Public consultation on future of medical device regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week consultation to gain views on changes to how medical devices will be regulated across the UK.

The MHRA is seeking views from across the medical devices and healthcare sectors, medical practitioners, patients and the wider public, to inform its future approach. 

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA now has the opportunity to create a world-leading regime that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices.

This 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.

Dr June Raine, Chief Executive of the MHRA, says: "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.

"This is your chance to make a difference to people’s experiences with devices by helping shape the regulations around medical devices – from how much scrutiny they face before they reach the market, to how they are tracked and monitored, and what actions are taken if problems with a device arise. It is also an opportunity to impact what products the MHRA regulates – for example, should the MHRA have a role in the regulation of other products which are similar to medical devices such as cosmetic coloured lenses or dermal fillers?"