We are at that reflective time of year so there will be a lot of that in this edition, but also a seasonal gift in the form of our revised roadmap that sets out a more future view. Some of it was trailed in my last blog, but the roadmap also covers some of the areas of policy which are not impacted by changes in the law but where there are some exciting opportunities, to think about ‘what next’.
January 2024 seems like a very long time ago. We started by setting an ambition to improve our communication and transparency about what we are doing in the regulatory reform work. Part of this was the publication of a roadmap. That expired quicker than we expected, but the General Election mid-year gave us all the chance to reflect on the path we had been on since the 2021 consultation. In some ways that illustrates the risks of being so open with our plans, but openness still has to be the way forward.
Looking back at the year, February was the month when we announced the eight products moving into the Innovative Devices Access Pathway pilot; The IDAP pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. Developers of those eight technologies are receiving tailored regulatory and access support from the IDAP Partners, including pre-market support from the MHRA until the end of the pilot in March 2025. The IDAP Partners are evaluating the pilot and the insights gained, together with the MHRA plans for medical device regulatory reform, will be important in helping shape the future direction of any future pathways.
March was the month where we were delighted to release updated guidance on the application of IVDR to products in Northern Ireland, particularly for clinical investigations and performance studies. The team worked with colleagues in Northern Ireland to try to ensure the position was clear, after successfully taking the regulatory changes themselves through parliamentary debates at the end of 2023. March was also the month of the IMDRF meeting in Washington, which included a valuable workshop focused on International Recognition and Reliance.
As a result of a lot of work in April, in May we were able to release a number of key communications; an update on our plans for the AI Airlock, our statement of policy intent on recognising and relying on decisions from other regulators and a consultation on common specification requirements for In Vitro diagnostics.
When the election was called the work continued, including considering how we could reshape our delivery to ensure that we could set out our plans for new Ministers, regardless of which party would lead, at the same time as keeping up the pace, to give stakeholders the certainty they have been asking for.
In June joint guidance was published with our partners in US FDA and Health Canada on transparency for Machine Learning Medical Devices. In July we held a webinar for potential applicants for the AI Airlock, and also in that month, along with IDAP partners, we had one of our first events involving new Ministers. Baroness Merron, the Parliamentary Under-Secretary of State for Patient Safety, Women’s Health, and Mental Health, attended the Innovative Devices Pilot Expo which brought together MHRA, patient representatives and partners in NICE, DHSC, Approved Bodies and the NHS across the four nations of the UK.
A highlight of September was another IMDRF session, this time in Seattle where the work of our MHRA team in leading a new working group looking at Clinical Evidence for In Vitro Diagnostics was highlighted. October saw our Post Market Surveillance regulations put before Parliament. These were debated in November which was also the month when we launched our consultation into some of the pre-market policy changes we intend to include in legislation to put to Parliament next year.
The last months of the year have seen bumper outputs on Software as a Medical Device. The team working on a joint project with NICE to develop guidance on the qualification of digital mental health technologies as software as a medical device had two papers published in Digital Health Journal and The Lancet Digital Health in November, then in December we were able to announce the five products for AI Airlock pilot first cohort.
All through the year this drumbeat of delivery has been made possible by the fabulous MHRA team and I would really like to thank them for everything they have done. I would also like to thank all of you who have engaged with us through workshops, webinars and in writing to get us this far. We continue to attract great people to the Agency, for example filling all the available seats in the AI Airlock team, with some outstanding talent. We have lost people too, including our head of Software and AI, but we have a new appointment, and I am looking forward to introducing him to you in the new year.
So what does 2025 look like? In the new roadmap I go a little further than regulations, highlighting areas of policy development we would like to work on with you. The industry does not stand still so we need to keep evolving our guidance, pathways and even our regulations to ensure they remain fit for purpose, thinking for example about things like the NHS shifts that the government wants to achieve and how we need to develop our policy on health institutions to respond to that. Software as a medical device, including AI, will be critical to making those shifts and the roadmap shows some of the things you can expect from that part of the team. How we can encourage a UK first regulatory strategy is something that we will continue to work with you on.
I will end by taking this opportunity to wish everyone the best for the festive season, whatever that means to you personally. The team at the MHRA looks forward to another productive year in 2025.
https://medregs.blog.gov.uk/2024/12/11/festive-reflections-on-med-tech/
seen at 16:39, 11 December in MedRegs.Email this to a friend.