The European Commission made an announcement for manufacturers of SARS-CoV-2 tests, after scientific advice has been received from the IVD expert panel (see here). Previously, SARS-CoV-2 tests were classified as IVDR class D devices. The virus is no longer considered to pose a life-threatening risk leading to a lower risk class for most devices:
- Tests for lay persons are considered to fall under risk class C.
- Test for professional users are considered to fall under risk class B.
If applicable, it is recommended to consult with the IVDR Notified Body and discuss how to proceed with the conformity assessment.