[Withdrawn] Factsheet: Devices Advisory Expert Committee
Updated 18 July 2024
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Top lines
Medical devices are an area of fast-moving innovation, offering opportunities to enhance patient outcomes. However, the way in which they are regulated is not as transparent as it could be.
The bill introduces a power to allow the government to establish a statutory expert advisory committee on medical devices. This replaces an existing, non-statutory committee on devices.
An independent statutory advisory committee will help strengthen the vigilance system for devices.
What the bill changes
The bill will allow for the existing devices committee to be placed on a statutory footing.
The statutory committee will be to provide independent expert advice to the Medicines and Healthcare products Regulatory Agency (MHRA) on matters relating to medical devices. This includes expert clinical and scientific input and advice on a wide range of aspects relating to the safe use of medical devices.
This will strengthen the MHRA’s ability to manage safety issues, providing greater assurance of surveillance and ensuring timely decisions are made and appropriate action is taken to help better protect patients.
Current system
The MHRA currently has a non-statutory Devices Expert Advisory Committee (DEAC). This means that there are no obligations for DEAC to provide advice within set timeframes or to include patients in the decision making.
There is already an established statutory committee (the Commission on Human Medicines) to provide advice on the safety, quality and efficacy of medicines.
The DEAC currently includes representatives from the devolved administrations and it is our intention for this to continue when established on a statutory basis.
How a statutory committee will differ from the current DEAC
DEAC provides MHRA with independent, external, expert clinical and scientific input and advice on a wide range of aspects relating to the safe use of medical devices, however there is no statutory basis or obligation for DEAC to provide advice within set timeframes or to include patients in the decision making.
Having a statutory basis for a medical devices advisory committee will support structured decision making and formal accountability with clear roles and responsibilities for independent expert advice.
Under powers provided for in this amendment to the bill, we would be able to set out in the regulation provisions around matters such as patient engagement, commissioning of research, independence from the Secretary of State, transparency and timelines for provision of advice.
Further background
Advice will be sought from the committee on matters relating to devices where the MHRA, or ministers, identify a need for the provision of scientific, technical and/or clinical advice. We would, for example, want to seek advice on emerging safety risks that are critical, complex or high risk to patients.
The advice of the committee would be used to inform MHRA regulatory decisions and recommendations.
The power in the bill also enables regulations to be made that would allow for the statutory committee to cooperatively work alongside other bodies with medical device expertise and the Commission on Human Medicines. This will help improve the government’s oversight of medical device issues.