This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural aspects of the consultation procedure to the EMA by a notified body on a companion diagnostic (CDx). As per the Regulation (EU) 2017/746, a CDx is essential for defining patients’ eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers (i.e., biomarkers1) identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective. Such biomarker(s) can be present in healthy subjects and/or in patients…
