New Revision of MDCG 2020-16 Guidance on IVD Classification: Key Updates in Version 4

The Medical Device Coordination Group (MDCG) published Revision 4 of its guidance document MDCG 2020-16, titled "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746". This updated version provides further clarification on the application of the classification rules outlined in Annex VIII of the IVDR.

As the European Authorised Representative for many IVD manufacturers, MedNet EC-REP supports its clients in understanding and implementing these regulatory updates. Below, we highlight the main changes introduced in Revision 4 and what they mean for IVD manufacturers placing products on the EU market.

What’s New in Revision 4?

The main changes in this revision concern the SARS-CoV-2 tests. They are now no longer classified in class D, but in class C in the case of self-tests and in class B in the case of tests for professional use. This is reflected in the amended examples for Rule 1 (second indent), Rule 4 and Rule 6.

With this revision, the MDCG continues its effort to improve regulatory clarity and support consistent implementation across the EU. Manufacturers are encouraged to review the updated guidance in detail and assess whether any of their products may be affected by the revised interpretation of classification rules.

Download the full Document: MDCG 2020-16 rev.4