A new roadmap has been created to develop comprehensive regulations for medical devices in the UK, encompassing assistive technologies such as mobility scooters, hearing aids, and prosthetics.
These regulations aim to prioritize patient safety while ensuring that patients have timely access to the devices they need. Additionally, the initiative seeks to reinforce the UK’s status as a “world-leading” environment for medical technology innovation.
Released by the Medicines and Healthcare products Regulatory Agency (MHRA), this roadmap is intended to help the UK leverage rapidly evolving medical technologies, providing significant new opportunities for both patients and healthcare providers.
Emerging technologies, including implantable devices, healthcare AI, software applications, and diagnostics for early disease detection and prevention, require a new regulatory framework.
The MHRA’s roadmap outlines a strategy to implement enabling regulations through a series of new Statutory Instruments (SIs). Key measures for patient safety will be introduced this year, with essential elements of the new framework expected to be established by 2025.
Dr. Laura Squire, MHRA Med Tech Regulatory Reform Lead and Chief Officer of Healthcare, Quality and Access, commented:“The remarkable progress in medical technology offers significant chances to enhance patient care and improve healthcare services.”
“We are excited to begin this year by introducing an extensive plan for significant enhancements to the regulatory framework for medical devices over the next two years.”
For effectively implementing these comprehensive reforms in the UK, the roadmap details our approach to working with stakeholders, including patients, as we move forward, providing initial insights into what lies ahead and collecting feedback on the necessary guidance.
The planned regulations are also designed to promote greater international harmonization, establishing more patient-centered and proportionate requirements for medical devices that respond to technological advancements.
Peter Ellingworth, Chief Executive of the Association of British HealthTech Industries (ABHI), stated: “Global acknowledgment will guarantee that UK patients continue to have access to safe and effective HealthTech that improves and saves lives.”
With the potential to stimulate innovation and growth in the UK and enable domestic companies to expand their presence on the global stage, the launch of this roadmap marks an important turning point in this initiative.
“We look forward to partnering with the MHRA and continuing our engagement through international platforms, such as the International Medical Device Regulators Forum and the Global Medical Technology Alliance, to ensure effective implementation.”
