UK Regulatory Agency Releases Guidance on AI and Software as Medical Devices

The Medicines & Healthcare products Regulatory Agency (MHRA) released guidance on software and artificial intelligence (AI) as medical devices on April 6, 2023. The Software Group, responsible for ensuring the safety of software as a medical device (SaMD) and AI as a medical device (AIaMD), aims to assure the public has access to clinically necessary technology.

The guidance addresses various aspects of SaMD and AIaMD, including pre-market and post-market enquiries, technical file reviews, clinical investigation and exceptional use authorisation, and engagement with stakeholders. The MHRA also aims to ensure medical device regulation is fit for purpose and supported by robust guidance.

Manufacturers and researchers are advised to consult the MHRA's guidance on classifying software as general medical devices or in vitro diagnostic medical devices (IVDs). The Software Group has provided specific advice on software used during the COVID-19 pandemic, as well as information on the Health Institution Exemption (HIE).

The MHRA has planned an extensive Change Programme and supporting Roadmap to drive regulatory changes across the SaMD lifecycle, including qualification, classification, and pre- and post-market requirements. This programme will address the challenges and opportunities posed by AIaMD, focusing on evidence, transparency, explainability, interpretability, and adaptivity.

The Software and AI as a Medical Device Change Programme Roadmap, published on October 17, 2022, provides further information on the Change Programme's work packages, deliverables, and implementation.

The MHRA has also collaborated with international regulators, academic groups, and UK health organisations to advance software and AI medical device regulation. Partnerships include work with the International Medical Device Regulators Forum, the AI and Digital Regulations Service for Health and Social Care, and NHS England.