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Medical Devices, Diagnostics and Digital Health

Chair: Dr Bruno Rosen

The Medical Devices, Diagnostics and Digital Health Expert Group consider discovery, development, regulatory processes and vigilance processes across these areas. External therapeutic devices (eg mechanical ventilators), implantable devices, in vitro diagnostics (in particular we are interested in novel molecular diagnostics and companion diagnostics), wearable technologies and digital therapeutics (eg Apps to support behavioural interventions).

There is some overlap with eHealth, but we do not regard this as within our remit per se.

The group also considers the impact that innovation in these areas has on ‘traditional medicines’.

Meet some of our members

Some of the Group's Outputs

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

Date: submitted November 2021

The Medical Devices 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.

How to get involved

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Email fpm@fpm.org.uk