At the recent British Healthcare Trades Association (BHTA) Conference 2024, Laura Squire, Chief Healthcare Quality & Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA), discussed where UK medical device regulation is at now and what the future looks like.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Laura began by explaining the MHRA’s purpose in delivering the future regulatory framework of medical devices in the UK. Its goal is to deliver a robust and leading regulatory framework that prioritises patient and public safety. In delivering this regulatory framework, the MHRA’s chief goals are to deliver:
The new regulatory framework has been implemented via a series of Statutory Instruments (SIs), Laura explained. Further details are in the slide below.
Laura also provided details of where MHRA is at now with UK medical devices regulation and plans for 2024-2025. The slides below provide more information.
“We’re trying to be more transparent about our timescales,” Laura commented. “But it’s very difficult to be transparent about timescales when you’re doing legislative work, because there are certain things that are not within our gift in terms of timescales.”
A key point from Laura’ presentation was around international recognition. MHRA recently published a statement of policy intent, which outlined MHRA’s intention to recognise medical device approvals from Australia, the EU, Canada, and USA. It contained further details for the access routes depending on the device type, class, and prior approval.
“We are also working actively with Japan to bring them into the international recognition,” added Laura. “It’s slightly more complex there because of the population and understanding how they apply some of the international standards, but there is no doubt that Japan is a rigorous regulator, so we would trust it.
“We’re calling these comparable regulators, because I don’t like the phrase ‘trust’. It implies we don’t trust everybody else, and we do trust quite a lot of other regulators. It’s about the practicalities of making it work. At the moment, these countries are the ones that we think we can get to work, and we’ve worked with all these countries to try to design the framework.”
MHRA is testing the proposed framework in collaboration with industry and approved bodies, using a range of devices with existing approvals from these countries. Market access via international recognition would only be formally granted once the future core regulations are in force, Laura explained. The proposed framework may be updated based on these activities.