Europe – Clinical performance studies with companion diagnostic (CDx) devices

Companion diagnostics (CDx) are a specific type of IVD, unfortunately not defined under the current European In Vitro Diagnostic Medical Device Directive (IVDD). The In-vitro Diagnostic Medical Devices Directive (IVDR) as well as ISO 20916, however, close this gap by defining CDx, and identify requirements for clinical performance (CP) studies with CDx.

What are companion diagnostics?

The new EU IVDR, whose date of application is May 26, 2022, defines in Article 2 (f) a ‘companion diagnostic’ as a device which is essential for the safe and effective use of a corresponding medicinal product to:

  1. identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
  2. identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.  

IVDR recitals 10 to 12 provide further information on the CDx concept…