Companion diagnostic

Under the IVDR, companion diagnostics are class C, and the notified body must consult a medicines authority on the suitability of the device for the medicinal product. The link to the drug means drug and diagnostic timelines have to be planned together.

‘companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal product to: (a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or (b) 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, Article 2(7)