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The Medicines and Healthcare products Regulatory Agency has published its Strategy to 2030 alongside a dedicated HealthTech explainer. The documents bring regulatory reform, international cooperation, safety, data and support for innovation into a single agency-wide plan. Much of the strategy applies across medicines and HealthTech, while the explainer identifies the elements most relevant to medical devices, IVDs and digital health. 

MHRA presents regulation as supporting patient access, public confidence and economic growth. It links speed, predictability and scientific capability with decisions about where companies develop and launch products. For our sector, the published programme includes pre-market reform, support for advanced diagnostics and innovative technologies, stronger post-market surveillance and closer international cooperation. If implemented effectively, these measures have the potential to make the UK a more attractive place to develop, introduce and scale HealthTech in the UK and globally. 

Recognition and Reliance: Turning Ambition into Practice

The Agency's update confirms its intention to expand recognition and reliance with trusted regulators. It refers to work with the US Food and Drug Administration to explore mutual recognition for medical devices and long-term recognition in Great Britain for devices compliant with the EU Medical Device Regulation and In Vitro Diagnostic Medical Devices Regulation. 

Recognition and reliance could help reduce duplication, strengthen supply resilience and give patients earlier access to new technologies. The key will be how this works in practice, with industry needing clear guidance on eligibility, evidence requirements and how CE recognition and wider international reliance will work alongside domestic assessments and Approved Bodies.

Modernising Regulatory Infrastructure and Services

Effective registration, reporting and surveillance systems are essential to modern HealthTech regulation. The MHRA plans to upgrade or replace key systems, improve transparency and traceability, and make better use of health data, real-world evidence and analytical tools. These improvements could help reduce the administrative burden on industry while giving regulators and the wider health system a clearer picture of how technologies perform in practice.

The strategy also emphasises operational excellence and more transparent performance reporting, (although many of the detailed examples concern medicines and clinical trials). For this to be truly helpful, HealthTech companies will need equivalent service standards and metrics across registration, regulatory advice, vigilance, recognition and reliance and any future assessment or licensing functions. Reporting should show the experience of companies in practice, not only compliance with statutory deadlines. 

MHRA intends to modernise patient and product information through structured digital content. This could create an opportunity to further our position on electronic instructions for use and digital labels for HealthTech. Proportionate implementation could give patients and professionals easier access to current information, reduce avoidable burden and align the UK more closely with international practice. 

AI and the Future of Lifecycle Regulation

AI is the most developed HealthTech theme in the strategy, and the MHRA plans to support implementation of the 44 recommendations from the National Commission into the Regulation of AI in Healthcare. The published plans include expanded Predetermined Change Control Plans, continuous monitoring of real-world performance, exploration of foundation model Master Files and an MHRA Centre for AI and Digital Health. 

These measures provide an early test of lifecycle regulation, but change management is not solely an AI issue. Software, connected products, conventional devices and IVDs also need workable approaches to modification, evidence and post-market assurance. 

The strategy also refers to proposed powers for MHRA to undertake regulatory assessments directly, subject to the UK Parliamentary process. The final model remains to be defined, including the relationship between MHRA, Approved Bodies and recognition and reliance routes. 

ABHI's Priorities for Implementation

ABHI will continue to engage with MHRA, government and wider stakeholders on the practical issues that will determine whether the strategy improves the UK environment for HealthTech. Our priorities include implementation of CE recognition and international reliance, HealthTech service standards, registration and reporting infrastructure, eIFU and digital labelling, the AI Commission recommendations and development of new licensing powers. 

Throughout the rest of 2026 and into 2027, ABHI’s Medical Device and IVD Regulatory Groups will continue to provide regular forums for members to examine emerging proposals and develop industry positions. Member webinars and briefings will support timely discussion as policy detail emerges. Next year’s June Regulatory Summit will be an opportunity to meet in person to share experiences and practical scenarios, while this year’s annual HealthTech Conference in November will bring together industry, MHRA and other system partners to consider how regulation can support investment, innovation and patient access. 

From Strategy to Delivery

The MHRA strategy sets a positive direction, but success will depend on delivery and implementation. A true measure of MHRA success will include whether HealthTech companies in the UK experience clearer routes to market, predictable cost-effective services, modern regulatory infrastructure and proportionate lifecycle regulation across medical devices, IVDs and digital health. 

Steve Lee, Executive Director, Regulation, ABHI

MHRA Strategy 2030 - the main agency strategy and delivery priorities. 

MHRA Strategy to 2030: What it means for you - supporting sector explainers, including HealthTech. 

MHRA strategy blog series - GOV.UK - influential voices on the challenges and opportunities ahead.