Michael Barbella, Managing Editor08.08.22
With its break from Europe now well in the past, the United Kingdom is taking steps to improve patient safety and boost medtech innovation.
The country's Medicines and Healthcare products Regulatory Agency (MHRA) has published new plans to strengthen medical device regulation. The package of reforms applies to medical devices such as hearing aids, X-ray machines, insulin pumps, new technologies such as smartphone apps and artificial intelligence (AI); and certain cosmetic products like dermal fillers.
"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," Health and Social Care Secretary Sajid Javid said.
The new measures include:
"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 would like to thank everyone who has shared their views as part of this consultation, including patients, industry and the healthcare sector," said Dr. June Raine, chief executive of the MHRA. "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.
The publication of new regulations follows a consultation on the future regulation of medical devices in which the MHRA asked for views on a broad range of regulatory issues—from requirements for running clinical investigations, to how devices are assessed before being placed on the market, through to importer and distributor obligations, and post-market safety monitoring to increase transparency and the role of patients. This is an ambitious, transformational programme of reform and the MHRA will ensure that legislative changes to the system meet the needs of industry and the healthcare sector.
There will be continued work and engagement with industry and stakeholders whilst refining legislation and implementing changes.
The MHRA will gradually phase in the new requirements with transitional arrangements, to give industry enough time to adapt to the change.
The country's Medicines and Healthcare products Regulatory Agency (MHRA) has published new plans to strengthen medical device regulation. The package of reforms applies to medical devices such as hearing aids, X-ray machines, insulin pumps, new technologies such as smartphone apps and artificial intelligence (AI); and certain cosmetic products like dermal fillers.
"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," Health and Social Care Secretary Sajid Javid said.
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 U.K. 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 U.K. patients 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
"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 would like to thank everyone who has shared their views as part of this consultation, including patients, industry and the healthcare sector," said Dr. June Raine, chief executive of the MHRA. "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.
The publication of new regulations follows a consultation on the future regulation of medical devices in which the MHRA asked for views on a broad range of regulatory issues—from requirements for running clinical investigations, to how devices are assessed before being placed on the market, through to importer and distributor obligations, and post-market safety monitoring to increase transparency and the role of patients. This is an ambitious, transformational programme of reform and the MHRA will ensure that legislative changes to the system meet the needs of industry and the healthcare sector.
There will be continued work and engagement with industry and stakeholders whilst refining legislation and implementing changes.
The MHRA will gradually phase in the new requirements with transitional arrangements, to give industry enough time to adapt to the change.