The UK Life Sciences Council has issued a statement concerning their agreement to publish proposals to accelerate the delivery of the future UK HealthTech regulatory system. The statement comes against the backdrop of larger regulatory reforms for medical devices in the United Kingdom. Back in September 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a consultation concerning the future regulation of medical devices in the UK. The Government’s response to this consultation was published in June 2022 and new medical device regulations based on its findings are expected in spring 2023.
The Life Sciences Council’s statement outlines its intention to issue proposals on three priority areas which will support the delivery of the new regulatory system. These three priority areas are:
- International recognition
- Routes for innovation
- System capacity
The first priority area – international recognition – concerns the UK’s recognition of medical device approvals granted in other trusted regulatory jurisdictions. The proposals are expected to further address how the recognition of foreign approvals would reduce the burden on industry and the regulatory system. Compared to other countries, the UK lags behind in its system of international recognition. As an official observer (but not a member) of the Medical Device Single Audit Program (MDSAP), manufacturers are unable to use certificates granted in other regulatory jurisdictions as a means to market their products in the UK. This is, however, expected to change once the new regulatory system is in place as the Government’s MHRA consultation response notes plans to utilise MDSAP certificates as alternative routes to market in the UK for manufacturers.
The second priority area concerns pathways for innovative med-tech products. This, again, was raised by the MHRA’s consultation and the Government’s response noted an intention to establish new routes to market for innovative products. Importantly, the Government’s response acknowledged concerns regarding stringent safety measures, and stated that the new route would be limited to specific, defined, circumstances. It is hoped that the Life Sciences Council proposals will elaborate on these circumstances.
Initial proposals on all three priority areas are expected in February 2023, and we will be keeping a close eye on the situation, so follow our blog to stay current with recent developments!
