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Re: Question on 510(k) framework first?
A good answer from Tom and I would also like to add, it’s really important to understand the market economics in the territory and how you will get paid. Ask, will your product sell, in what volumes and what will your supply chain look like? Also a few other watch-outs like US require your clinical data to be generated using US patients, unless otherwise justified. So just make sure all aspects of your data package is also fit for the territory.
There are some really thoughtful questions coming in. Of course, with topics like these, there’s always an element of ‘it depends,’ but we’ll do our best to capture both the intent and the unknowns in your questions. Please keep them coming, and if we don’t get to everything today, we can always follow up afterwards.
Q: We’ve also heard from some members, that since Brexit, getting timely or consistent regulatory advice across markets has become even harder. From Sotas’ perspective, what’s the smartest way for companies to navigate these differing UK and EU requirements – especially for those operating in both regions?
Since Brexit, navigating the UK and EU regulatory systems have seemed more complex, but the situation is steadily improving. The UK Government’s intention to indefinitely recognise CE marking is a positive and practical move that provides stability and time for manufacturers to plan compliance strategies across both markets without unnecessary duplication.
The most effective approach is to build alignment wherever possible. Many foundational elements, such as quality management, clinical evidence, and risk management, are consistent between the two systems. Wherever possible, maintaining a single, comprehensive set of technical documentation that can be adapted for both CE and UKCA marks allows teams to work efficiently while maintaining rigour.
That said, companies must stay alert to the subtle but important procedural differences that have begun to emerge. For example, the UK has implemented new post market surveillance and vigilance requirements that demand more proactive monitoring, trending, and reporting of adverse events. Systems should be designed to capture, assess, and act on post market data across all territories, ensuring that your compliance framework meets the highest applicable standards.
It is also important to plan for the future direction of UK regulation. The upcoming UK MDR is expected to closely mirror the EU MDR in both structure and intent, so aligning your systems now will save significant rework later.
Finally, staying well informed is essential. Subscribing to updates from the MHRA, the European Commission, and industry bodies will help you stay ahead of changes and that information is free. Keep an eye on potential EU regulatory easements (expected) and Commission announcements, which can bring flexibility, transitional provisions, or extended deadlines that directly benefit manufacturers operating in both regions.
With strong documentation, harmonised systems, and continuous awareness of regulatory developments, companies can remain compliant and confident, while continuing to deliver innovation safely and effectively in both the UK and EU markets.