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Regulator launches consultation on future of medical device regulation

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week consultation process on future of medical device regulation, asking the general public to share their experience and contribute to regulatory framework.

It has also asked people across the medical devices and healthcare sectors, medical practitioners and patients to share their views.


Currently, medical devices in the UK are regulated under the Medical Devices Regulations Act 2002. After the country’s departure from the European Union, the regulator is working to create a new regime priortising patient safety and streamlining the approval of medical devices.

Dr June Raine, chief executive of the MHRA, said: “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.

Health secretary Sajid Javid said: “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 on November 25.

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