The Medical Device Coordination Group In Vitro Diagnostic Medical Devices Classification Guidance revises SARS-CoV-2

Posted on 03.04.2025

The European Medical Device Coordination Group (MDCG) has released the fourth revision of the MDCG 2020-16 Guidance on classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746. This March 2025 update introduces important changes regarding SARS-CoV-2 diagnostics.

Self-tests for SARS-CoV-2 are listed as an example under Class C, while all other SARS-CoV-2 tests are now regarded as Class B. Importantly, SARS-CoV and emerging strains will continue to be assessed based on Class D criteria. This regulatory amendment reflects the ongoing evolution of COVID-19 management.

In addition to these changes, the revision also includes editorial amendments aimed at improving the clarity and accuracy of the guidance.

This update is crucial for manufacturers, regulators, and healthcare providers to ensure current classification of SARS-CoV-2 diagnostic devices. For further details, the full document can be accessed here.

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