UK to strengthen regulation of medical devices to protect patients

New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published.

Following the UK’s exit from the European Union (EU), the Medicines and Healthcare products Regulatory Agency (MHRA) has a unique opportunity 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 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 and will update in due course.
• Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices. 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.
• Setting world-leading standards and building the new UKCA mark. Transforming a new stamp of certification, replacing the CE mark, into a trusted brand that signifies global safety, health and environment protection standards have been met for medical device products. This will in turn boost the MHRA’s global reputation and growing partnerships with other regulators.

Health and Social Care Secretary Sajid Javid 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."

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Source: Gov.UK, 26 June 2022