The MHRA has called for input into a consultation on how it can improve medical device regulation


The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week consultation on the future of medical device regulation. It is seeking opinions on improvements to the regulatory framework from those who research, manufacture, supply, and use medical devices.

The MHRA currently regulates medical devices used in the UK under the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA said it is now looking to create a world-leading regimen that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices.

The MHRA described the consultation as a ‘once in a generation opportunity to ensure the safety and quality of medical devices’, and said it ‘covers 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’.

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.

‘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.

‘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?’

Health and Social Care Secretary Sajid Javid said: ‘The UK is home to one of the world’s most renowned regulators, ensuring the safety and effectiveness of the medicines and medical devices that we all rely on. This consultation will allow us to revolutionise the regulation of medical devices, making sure our pioneering life sciences sector can continue to lead the world and safeguard the health of our nation.

’From pacemakers to contact lenses, wheelchairs to pregnancy tests, medical devices play a vital role for the vast majority of us, and I encourage everyone who wants to be a part of this mission to put forward their views.’

The consultation will close at 23.45 on 25 November 2021.

The MHRA said it plans to run a number of webinars over the coming months to provide more information about the consultation and how to respond.


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