MHRA Consultation on Future of Medical Device Regulation

Priscilla Lynch 

September 21, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week public consultation on the future of medical device regulation.

The consultation is seeking views from across the medical device and health care sectors, medical practitioners, patients and the wider public to inform the MHRA’s future approach. The MHRA would like to hear from those who research, manufacture, supply and use medical devices.

The consultation is comprehensive—covering a broad range of regulatory issues—from requirements for running clinical investigations to how devices are assessed before being placed on the market through to importer and distributor obligations and post-market surveillance to transparency and the role of patients.

“It provides a once in a generation opportunity to ensure the safety and quality of medical devices that many of us rely on, and from which we all benefit,” said the MHRA.

Dr June Raine, chief executive of the MHRA, said: “The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart."

"We know that a problem with a medical device can have a significant impact on people’s lives. This consultation offers a once in lifetime chance to help shape the regulations. In order to reach this goal, we want to hear from a wide range of people. Delivering for patients is central to our work and we fully recognise the importance of the public and patients’ perspectives and encourage them to share their views during this consultation."

Over the coming months, the MHRA will be running a number of webinars giving more information about the background and scope of this consultation and how to respond.

The consultation will close at 11.45 pm on 25 November 2021.

This article originally appeared on Univadis, part of the Medscape Professional Network.


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