The Medicines and Healthcare Products Regulatory Agency (MRHA) has published its official response to its consultation on the future of medical devices regulation in the United Kingdom.
The MRHA’s consultation, which was released on 26th June 2022 stated that, following the UK’s exit from the European Union, “we have a unique opportunity to improve how medical devices and in vitro diagnostic medical devices (IVDs) are regulated in the United Kingdom.”
Sajid Javid, Health and social care secretary 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.”
The consultation stated that the MHRA’s purpose is clear: to protect patients and the public and facilitate access for UK patients to the latest advances the MedTech sector can offer.
According to the government, the 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 will involve: strengthening the MHRA’s powers to act to keep patients safe; increasing the scope and extent of regulation to respond to public need; addressing health disparities and mitigating identified inequities throughout medical devices development and use; making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices; setting world-leading standards and building the new UKCA mark.
Dr June Raine, chief executive of the MHRA, added: “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."
“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 MHRA will gradually phase in the new requirements and the new regulatory changes are planned to come into force in July 2023.