Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

July 7, 2022

People talking around a laptop in a professional business location.

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;

Download EMA Guidance Document

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.


Wayfinding signs with arrows showing 'right' and 'wrong.'

July 13, 2022

EMA Good clinical practice (GCP) inspection procedures

The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...

Several COVID-19 vaccine vials lined up on a table.

June 24, 2022

EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus

8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...

Several vials of COVID-19 vaccines lined up on a table.

June 2, 2022

EMA: Procedural advice for vaccine platform technology master 5 file (vPTMF) certification (DRAFT)

This document is intended to provide advice to marketing authorisation (MA) applicants and marketing authorisation holders (MAHs) on issues associated with the submission, evaluation, certification...