New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published.
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:
Health and Social Care Secretary Sajid Javid says:
“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.”
Dr June Raine, Chief Executive of the MHRA, says:
“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 regulations will keep pace with new and emerging technologies, for example software and artificial intelligence (AI) which are increasingly being used in areas such as screening and diagnosis, as well as the management of chronic conditions and developing new treatments. The new measures will ensure innovations such as these are subjected to the same robust standards as medical devices, protecting patient safety while encouraging innovation to ensure UK patients are among the first to access cutting-edge healthcare.
Today’s announcement 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.
To continue reading this article please go to MHRA .