In November 2022, the Life Sciences Council acknowledged that the development of new sovereign arrangements for the regulation of medical devices presented a golden opportunity to drive innovation and growth in the UK, whilst ensuring patient safety remains at the heart of the UK’s regulatory approach. Following the publication of a Joint Statement in December 2022, the Advisory Group was formed to provide initial proposals to government in three priority areas: international recognition; routes for innovation; and system capacity.
The Group has taken a patient centred approach, with patient safety and maintaining access to existing and novel products at the core of its discussions. The following detail is a minute of the final Advisory Group discussion.
Advisory Group Meeting Minute – Reform Proposals
The ambition continues to be to ensure the UK is the first place innovators bring novel HealthTech for approvals and to develop a best-in-class regulatory system that assures and enhances patient safety. The Group agreed the need for these reset proposals to create a step change in the approach to regulation. This builds on the principles in the Taskforce on Innovation, Growth and Regulatory Reform (TIGRR) report to support innovation with proportionate, Outcomes Based Collaborative Regulation. The future work needed should take into account the wider Government work on medicines legislation and the Sir Patrick Vallance Project on the Pro-Innovation Regulation of Technologies.
The Group focussed on three, interrelated areas: international recognition, routes for innovation and system capacity. Over the course of the last 8 weeks, the Group agreed that there is a once in a generation opportunity to make a change. The Group agreed that their joint ambition is to make rapid and significant progress in the approach to the three areas and the resulting proposals have the potential to provide world class support for innovators and best in class protections of patient safety.
On international recognition, the global regulatory context was discussed. The Group agreed there is an opportunity to enable transformative products to get to patients safely and more quickly. For this there needs to be a system of proportionate regulation which considers, and where appropriate, recognises the decisions of other trusted regulators. This will accelerate patient access to many safe, effective devices; create regulatory space and time for novel, complex innovative products; and reduce duplicative and unnecessary regulatory burden on companies, especially Small and Medium sized enterprises.
On routes for innovation, the Group discussed the need to ensure early engagement with innovators of novel products. This should build on the work already in progress to support innovation, including the progress made to date on the Innovative Devices Access Pathway and the AI Airlock. It was agreed that where possible, this work should be used to showcase the UK’s ambitions for an innovative regulatory system – ensuring that NHS patients can benefit as quickly as possible from safe, innovative products with the potential to improve their clinical outcomes.
To support system capacity, there is a clear need to ensure there is sufficient regulatory expertise to support HealthTech through the regulatory process. Improving this is an endeavour shared between the public and private sectors, and must be done with due regard to efforts underway internationally and regulatory independence.
The reset proposals discussed throughout the Group’s meetings were significant and as such require further detailed policy development and impact assessment. In addition, the MHRA will further develop, and publish a roadmap, setting out the regulatory infrastructure required to drive innovation and ensure patient safety.
The Group set out their commitment to driving forward this work and agreed that a suitable governance process, including a phase two advisory group with a focussed Terms of Reference, should be set up to ensure momentum is maintained and the work needed to assess the aligned proposals is carried out and completed by the end of April.
To help create a system wide UK integrated pathway for HealthTech, MHRA to become a more responsive regulator with supportive innovation pathways
1. Consider expanding the role of the MHRA in the direct regulation of HealthTech, focusing initially on innovation.
2. The MHRA and other health system partners will need access to a robust international horizon scanning capability to proactively seek innovation. Work should be done in partnership with health system partners, academia and industry to identify relevant horizon scanning capabilities.
3. Develop a model for expanded bespoke pre-market regulatory advice for novel/innovative products.
4. Expand the use of Real-World Data to transform clinical investigations and performance studies by enabling earlier access when planned with proportionate post-market surveillance.
5. Develop performance metrics for support and uptake of HealthTech Innovation in the UK.
Ensure the supply of safe medical devices to UK patients is maintained through expanded recognition (e.g. to US approvals) and removing burden where possible
6. Building on current product recognition routes from the EU, rapidly explore building a UK product regulation equivalence route for the approvals of medical devices to include other trusted jurisdictions such as the US for a greater proportion of products.
7. Explore greater flexibility over the requirements for physical UKCA markings on parts, instructions and labels before products can be marketed in the UK. Make greater use of registration and traceability mechanisms to ensure patient safety.
8. The MHRA has already announced its intention to expand recognition for medicines, and create a new recognition framework by the end of 2023. Aim to align changes to the Medical Devices Legislation to the Medicines legislative timeline if possible.
Ensure the future system is enabled, and avoids current challenges, through the development of a UK regulatory skill programme
9. Explore delivering a UK HealthTech Regulatory skills programme.
10. Investigate investing in the delivery of a UK network of Centres of Excellence in Regulatory Science and Innovation (CERSIs).