The MHRA has published guidance on the use of Software and Artificial Intelligence (AI) as a Medical Device.

The guidance provides access to outputs of the MHRA’s Software Group, which is responsible for developing the regulatory changes which will govern Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD).

The guidance builds on the MHRA Roadmap for Change by providing links to resources which MHRA says will be “updated as required”. So while the new guidance doesn’t contain any substantive changes to the regulatory framework at this stage, it provides an introduction to the Software Group and highlights where further guidance can be found in each of the following areas:

• Classifying software as a general medical device or an IVD (in vitro medical device);
• The UK Regulatory Framework for SaMD;
• Intended use statements for SaMD and AIaMD;
• Post-market surveillance and vigilance, including adverse incident reporting;
• Guidance on Good Machine Learning Practice (GMLP) for medical devices; and
• The Software Group’s key regulatory partners.

If you would like to discuss how the current regulatory regime or future changes might impact you or your products, please contact our Healthcare team.

This article was written by Rory Trust and Sasha Anisman.