UK to strengthen regulation of medical devices to protect patients
New plans to strengthen medical device regulations to improve patient safety and encourage innovation have been issued.
After leaving Britain from the European Union (EU), the Drug Regulatory Agency and Health Products (MHRA) have a unique opportunity to improve how medical devices and diagnostic medical devices in Vitro (IVD) are regulated in the UK.
The reform package will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; New technology such as smartphone applications and artificial intelligence (AI); as well as certain cosmetic products such as skin fillers.
Rules will compensate for new technology and those that arise, for example software and artificial intelligence (AI) which are increasingly widely used in fields such as screening and diagnosis, as well as management of chronic conditions and developing new treatments.
New steps will ensure this innovation experiences the same strong standards as medical devices, protecting patient safety while encouraging innovation to ensure British patients are the first to access the latest health care.
Today’s announcement follows a consultation on future medical device regulations where MHRA asks for views on various regulatory problems – from the requirements for carrying out clinical investigations, to how the device is assessed before.
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This is an ambitious and transformational reform program and MHRA will ensure that legislative changes in the system meet industrial needs and the health sector.
There will be work and sustainable involvement with industry and stakeholders while improving laws and applying changes.
MHRA will gradually phase in new requirements with transitional arrangements, to provide an industry that is enough time to adapt to change.
