The MHRA has published its ‘Roadmap’ to reform the regulation of Software and AI as a Medical Device in the UK. The Roadmap gives Tech and Healthcare companies details of the steps MHRA intends to take to make the UK a more attractive global destination for Software and AI medical devices.

While companies looking to bring Software and AI medical devices to market will need to wait for the detail of the new guidance and legislation to fully understand the changes (with first drafts expected by the end of 2022), the Roadmap provides a good insight to the timescales and types of change which businesses may need to make to ensure profitable implementation and compliance.

The Roadmap sets out various work packages, each with objectives and deliverables, intended to address issues identified within MHRA’s Software and AI as a Medical Device Change Programme (the “Change Programme”). The Change Programme has been developed from recent consultations on the UK’s medical device regulatory framework, the latest step in the range of measures aimed at implementing the Government’s Life Science Vision.

This update picks up some of the key themes and expected changes.

Key Themes

The three key themes of the Change Programme, which speak to the pillars outlined in the Government’s Life Sciences Vision and the response to consultations, are ensuring:

1. The requirements for software and AI as a medical device provide assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public. The requirement for assurance that software and AI as a medical device is safe and functions in a manner that is both public and patient-centric.
2. The requirements for manufacturers are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards. The need for greater clarification and streamlining of manufacturer requirements and required processes.
3. The friction is taken out of the market by working with key partners such as the NICE and NHS England to align domestically, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. Internationally, working with other regulators both bilaterally, and multilaterally through the International Medical Device Regulators Forum (IMDRF) to strengthen international convergence and consensus on software and AI products.

The Changes to Come

The Roadmap sets out the expected pipeline of changes to secondary legislation and new guidance. These are to be released in tranches, with the aim to provide first drafts in some areas by the end of 2022.

Some key areas of reform include:

• Defining SaMD: clarifying what qualifies as software as a medical device (SaMD). This includes issuing guidance in regards to the creation of appropriate intended purposes for SaMD and identifying the manufacturer.
• Classification of SaMD: reforming the classification rules for SaMD to mirror the real risk of the relevant device and align with international standards.
• Airlock process: a potential ‘airlock process’ could enablefor SaMD intent on providing faster access to UK markets where novelfor novel devices that lack the required evidence needed for the premarket stages, by providing a limited period of monitored market exposure to accumulate data. This proposal would require a further consultation with Government if it is to be pursued.
• Access to UK market: making premarket requirements clearer and more appropriate for SaMD and AI to enable a ‘smoother path’ for manufactures to bring products to market.
• Adverse incident reporting: clarifying reportable adverse incidents in the context of SaMD and AI, including what events would be covered, reporting process and next steps.
• Cyber security: updating guidance to provide protection against cyber security and establishing more applicable visible and accessible means of reporting cyber security incidents.
• AI: highlighting the 10 guiding principles of good machine learning practice (GMLP) and issuing a standards mapping document to supplement the GMLP principles as a means of achieving greater international harmonisation, while correct and ensuring AIaMD is safe and effective.
• Human interpretability: issuing guidance on the potential for human interpretability within AI whilst supporting wider work on establishing a framework to ensure safe and effective AIaMD.

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.