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UK to strengthen regulation of innovative medical devices

New plans have been unveiled to strengthen the regulation of medical devices, intending to improve patient safety and encourage innovation. Given the need for innovation to be placed at the heart of health and life sciences, we examine opinion of the new announcement.

New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published by the Department of Health and Social Care.

Following the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) is hoping to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the UK.

The package of reforms will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; new technologies such as smartphone apps and Artificial Intelligence (AI); as well as certain cosmetic products like dermal fillers.

The new measures which aim to improve outcomes include:

  • Strengthening the MHRA’s powers to act to keep patients safe – Giving the public and patients greater assurance on both the performance and safety of the highest-risk medical devices, such as those which need to be implanted.
  • Increasing the scope and extent of regulation to respond to public need – Enhancing systems that are already in place to better protect users of medical devices and certain cosmetic products, and providing greater assurance of their performance and safety.
  • Addressing health disparities and mitigating identified inequities throughout medical devices development and use – mitigating against inequities in medical devices, ensuring they function as intended for diverse populations. The government has launched a review into the potential equity issues in the design and use of medical devices to tackle health inequalities.
  • Making the UK a focus for innovation. Ensuring the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs.

Former Health and Social Care Secretary Sajid Javid commented on the potential benefits leaving the EU has granted the UK in this space. He said:

“Now we have left the EU, these new changes will allow innovation to thrive and ensure UK patients are among the first to benefit from technological breakthroughs.”

“We are now able to introduce some of the most robust safety measures in the world for medical devices to ensure patients are protected.”

Chief Executive of the MHRA, Dr June Raine commented:

“As a regulator, our priority is to protect patients and the public and make it easier and quicker for patients to access the medical devices and treatments they need.”

“We all know the importance of medical devices in our day to day lives and your input has been invaluable in helping us to shape the future regulations and ensuring continued patient safety and access.”

Environmental concerns

However, criticism has come from some figures in the life sciences sector that these reforms ignore environmental impacts. Given the substantial part healthcare and life sciences has to play in achieve net zero by 2050, sustainability of health is vital alongside innovation.

The concern largely stems from the fact that the Government shelved a proposed requirement for manufacturers to complete an environmental and public health impact assessment as part of the conformity assessment process for a medical device. They will also not proceed with new waste management responsibilities in the medical device supply chain to reduce environmental impacts and increase the use of less hazardous materials that are easier to dispose of safely.

The government said that it needed to consult further on both proposals to understand the “capacity and infrastructure concerns” that respondents raised. Many respondents also noted that their products and practices are already subject to various environmental regulations and highlighted the need to avoid setting duplicative requirements. 

Final thought

On the face of it, the steps taken by the Government should be applauded by the healthcare sector as an action to improve innovative practices for an extremely important component of treatment and care. The market for medical devices in the UK is huge, with approximately 600,000 devices available today. As millions of people depend on these devices, the improvements on health outcomes and inequalities should take place. Nevertheless, the Government are clearly prioritising outcomes over long-term environmental sustainability in healthcare. Given the substantial importance to achieve sustainable health treatment and care, the UK will need to incorporate this further into reforms.

Looking to the future – later this year the Government will publish new regulations and guidance using powers in the 2021 Medicines and Medical Devices Act. The proposed changes are scheduled to come into effect in 2023 alongside a number of transition arrangements to ensure the industry has time to adapt.

Curia’s NHS Innovation & Life Sciences Commission is seeking to find implementable solutions in achieving innovation across the NHS and life sciences industry. For further information on upcoming inquiry sessions, follow Curia for updates here.

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