Today the UK government released additional details regarding: international recognition with other regulatory agencies; routes for innovation and system capacity. The update can be found: HERE
This appears to be a shift from 2-4 years ago, in which the global regulatory systems were becoming more complex, more expensive, more burdensome, and more siloed from one another. Now with the Swiss government voting to accept FDA products onto the market; the EU government voting to postpone the MDR transition period; and the UK’s new proposal, we see a trend toward easing access to market.
International Recognition
The Advisory Group agreed there should be a system to consider, when appropriate, the decisions from trusted global regulatory authorities. The aim is to help get devices onto the market faster and reduce the regulatory burden on manufacturers to refile duplicate information to multiple regulatory bodies – especially for small-to-medium sized manufacturers.
Solutions in consideration include:
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- Building on the current recognition of European CE Marking
- Establishing equivalence routes with other trusted agencies, such as the US FDA “for a greater portion of products”
Routes for Innovation
The Advisory Group agreed that the UK should support manufacturers of innovative and novel products, including building upon the Innovative Devices Access Pathway and the AI Airlock process.
Solutions in consideration include:
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- Proactive action to seek out innovative devices
- Customized pre-market regulatory advice for manufacturers of novel/innovative products
System Capacity
The Advisory Group recognizes the need to have sufficient regulatory expertise to support medtech through the regulatory process. This need is to be shared between the public and private sectors.
Solutions in consideration include:
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- Creating a UK regulatory skills program
- Investing in UK ‘Centers of Excellence in Regulatory Science and Innovation’ (CERSIs)
What’s Next?
The Advisory Group indicated speed is essential and is aiming to assess the proposals by the end of April 2023.
Casus will keep you apprised as further details are released.
