The MHRA has published its Regulatory Roadmap, intended to “protect patient safety and enable access without delay for UK patients to innovative medical technologies” including implantable devices, healthcare AI and software, and diagnostics for the early detection and prevention of disease.
These technologies, according to the MHRA, “all demand a new regulatory framework”, which sees the agency introduce a series of new Statutory Instruments, along with plans to put in place priority measures for patient safety and to have the “core elements” of the new framework in place by 2025.
The planned regulations are also designed to deliver “greater international harmonisation”, focusing on maintaining a more patient-centred and proportionate set of requirements for medical devices, which are responsive to technological advances.
Dr Laura Squire, MHRA med tech regulatory reform lead and chief officer for 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.”
She added that 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. The roadmap sets out how we will work with stakeholders including patients as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging UK reforms.”
For a visual timeline of the roadmap, please click here. It covers activities delivered between 2021 and 2023 and activities planned over 2024 and 2025, including stakeholder discussions around scope, classification and requirements and the launch of the new “regulatory sandbox” AI-Airlock: a partnership between government, regulators and industry “which will see advanced AI technology used in NHS settings safely ahead of regulatory approval”, in order to allow NHS patients to benefit early from emerging technologies. HTN covered an update on AI-Airlock here.
In other news from the MHRA, the agency, along with international partners the FDA and Health Canada, recently published five guiding principles for the development of predetermined change control plans (PCCPs), with the aim of removing “the regulatory burden for developers of machine-learning-enabled medical devices”.