Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Regulating companion diagnostics: is it time for a major change?

This article was originally published in SRA

Executive Summary

Should the EU wait for the introduction of the forthcoming EU IVD Regulation (IVDR) to regulate companion diagnostics or should it create an entirely new and separate regulation for this product group? And if it does this now, could a new regulatory vehicle help to fast-track the IVDR and the Medical Device Regulation (MDR) that is also wending its way through the EU legislative process?




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts