Forward-Thinking and Skilled - MHRA Gearing Up to take the Lead in Globally Comprehensive Regulation of Medical Technology Products
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has announced a refreshed strategic direction for MedTech regulation, aiming to ensure patient and public safety, accelerate access to new treatments and technologies, and drive innovation in the UK.
In an effort to cement the UK's position as a research powerhouse, James Pound, the Interim Executive Director of Innovation and Compliance at the MHRA, has identified three key pillars for success: cementing the UK as a research powerhouse, moving upstream to position the MHRA as an engine of innovation, and turbocharging the AI revolution in healthcare and efficiency.
To achieve these goals, the MHRA plans to reduce barriers to market entry for MedTech innovations by creating a reformed regulatory framework with an innovation-friendly domestic route to UK Conformity Assessment (UKCA) certification. This move is expected to streamline market access for products that have previously obtained comparable approvals elsewhere.
The MHRA also aims to implement fast and expert regulation for emerging technologies, particularly aiming to become the fastest regulator for AI and software by launching a new AI regulatory framework by 2026. Strengthening post-market surveillance is another key aspect of the strategy, with new legislation effective from June 2025 requiring manufacturers to proactively monitor safety and performance, enhancing patient safety through improved device traceability and incident management.
In addition, the MHRA is focusing on streamlining coordination between itself and the National Institute for Health and Care Excellence (NICE) to ensure that patients receive the most effective care rapidly through agile, transparent technology assessments that support timely adoption of innovations. Boosting clinical research and innovation is also a priority, with the MHRA supporting increased clinical trial activity, embedded research within the NHS, and investments in health data and genomics infrastructure to accelerate MedTech development and adoption.
The aim for accelerated access is to speed up decisions on clinical trials and core licensing for new medicines, medical products, and technologies. The MHRA's CEO, Lawrence Tallon, has identified three strategic aims: patient and public safety, accelerated access, and 10X innovation, which aims to increase the MHRA's contribution to UK life sciences for the benefit of the public, the NHS, and economic growth.
The MHRA is also enhancing its collaborative working with NICE to provide a new joined-up licensing and guidance pathway. Julian Beach, the Interim Director of Healthcare Quality and Access at the MHRA, stated that the agency's approval decisions are always made on time.
Overall, the MHRA’s strategy is designed to balance robust safety standards with accelerated pathways that foster innovation and faster patient access to medical devices and technologies within the UK market. The agency's focus is now on capitalizing on its national decision-making ability with new guidance that will enable innovation in new and existing areas, while working with international partners to establish the best outcomes for patients in the UK.
Science and health-and-wellness will benefit from the MHRA's focus on boosting clinical research and innovation, which involves supporting increased clinical trial activity, embedded research within the NHS, and investments in health data and genomics infrastructure to accelerate MedTech development and adoption. Clinical trials and the development of new medical devices will be expedited through the MHRA's strategic aim of accelerated access, designed to speed up decisions on these aspects.
