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MHRA launches roadmap for medtech regulations

The roadmap covers plans for regulations on medical technologies, including implantable devices, artificial intelligence and healthcare software, with core elements of a new framework to be in place by 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a roadmap, setting out plans for a new framework covering medical technologies.

The framework will cover both existing technologies, as well as future ones, including new implantable devices, the use of artificial intelligence (AI), software, and any diagnostic technologies used for early detection and prevention of disease.

The MHRA, which sits under the Department for Health and Social Care (DHSC), aims for the core elements of the framework to be in place by 2025.

Commenting on the proposed regulations, MHRA’s med tech regulatory reform lead and chief officer for healthcare, quality and access, Laura Squire, said the advances in medical technology offers huge opportunities for patient care and improvements in the delivery of healthcare.

“We are therefore delighted to begin this new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years,” she said.

“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health,” said Squire.

“The roadmap sets out how we will work with stakeholders including patients as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging UK reforms.”

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The plans come following a public consultation in 2021, calling for reform of the regulatory approach to medical technologies as the landscape continues to change.

According to the roadmap, the MHRA will launch an AI Airlock regulatory sandbox in the first half of 2024.

Peter Ellingworth, CEO of the Association of British HealthTech Industries, said international recognition will “ensure that UK patients maintain access to safe and effective health tech, that is both life-enhancing, and life-saving”, adding that the roadmap is an “important step in this regard and can help to drive innovation and growth into the UK, while enabling home-grown businesses to expand their global presence”.

The government also launched its inaugural medical technology strategy in February 2023, setting out how the health and social care system can reliably access safe, effective and innovative medical technologies.

As part of its med tech innovation drive, the government opened a £10m fund in September 2023 to help suppliers create innovative technologies that can quickly be introduced to the NHS.

The funding for the Innovative Devices Access Pathway allows manufacturers and innovators to apply for targeted support and advice on how to create products that will be adopted by the NHS.

In October 2023, the government also launched a £30m fund for integrated care systems across England to bid for funding to invest in medical technologies. 

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