The Government has provided further details on its reform of medical device regulation, confirming its commitment to encouraging international investment, innovation and improving safety in the UK. The Department for Health and Social Care published its response last week to recommendations made in an independent report on the UK’s approach to regulatory changes following Brexit.
The Government accepted all 11 recommendations made by the Regulatory Horizons Council (RHC), providing further detail on how the UK can encourage international investment, innovation and improve safety for medical devices. It builds on the programme of reform set out in the response to the MHRA’s consultation on the future of medical device regulation and the MHRA’s associated Roadmap for delivering these reforms in relation to Software and AI, which was published in October 2022. For further information, please see our post on the response to the MHRA consultation and our post explaining the Roadmap.
We set out the RHC recommendations below, and while the response does not signal any radical changes to the expected reforms, it does confirm the Government's desire to make the UK a leading destination for life sciences companies looking to bring innovative products to market. While it remains to be seen exactly how and when the programme of regulatory reform will be delivered, the Government believes the UK is well-placed to exploit the opportunities provided by Brexit (and build on the success of the UK Vaccines Taskforce at the start of the Covid pandemic) in order to deliver the Government's Life Sciences Vision.
We are currently waiting for the response to the RHC’s latest report, focused on the Regulation of AI as Medical Device, published at the end of 2022. The RHC AI report made a series of further recommendations, based on a gap analysis of the current UK regulatory regime, the MHRA Roadmap and comparison with international approaches. If the support for the RHC’s recommendations on medical device regulation in general is any indication, the RHC’s AI report is recommended reading for those wanting to understand how AI as a medical device may be regulated in the UK in future.
In their latest response, the Government either accepted in full, or in principle, each of the recommendations made by the RHC which are set out below. You can read the original report here and the Government response in full here.
Recommendations of the Regulatory Horizons Council and Government response
1. The regulation of medical devices should be centred on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patients.
2. Strengthen and increase funding to the MHRA to significantly expand their capacity in medical devices, including in emerging technologies.
3. Address bottlenecks in the approval of medical devices, notably the shortage of UK approved bodies for conformity assessment.
4. Prepare mitigations that supplement UK approved bodies capacity to ensure supply of devices after transition to UKCA.
5. Support the MHRA to increase UK visibility, international engagement and leadership.
6. Invest in the UK as a global centre for regulatory science and the training of regulatory professionals with expertise in medical devices, including in emerging technologies.
7. Build international partnership through mutual recognition and reliance or assurance where this may lead to overall efficiencies while preserving safety.
8. Identify and resource areas where regulatory innovation within the medical device sector may attract inward investment and growth.
9. Develop a UK patient safety database that collects key details of all medical devices and monitors patient safety and wellbeing moving forward.
9A. Strengthen existing safety reporting through digital tools and the use of comprehensive data collection from health systems, patients and carers to a central MHRA-held UK patient safety database.
9B. When medical devices are used, their unique device identifier should be recorded as standard within a patient’s health record, and this should be returned to a central MHRA-led UK patient safety database.
10. Pandemic preparedness should include fast-track evaluation of new In Vitro Diagnostics.
11. Reporting of diagnostic tests should be transparent and standardised.
If you would like to discuss how the current regulatory regime or future changes might impact you or your products, please contact our Health Tech team.
This article was written by Rory Trust and Callum Duckmanton.
Following the UK’s withdrawal from the EU and the MHRA's consultation on the future regulation of medical devices, the government is well placed to take forward the report’s recommendations and deliver a world-leading regulatory framework – Government response