MHRA Unveils Regulatory Roadmap for Medical Device Development in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has revealed its strategic plan for implementing new and robust regulations for medical devices in the UK. This roadmap aims to prioritize patient safety while facilitating access to innovative medical technologies for all UK patients. Additionally, it seeks to strengthen the UK’s position as a global leader in medical technology innovation.
The regulatory framework will address transformative technologies, such as new implantable devices, healthcare AI and software, and diagnostics for early disease detection and prevention, to ensure patient protection. Through a series of new Statutory Instruments, the MHRA intends to introduce enabling regulations.
The MHRA plans to implement priority measures to safeguard patient safety this year, with core components of the new framework anticipated to be rolled out by 2025.
Dr. Laura Squire, med tech regulatory reform lead and chief officer healthcare, quality, and access at MHRA, expressed enthusiasm for the plan, stating, “Today’s medical technology advancements present valuable opportunities for patient care and healthcare improvement. We are pleased to begin the new year by outlining a comprehensive plan for significant enhancements to the regulatory framework for medical devices over the next two years.”
The roadmap also outlines the MHRA’s collaboration with stakeholders, including patients, to gather feedback and provide guidance for successful reform implementation. Additionally, it includes the AI Airlock regulatory sandbox, set to launch in April 2024, which will serve as a collaborative space for the development of advanced AI medical devices.
Overall, the MHRA’s regulatory roadmap aims to create a supportive environment for innovative healthcare products while prioritizing patient safety and strengthening regulatory measures for medical devices in the UK.
