When Is An IVD A CDx? EU IVDR Guidance Updated To Include Flowchart

The EU Medical Device Coordination Group has issued a second revision to its guidance document on classification rules for in vitro diagnostics under the new regulation. The addition of a flowchart to determine when an IVD is a companion diagnostic is one key change.

The second revision of guidance endorsed by the Medical Device Coordination Group (MDCG) on classification rules for in vitro diagnostics, MDCG 2020-16, was published 10 February, almost exactly a year after the first revision of the original document was made, in January 2022.

In this latest version of the document, which is 46 pages long, several sections have been edited or revised,...