SARS-CoV-2 IVD tests and the IVDR

Back in August, we have issued an article about a new guidance document published by the Medical Device Coordination Group (MDCG), MDCG 2021-21. The guidance document lays out specific requirements for the performance evaluation of IVD tests related to SARS-CoV-2.

We would like to make affected manufacturers aware again of the importance of this guidance document. Under the current IVD Directive (IVDD), the included provisions are voluntary as long as a good justification is in place to not follow the guidance. 

However, the document also says that the Commission considers adopting the included provisions as common specifications under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Common specifications also have a voluntary character, but in practice it is expected it will be impossible to justify an alternative approach. 

As a consequence, manufacturers should ensure to comply with the guidance requirements also in preparation for the IVDR. SARS-CoV-2 tests will have to fully comply to the IVDR by May 26, 2022 and tend to fall into the highest risk class D with a much higher level of scrutiny including certification by a notified body. 

Source: European Commission

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