Hearing aid image

People are being encouraged to contribute their views to a public Medicines and Healthcare products Regulatory Agency (MHRA) consultation on changes to how medical devices will be regulated across the UK.

Launched by the MHRA – the regulator for medical devices used in the UK – the consultation gives the public the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future.

MHRA underlines that medical device regulation is very important, as users need to know that their devices are safe and effective. It says that regulation is particularly significant where fast-developing technology has changed, and continues to influence, the landscape for medical devices, bringing new, innovative devices to the UK market, including some health apps.

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The UK Government says the following about what medical devices are:

“According to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

    • diagnosis, prevention, monitoring, treatment or alleviation of disease
    • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
    • investigation, replacement or modification of the anatomy or of a physiological process, or
    • control of conception”

Medical devices encompass a wide range of assistive technologies, such as hearing aids, walking sticks, wheelchairs, prosthetics and so on.

Now, the MHRA is seeking views from across the medical devices and healthcare sectors, medical practitioners, patients and the wider public, to inform future approach. It particularly wants to hear from those who research, manufacture, supply and use medical devices.

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.

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.”

This consultation is comprehensive, covering a broad range of regulatory issues from requirements for running clinical investigations, and 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.

“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,” Dr June Raine continued. “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?”

People are encouraged to share their views to the public consultation, which can be accessed here

The consultation closes at 11.45pm on 25 November 2021.

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