MHRA publishes regulatory roadmap for development of medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust regulations for medical devices in the UK.

The plans have been laid out to protect patient safety while at the same time enabling access to innovative medical technologies for all UK patients. In addition, the UK’s position as a world-leading environment for med tech innovators will be enhanced.

It is vital that transformative technology – such as new implantable devices, healthcare AI and software and diagnostics for the early detection and prevention of disease – has a regulatory framework to protect patients. Through a series of new Statutory Instruments, the roadmap sets out its plans to deliver enabling regulation.

This year, the MHRA will put in place priority measures to protect patient safety, while core elements of the new framework are planned to be rolled out by 2025.

Dr Laura Squire, med tech regulatory reform lead and chief officer healthcare, quality and access, MHRA, 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.”

Contained within the plans is also information on how the MHRA will work with stakeholders – including patients – as they move forward with the roadmap. Stakeholders will gain early sight of what is to come and be able to provide feedback about the guidance they will need to ensure the successful implementation of the reforms.

The roadmap includes the AI Airlock regulatory sandbox, which is due to launch in April 2024. The Airlock may well be of use for the full scope of AI as a medical device products anywhere that they may have the potential to benefit patient care. It is designed to be a collaborative space that will bring together expertise from regulatory organisations, government, innovators, academia and the NHS. The virtual area will enable developers to generate robust evidence for their advanced technologies.