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.
To help create a system wide UK integrated pathway for HealthTech, MHRA to become a more responsive regulator with supportive innovation pathways
- Consider expanding the role of the MHRA in the direct regulation of HealthTech, focusing initially on innovation.
- 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.
- Develop a model for expanded bespoke pre-market regulatory advice for novel/innovative products.
- 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.
- 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
- 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.
- 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.
- 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
- Explore delivering a UK HealthTech Regulatory skills programme.
- Investigate investing in the delivery of a UK network of Centres of Excellence in Regulatory Science and Innovation (CERSIs).