UK plans new regulatory framework for AI medical devices

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is preparing a new regulatory approach for artificial intelligence and medical technologies. At the AdvaMed 2026 conference, the regulator outlined plans for more flexible oversight of AI-enabled medical devices, closer cooperation with international regulators and stronger monitoring throughout a product's lifecycle. The reforms are intended to accelerate access to innovative technologies while maintaining patient safety.

The plans form part of the recently published MHRA 2030 Strategy, which sets out how the UK intends to modernise the regulation of medicines and medical devices. A central ambition is to develop a regulatory framework that can respond to AI systems whose performance and functionality may change after they have entered clinical practice. Speaking at AdvaMed on 20 October, Jessica Paulsen, MHRA Deputy Director for AI and Software, explained how the regulator intends to translate these ambitions into practical measures.

Regulation throughout the AI lifecycle

Traditional medical device regulation is largely designed around products with relatively stable characteristics. AI-enabled medical technologies introduce additional challenges because algorithms may be updated, adapted or perform differently across patient populations and healthcare settings. The MHRA therefore wants to move towards a more proportionate, lifecycle-based regulatory approach. This would place greater emphasis on monitoring performance and safety throughout a product's use, rather than concentrating primarily on its initial approval.

The strategy includes plans to establish an MHRA Centre for AI and Digital Health, bringing together regulatory expertise to provide clearer guidance for developers of AI-driven medical devices and digital health technologies. The regulator is already exploring new approaches through AI Airlock, a regulatory sandbox in which developers and regulators examine challenges associated with AI medical devices in a controlled environment.

Regional partnerships with NHS London and Manchester University NHS Foundation Trust will complement this work. These collaborations are intended to generate evidence from healthcare settings and help determine how future regulatory requirements should be structured. The policy direction also reflects recommendations from the independent National Commission into the Regulation of AI in Healthcare. The UK government has accepted all 44 recommendations, including proposals for proportionate oversight, clearer responsibilities and continuous evaluation of AI systems.

According to Paulsen, regulation must evolve alongside medical technology. She emphasised that initiatives such as AI Airlock are helping the regulator develop practical approaches that balance innovation with patient protection.

Closer cooperation with the FDA

International regulatory cooperation is another important component of the MHRA's plans. The UK regulator wants to strengthen its relationship with the US Food and Drug Administration (FDA), particularly in areas involving AI and emerging medical technologies. The MHRA-FDA Pioneer Programme, announced in June 2026, establishes reciprocal liaison positions within both organisations. These roles are intended to improve communication, scientific exchange and coordination on regulatory challenges. The MHRA is recruiting a Regional Deputy Director of US Partnerships, based in Washington, DC, who will act as its dedicated liaison officer to the FDA.

The initiative builds on earlier commitments to reduce regulatory barriers between the UK and US medical technology markets. Greater alignment could make it easier for manufacturers to navigate regulatory requirements in both countries. However, closer cooperation does not mean that regulatory decisions will automatically be recognised across borders. Both agencies will retain their independence in assessing the safety and effectiveness of medical products. The MHRA is also exploring broader international recognition and reliance mechanisms, including pathways involving medical devices already assessed by trusted regulators.

Innovation and patient safety

Alongside AI-specific reforms, the MHRA is pursuing wider changes to medical device regulation. These include improvements to post-market surveillance, better device data and traceability, and proposed legislative changes intended to make the regulatory system more responsive. The agency aims to establish what it describes as a global standard for safe and agile regulation of medical technology and AI by 2030.

For healthcare providers, the proposed direction places greater importance on understanding how AI systems perform after implementation. Monitoring real-world outcomes, identifying changes in performance and clarifying responsibilities will become increasingly relevant as AI applications are integrated into clinical workflows. For developers, clearer regulatory expectations and more flexible approaches to product updates could reduce uncertainty during development and deployment.

Nevertheless, many elements of the strategy remain proposals or initiatives under development. Their practical impact will depend on subsequent regulatory decisions, implementation and the evidence generated through programmes such as AI Airlock. he central challenge for the MHRA is therefore not simply to accelerate innovation, but to establish regulatory mechanisms capable of maintaining safety and effectiveness as AI-enabled medical technologies continue to evolve.