MHRA sets out new plans to protect safety for UK patients

MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to medical technologies.

A clear path ahead has been set out for the development of new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, whilst enhancing the UK’s position as an environment for medical technology innovators.

This new ‘roadmap’ for new regulations, from the Medicines and Healthcare products Regulatory Agency (MHRA), will enhance the UK’s ability to benefit from rapidly advancing medical technology, offering new opportunities for patients and healthcare.

Transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, all demand a new regulatory framework.

The MHRA’s roadmap sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.

The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

Dr Laura Squire, the MHRA’s medtech regulatory reform lead and chief officer healthcare, quality and access, said: "Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery. 

We are therefore delighted to begin this new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years.

The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health."