United Kingdom: The Medicines and Healthcare Regulatory Agency publishes its “roadmap” for Artificial Intelligence and software as a medical device

In brief

The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD) and software as a medical device (SaMD). This will form part of the basis of the upcoming UK Medical Device Regulation reforms in 2024.

In light of the operational difficulties faced by the NHS, AIaMD and SaMD are attractive solutions to alleviate pressures on the UK health system. Yet these products are complex and require a high level of regulatory scrutiny to ensure effectiveness and protect the safety of patients.

The MHRA has designed a series of work packages which identify the issues and deliverables required to address these issues. The core aims of the work packages are to bring the UK MDR in line with the practical day-to-day needs of AIaMD and SaMD where the current regulations fail to do so, and to provide clarity for manufacturers. Each work package should not be viewed in isolation but rather work together to ensure the safety of AIaMD and SaMD for use in Great Britain.


Key takeaways

The key takeaways from each work package are:


  1. Qualification: Providing clarity to manufacturers regarding what qualifies as a SaMD.
  2. Classification: Classifying software proportionate to the risk that it might pose to the patient and public safety.
    • Airlock process: The MHRA also understands that some manufacturers are unable to generate the level of evidence required in the pre-market phase. As a result, the government may explore an “airlock process” to address this issue for SaMD products.
  3. Pre-market requirements: Aims to clarify the pre-market requirements for SaMD. There will also be a best practices guide to highlight areas where current “best practice” may not meet the regulatory definition of the “state of the art”.
  4. Post-market requirements: The MHRA will produce guidance to clarify what constitutes as an adverse incident and clearly set out the reporting requirements when such incidents occur or where there is a risk of incidents occurring. In addition, there will be guidance for processes in place for change management which does not compromise patient safety.
  5. Cyber security: The future UK MDR aims to better accommodate and adequately consider cyber security risks and the MHRA will publish guidance on the reporting requirements of cyber security issues.


  1. AI RIG (AI Rigour): AI RIG seeks to address the lack of clarity on the use of AI for medical devices. This includes developing guidance on good practices in machine learning and limiting bias in AI to ensure AIaMD is suitable across all sections of the population.
  2. Project Glass Box (AI Interpretability): Project Glass Box will ensure that adequate consideration is taken of human interpretability and its consequences for safety and effectiveness in AIaMD products.
  3. Project Ship of Theseus (AI Adaptability): This involves updating the requirements and processes around the notification and management of change to fit AIaMD.

The roadmap is a step towards providing greater clarity on how UK MDR will seek to keep up to date with the pace of SaMD and AIaMD development. However, manufacturers will be particularly eager to see the drafts of how the roadmap will be implemented and whether these consider the practical workings of SaMD and AIaMD to facilitate innovation while also protecting patients.

The UK government press release is available in full here.

For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.

Copyright © 2023 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.