In the recent budget announcement from Jeremy Hunt , it referenced the intension to enable the MHRA to sign-off medicines and technology already approved by trusted regulators from 2024. There is already Project Orbis – GOV.UK (www.gov.uk) which provides a framework for concurrent submission and review of oncology products among international partners. This is co-ordinated by the U.S. Food and Drug administration alongside MHRA and involves the regulatory authorities of:
- Australia (Therapeutic Goods Administration (TGA))
- Canada (Health Canada)
- Singapore (Health Sciences Authority (HSA))
- Switzerland (Swissmedic)
- Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))
Additionally MHRA together with the regulatory authorities of Australia, Canada, Singapore and Switzerland is part of the Access Consortium Access Consortium – GOV.UK (www.gov.uk) which is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
What might this have to do with Medical Devices?! I can hear you asking, neither of the groups above currently mention them. However, these could be seen to be setting the precedent, the closer ties that the UK government is building with the USA, Canada, Australia would immediately seem to be the most logical states to be considering when talking about approvals from trusted regulators. Additionally, with the MHRA official delay of the new UK Medical Device regulation out to June 2025 it gives IVD Device manufacturers to possible opportunity to look at a two pronged regulatory strategy for launch.
It may be wise for manufacturers looking to bring new devices to the market in the next couple of years to seriously consider forgoing the EU as the first port of call for registration approvals. The US FDA 510K/PMA process is a clear, well understood process which does stick to timelines unless real issues are identified during the review. The pre-submission process is a way for a manufacturer to gauge how the FDA is viewing the device and feedback, whilst not direct advice, allows adjustment before final submission. This allows the manufacturer to have the best opportunity for approval with as little too and fro as possible. For manufacturers who have an innovative device, the Breakthrough Device Designation programme may be to route to take Breakthrough Devices Program ¦ FDA.
By looking to bring devices to the UK market through the current UK MDR 2002 which is based around the IVD Directive requirements, allowing many manufacturers to self-certify, and simultaneously submit to the US FDA, two recognised regulatory approvals could be delivered within 6 months of file submission. EU IVD Regulatory approval should not be dismissed but for start-up organisations, where revenue is key, this approach would result in getting to market sooner and being more attractive for acquisition if that was an attractive proposition.
If you are interested in learning more around UK MDR support and or US FDA requirements please get in touch [email protected] or book a slot in my calendar