numbers of COVID-19 devices CE-marked under the IVDD was as follows, according to commission estimates:

  • RT-PCR tests, 78;

Availability varies widely between member states. This is because, the commission says, manufacturers may sell them to non-EU markets or there may not be distributors selling these devices in all member states. Availability also varies over time, depending on, for example, logistic factors in manufacturing and distribution.

In publishing its Guidelines on COVID-19 in vitro diagnostic tests and their performance, the European Commission is trying to...

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• By Francesca Bruce

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Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

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