Key update on SARS-CoV-2 IVD (EU) classification

Posted on 06.02.2025

The European Commission’s In Vitro Diagnostics expert panel has concluded that SARS-CoV-2 no longer presents a life-threatening risk with significant mortality for the general European population. This decision will impact the classification of SARS-CoV-2 tests under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR).

While an update to the MDCG 2020-16 classification guidance may yet take several months, this expert opinion and the European Commission’s communication of 29 January 2025 provide welcome clarity for the industry, helping manufacturers navigate regulatory requirements with greater certainty.

For more information, please contact Iana Slobodeaniuc, Manager In Vitro Diagnostics.