This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified bodies on companion diagnostics, as per Article 48(3), (4), (7) and (8) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
A companion diagnostic is defined in Article 2(7) of Regulation (EU) 2017/746 as follows:
‘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;
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