Swift, Skilled, and Globally Influential - MHRA on the Verge of Becoming a Pioneer in Flexible Regulation of Medical Technology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a refreshed strategic direction, focusing on patient and public safety, accelerated access to innovations, and fostering innovation through regulatory reform.
According to James Pound, Interim Executive Director of Innovation and Compliance, the success of the MHRA in this next chapter is critical. The agency aims to build a world-class safety and surveillance system using comprehensive real-world data for patient and public protection.
At the heart of the MHRA's strategy is a commitment to reducing barriers to market entry for medical devices and innovations. This involves implementing a faster, risk-based, and predictable regulatory framework, creating an innovation-friendly domestic route for UK Conformity Assessment (UKCA) certification, and leveraging international reliance and recognition routes to streamline approvals for products already authorized elsewhere.
The MHRA also plans to strengthen its capacity to support more rapid approvals, particularly for AI and software-based medical technologies. A new AI regulatory framework is expected in 2026, aimed at helping clinicians access proven, safe innovations sooner.
To ensure patient safety and effective care, the MHRA will work closely with the National Institute for Health and Care Excellence (NICE) to make health technology assessments more timely, agile, and transparent. This dynamic regulatory environment aims to provide clinicians with clear guidance on clinically and cost-effective treatments.
The MHRA also aims to facilitate the adoption of innovations in the NHS via new pathways such as the ‘innovator passport’, which enables earlier and system-wide rollout of effective digital health tools, AI diagnostics, and medical devices.
The strategy is backed by significant investment, part of a £2 billion-plus government funding package, which will enhance MHRA’s regulatory capabilities, reduce bureaucracy, and support accelerated clinical trials, streamlined market access, and the embedding of research more effectively within the NHS.
Julian Beach, MHRA's Interim Director of Healthcare Quality and Access, stated that the MHRA's approval decisions are made on time, every time. The agency aims to maintain the UK as a research powerhouse, leveraging its world-class infrastructure, research base, and rapid approvals.
In summary, the MHRA's strategy places patient and public safety at the core while speeding access to innovations. It achieves this through regulatory modernization, international cooperation, investment in health data infrastructure, and fostering a dynamic environment for MedTech innovation and adoption within the NHS. The MHRA's CEO, Lawrence Tallon, has identified patient and public safety, accelerated access, and innovation as strategic priorities, and the agency intends to move upstream, positioning itself as an engine of innovation to expedite the delivery of cutting-edge new treatments and technologies to patients and the NHS.
[1] Life Sciences Sector Plan (July 2025) [2] MHRA Annual Report and Accounts 2024-2025 [3] UK Government's Life Sciences Vision (2020) [4] Industrial Strategy: Building a Britain fit for the future (2017) [5] Accelerating UK Life Sciences: A Modern Industrial Strategy for the sector (2021)
- The MHRA's strategic direction is geared towards fostering innovation through regulatory reform, particularly in clinical trials for new medical-conditions, by leveraging technology, finance, and education-and-self-development.
- In the realm of digital health, the MHRA aims to streamline approvals for AI and software-based medical technologies, setting up a new AI regulatory framework by 2026, with an emphasis on patient safety and effective care.
- The MHRA seeks to reduce barriers to market entry for medical devices, creating a business-friendly environment through a faster, risk-based, and predictable regulatory framework, such as the UKCA certification.
- To further promote the adoption of innovations, the MHRA is introducing pathways like the ‘innovator passport’, which facilitates the earlier and system-wide rollout of digital health tools, AI diagnostics, and medical devices.
- The strategy is backed by significant investment from the government, allocating funds for enhancing the MHRA’s regulatory capabilities, reducing bureaucracy, and supporting science and research in the health-and-wellness sector.
