On 17 October 2022, the MHRA published a “roadmap” for its Software and AI as a Medical Device Change Programme.
The Change Programme was originally published in 2021, setting out a promise to deliver “bold change” to the UK regulation of Software as a Medical Device (“SaMD”) and AI as a Medical Device (“AIaMD”). What that work programme didn’t do was set out how the MHRA intended to achieve the various objectives it had set itself.
Enter the roadmap. In the roadmap, the MHRA explains exactly what deliverables we can expect to implement the change programme. In some cases this will be through secondary legislation, as referenced in the MHRA’s response to the consultation on medical devices published in June. However, the bulk of the deliverables will be in the form of guidance – in fact, in the roadmap the MHRA commits to producing 18 separate pieces of guidance, whether alone or jointly, e.g. with the Health Research Authority.
Effecting the changes as guidance rather than legislation means the MHRA can (in theory) be faster in getting the change out to industry, and more agile in terms of updating and developing the rules over time. The guidance won’t be legally binding, but historically has been informative and fleshed out the bare bones of legislation which is usually drafted more with physical devices in mind.
The guidance will cover a range of topics, including the fundamentals of what qualifies as SaMD. The MHRA already has detailed guidance in this area, but the field is developing fast and there are inevitably gaps between the technology available and the examples provided in the existing guidance. Guidance on who is the legal manufacturer for SaMD will also help businesses assess their legal risk, particularly for software deployed via third party websites.
Some of the guidance is intended to be published in draft before the end of the year. This will include guidance on intended purpose – the “cornerstone” of medical device regulation. Interestingly, this guidance will also cover how intended purposes can be expanded, which can happen organically with SaMD as the technical capabilities of the product develop, but not something often discussed in the context of traditional devices.
The MHRA has also committed to exploring an “airlock process” for SaMD, to address the issue that some manufactures cannot generate the necessary evidence in the premarket phase. Under the airlock process, manufacturers would be allowed to use the software to generate real world evidence for a limited time, while being continuously monitored, to allow early access to the UK market for novel SaMD.
On the AI side, the MHRA intends to effect changes through guidance, standards development and experimental work (rather than through legislation). The guidance will address issues such as ensuring the representativeness of data used to train AI models to try and manage and mitigate bias. Bias is openly accepted as a real issue in AI – tools can either cut through bias or reproduce it, depending on the quality of the training data used. The first draft of this guidance is expected to land before the end of 2022.
Other broad areas include AI interpretability and AI adaptivity.
The MHRA has clearly recognised the need from industry for clarity in this area. It has set itself a goal of becoming a world-leading regulator for SaMD and AIaMD – encouraging innovation and making the UK an attractive place to launch such devices post-Brexit. All of this must be balanced of course against patient safety.
When the MHRA promised it was “going big” on guidance at the recent ABHI regulatory conference, this was not an understatement. It has certainly come a long way since its first guidance in this area which only ran to a few pages. The issue is ensuring that all this guidance keeps pace with the technology and the needs of manufacturers in such a fast developing-area. The MHRA will also need to balance its ability to forge ahead as a sovereign regulator against the need not to deviate too far from regulators globally, to ensure compliance with UK regulation does not amount to an additional burden that manufacturers might choose to avoid.
We look forward to reviewing the first tranche of guidance when this is published later this year.