With the publication of revision 4 of the MDCG 2022-16 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746“ in March of this year, amongst other SARS-CoV-2 devices were re-classified.

• In summary, SARS-CoV-2 devices for professional use are classified as class B, whereas SARS-CoV-2 devices intended for lay use are classified as class C.
• The obligation remains to continue to classify SARS-CoV-2 devices in class D, if highly virulent strains or new strains are detected as well as if they are intended for particularly vulnerable patient groups.
• Furthermore, re-classification may be necessary in the future due to new mutations.

Manufacturers are required to provide appropriate rationale for their classification.