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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;
  • Rapid...

In publishing its Guidelines on COVID-19 in vitro diagnostic tests and their performance, the European Commission is trying to encourage EU member states to take a similar approach in...

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