Introduction
Artificial intelligence (AI) is transforming healthcare and medical technology. In the UK, there is significant interest and investment in leveraging AI to improve patient outcomes.
Use cases
Some promising use cases for AI medical devices include:
- Diagnostic support: systems that analyse medical images, patient symptoms and test results to provide doctors with diagnostic recommendations or risk assessments. Examples include systems for detecting diseases in x-rays, MRIs and ophthalmology scans.
- Clinical decision support: AI algorithms that leverage large datasets of patient health records and biomedical information to provide patient-specific treatment recommendations. These can optimize medication dosing, surgery planning and discharge protocols.
- Patient monitoring and deterioration detection: machine learning models that continually monitor vital signs and biomarkers from bedside devices or wearables to provide early warning scores and detect subtle signs of patient decline or adverse events.
Regulation
The regulatory landscape in the UK for AI-based medical software continues to evolve, with oversight by the Medicines and Healthcare Products Regulatory Agency (MHRA). Many software and AI products are regulated, either as a general medical device or as an in vitro diagnostic medical device (IVD), meaning that software as medical device (SaMD) and AI as medical device (AIaMD) products must meet requirements around risk assessment, clinical validation, transparency, user interfaces and continuous monitoring through their lifecycle.
Most SaMD and AIaMD products regulated under MHRA guidelines are classified as lower risk, allowing self-declaration of conformity by manufacturers. Higher risk applications go through additional MHRA assessment and review, and face more extensive requirements throughout their lifecycle.
The MHRA’s Software Group has responsibility for all SaMD and AIaMD placed into the UK market. The goal is to ensure safety and performance while enabling rapid innovation. Key responsibilities carried out by the Software Group include:
- Assisting with pre-market and post-market enquiries from manufacturers.
- Conducting technical file reviews and post-market surveillance activities.
- Reviewing technical and clinical aspects of clinical investigations and exceptional use authorisations.
- Ensuring medical device regulation is fit for purpose, meets the needs of software as well as AI, and is supported by robust guidance.
- Engaging with stakeholders including industry, healthcare organisations and professionals.
Future outlook
The UK’s health system is likely to see expanded use of AI in areas like triage chatbots, personalized medicine, automated radiology and smart hospitals. However, there remain challenges around transparency, explainability of model decisions and appropriate human oversight. Regulators continue to adapt policies to balance innovation with stringent health technology assessments. Key enablers will be access to large high-quality datasets for analytics, improved clinical integration workflows and public trust building.
With this in mind, the MHRA recently announced plans for an extensive Change Programme and supporting Roadmap to drive regulatory changes including key reforms across the SaMD and AIaMD lifecycle, from qualification and classification to requirements that apply both pre and post-market. Given the challenges and opportunities posed by higher risk AIaMD, the programme also seeks to ensure that these devices are appropriately evidenced, while also addressing wider issues of transparency of AI (both explainability and interpretability), and adaptivity (retraining of AI models).
Conclusion
The UK has emerged as a global leader in harnessing AI to improve patient care while upholding strict regulatory standards. As algorithms continue to mature, medical AI promises earlier disease detection, reduced clinician burdens and more personalized evidence-based care tailored to the specifics of each patient. Close collaboration between technology innovators, healthcare providers and regulators will be vital to delivering safe and effective AI-enabled solutions that improve patient outcomes.
For more information, please contact Tim Wright or your usual Fladgate contact.
