Consultation on the future regulation of medical devices in the United Kingdom: MHRA

Date: submitted November 2021

The New Technology expert group led the drafting of the response to the MHRA’s consultation on the future regulation of medical devices in the United Kingdom. This proposed possible changes to the regulatory framework for medical devices in the UK and was very large in scale with over 70 questions. The MHRA received over 891 responses by the time the consultation exercise concluded including from 263 healthcare professionals and 56 healthcare institutions.

Call for evidence – Equity in medical devices: independent review

FPM Conversation: In Vitro Diagnostics – Companions or Not?

Date: July 2021

This meeting discussed and debated the rapidly evolving IVDs landscape. The session included pre-session special guests from FPM’s New Technology expert group Bob Holland, Rob Hastings, Bruno Rosen and Tim Higenbottam who participated.

There is increasing adoption of biomarkers and diagnostics/companion-diagnostics in clinical trials and clinical practice, leading to an ever-rising collaboration within and between pharmaceutical companies and in vitro diagnostic medical device manufacturers.

It is important that pharmaceutical physicians and scientists, across a variety of different roles, have an understanding of how the IVD regulatory landscape is continuing to rapidly change and, critically, how Pharmaceutical Companies are adapting by developing new strategies to ensure effective collaborations in the IVDs arena.

This FPM Conversation aimed to enhance attendees’ awareness of the major elements of relevant IVD regulation(s) and provide expert perspective on important strategic and practical aspects of developing and implementing IVDs in support of patients.

Find out more about the conversation in this blog.