MDCG update: classification revision of SARS-CoV-2 tests

Today, 18 March 2025, MDCG just released a new version of MDCG 2020-16. This guidance addresses the classification of in vitro
diagnostic medical devices under IVD Regulation (IVDR). The main update concerns the classification revision of SARS-CoV-2 tests.

New IVDR classification of SARS-CoV-2 tests

The revised guidance provides examples of classification of SARS CoV-2 detection tests. Previously all classified as class D IVDs, the tests are not subject to different rules:

• Class A: standalone kits intended for the collection of saliva by the lay person for the purpose of detection of SARS-CoV-2 (by another device placed on the market separately).
• Class B: devices intended for the detection of SARS-CoV-2 and devices intended for the detection of antibodies against SARS-CoV-2.
• Class C: self-testing devices intended for the detection of SARS CoV-2 or antibodies against SARS CoV-2.
• Class D: devices intended for the detection of SARS CoV.

Expert panel advise

In January 2025, the European Commission published the advice on IVDs testing SARS-CoV-2 issued by the IVDR Expert Panel from the European Medicines Agency (EMA). The assessment suggests that high-risk groups remain vulnerable to the COVID-19 disease and SARS-CoV-2 remains a highly transmissible and persistent virus, while it no longer causes a life-threatening disease with significant mortality level among the general population.

Impact on legacy devices: May 2025 deadline

By 26 May 2025, manufacturers of legacy IVDs classified as Class D under the IVDR have to submit an application with a notified body and have a Quality Management System (QMS) compliant with the IVDR. This revision of classification of SARS-CoV-2 tests changes the timeline for many legacy SARS-CoV-2 tests. The deadlines for IVDR legacy devices are:

• Up-classified to Class D and devices covered by an IVDD CE Certificate: application submission by 26 May 2025 and QMS compliant with IVDR by 26 May 2025.
• Up-classified to Class C: application submission by 26 May 2026 and QMS compliant with IVDR by 26 May 2025.
• Up-classified to Class B and A sterile: application submission by 26 May 2027 and QMS compliant with IVDR by 26 May 2025.

For any questions of compliance of medical devices and IVDs, ask MDlaw. You can contact us here or at mdlaw@obelis.net.