Introduction
The UK government is actively reforming medical device regulations [2], with a particular focus on software and AI products [2]. This initiative aims to balance innovation with patient safety, ensuring that the regulatory framework remains effective and relevant in the face of emerging technologies.
Description
The UK government is reforming medical device regulations [2], particularly focusing on software and AI products [2], as outlined in a public consultation response from June 2022 [2]. The government has accepted all 15 recommendations from the Regulatory Horizons Council regarding the regulation of AI as a medical device (AIaMD) [4], which includes a commitment to ensure the Medicines and Healthcare products Regulatory Agency (MHRA) is adequately funded to develop an efficient and safe regulatory framework [4]. The MHRA is developing regulatory guidance to assist manufacturers in complying with new legislation [2], emphasizing safety [2], innovation [1] [2], and patient outcomes [2]. To keep pace with emerging technologies [1], the MHRA is also creating dynamic guidance to ensure that regulations remain effective and relevant [1].
Generative AI presents opportunities in healthcare [2], necessitating a balance between innovation and patient safety [2]. A review of generative AI’s impact on the NHS is being commissioned to facilitate AI adoption through innovative regulation [2]. The MHRA is advocating for long-term funding to enhance its regulatory framework for AI medical devices [2].
In May 2024 [1], the MHRA introduced the AI Airlock [1], a regulatory sandbox designed for AI-based medical devices [1], which will operate until April 2025 [4]. This initiative invites applications from developers of AI-based medical devices [3], as defined by the UK Medical Devices Regulation 2002 [3]. Applicants must be legal entities with marketing rights in the UK and are required to collaborate with the AI Airlock throughout the pilot [3]. The initiative aims to address regulatory challenges and inform future policies [2], with five new AI-powered medical technologies selected for pilot testing in areas such as cancer and chronic respiratory diseases [4]. Each testing plan will be tailored to the specific product, and candidates should anticipate completing their individual Airlock testing within six months [3], in line with emerging global best practices [3]. The MHRA is expanding its regulatory capacity for AIaMD [2], focusing on pre-market and post-market phases [2], and is committed to producing guidance for manufacturers on evaluating risks related to AI bias and generalisability [2].
Manufacturers are required to provide evidence of the interpretability of AI outputs and to ensure that AIaMD products are safe for their intended use environments [2]. They must collaborate with health institutions to demonstrate the safety and performance of AIaMD in local settings before deployment [4]. Clinical validation data is essential for assessing the accuracy [1], reliability [1] [3], and clinical relevance of AI and machine learning algorithms in digital health solutions [1]. The regulatory framework aims to support innovative mechanisms for accelerated access while enhancing post-market surveillance [2].
Collaboration among stakeholders is essential for effective post-market monitoring and optimizing AIaMD performance [2]. The MHRA is developing a streamlined process for safely deploying AIaMD products within the NHS and emphasizes the importance of contractual agreements for monitoring performance and safety [2]. Stakeholders must work together to establish standards for post-market monitoring [4], and agreements on monitoring and safety responses should be included in contracts between health institutions and manufacturers [4]. The Information Commissioner’s Office (ICO) will assist the MHRA AI Airlock by providing data protection advice to applicants, which can be requested during the application process [3].
Manufacturers must have withdrawal plans for their products [2], and the MHRA is committed to clear communication of the regulatory pathway for AIaMD [2]. The agency is investing in guidance to assist small and medium-sized businesses in navigating medical device regulations [2]. There are no fees for applicants during the pilot [3], but candidates must commit resources to the program [3], including funding their own studies and Airlock testing [3], as well as accessing necessary data sets [3].
Public trust is a priority [2], with efforts to enhance patient and public involvement in the design and evaluation of AIaMD [2]. The UK aims to lead internationally in AIaMD regulation [2], promoting harmonization and efficiency in regulatory practices through collaboration with global regulators [2], including the FDA and Health Canada [4], and developing an international reliance framework to streamline access to medical devices and minimize regulatory duplication [4]. Key themes include the necessity for transparency and explainability in AI systems to ensure their safe and effective use as medical devices [3], as regulators emphasize the importance of AI systems that clinicians can comprehend and interpret [3], while also facing challenges in balancing regulatory requirements with the practical utility of these systems in clinical environments [3].
Conclusion
The UK’s efforts to reform medical device regulations, particularly for AI and software products, underscore a commitment to fostering innovation while ensuring patient safety. By enhancing regulatory frameworks and fostering international collaboration, the UK aims to lead in the global landscape of AIaMD regulation. This approach not only supports technological advancement but also ensures that emerging medical technologies are safe, effective [1] [2] [3], and trusted by the public.
References
[1] https://iclg.com/practice-areas/digital-health-laws-and-regulations/united-kingdom
[2] https://www.gov.uk/government/publications/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-rhc/the-regulation-of-artificial-intelligence-as-a-medical-device-government-response-to-the-regulatory-horizons-council
[3] https://www.gov.uk/government/publications/ai-airlock-pilot-cohort/ai-airlock-pilot-cohort
[4] https://htn.co.uk/2025/03/11/government-accepts-15-recommendations-on-the-regulation-of-ai-as-a-medical-device/
