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Regulation consistently ranks as one of the biggest barriers to innovation. In our Voice of Industry survey, members told us their top challenges include:
1️⃣ Navigating the complexity of the regulatory landscape
2️⃣ High costs of processes
3️⃣ Understanding evolving regulations
4️⃣ Brexit-related import issues
5️⃣ Lack of access to adviceThat’s why we’re piloting a brand-new live text-based forum for Medilink Midlands members!
👉 Join the trial and let’s open the conversation, share insights and address your regulatory challenges.
Inviting members to join in the online discussion surrounding the regulatory landscape, with Sotas. Global regulatory experts, on hand to respond to your questions.
Open for questions.
Live text based chat from 11am on Wednesday 15 October.
Many Medilink members tell us their biggest challenge is simply navigating the complexity of evolving regulations, especially when guidance feels open to interpretation.
From your experience at Sotas, what practical steps can smaller medtech or life sciences companies take to stay compliant without stalling innovation or burning through limited resources?
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?
Welcome to Sotas and any members joining us this morning to put their questions to today’s ‘Ask the Experts’ David and Matt.
Many Medilink members tell us their biggest challenge is simply navigating the complexity of evolving regulations, especially when guidance feels open to interpretation.
From your experience at Sotas, what practical steps can smaller medtech or life sciences companies take to stay compliant without stalling innovation or burning through limited resources?
You’re right that navigating evolving compliance requirements can be difficult, particularly for smaller organisations without dedicated compliance teams. From our experience at Sotas, the most effective approach is to make compliance a strategic enabler rather than a constraint.
Start with proportionality.
Begin with a lean Quality Management System aligned to ISO 13485 and expand it as your development and regulatory activities grow. Keep the system simple, structured, and reflective of how your team actually works day to day. When compliance becomes part of normal activity rather than a separate process, it supports innovation instead of slowing it down.Develop a clear regulatory strategy early.
This is often the most important step. A well-defined regulatory strategy helps align regulatory planning with business direction, clarifying target markets, clinical evidence requirements, and the pathway to approval. It ensures that innovation, funding, and compliance all move in the same direction.Anchor decisions in documented rationale.
Regulators look for traceability and logic. When your key choices are risk-based and well justified, you demonstrate control and understanding, even where guidance is open to interpretation.Use standards and selective expertise to accelerate progress.
Standards provide ready-made frameworks, and focused external input at key points can save time and uncertainty.Compliance should be seen as a tool that helps innovative ideas reach patients safely and sustainably.
Morning all. If you want international regulatory clearance for a new product, is it still best to follow the 510(k) framework first? About 15 years ago we were advised that it was the most prescriptive route and would cover most requirements for Europe, Australia, Canada, and others. Is that still true, or is there now a better approach to avoid repeating work when expanding to new markets?
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.
In my experience working with early-stage medtech companies, I often see uncertainty around whether a device should be classified as Class I or Class IIa under the MDR. Many teams aim for a Class I designation to minimise cost and regulatory burden but ultimately find themselves slipping into Class IIa territory. From your perspective as a regulatory expert, what are the key indicators that clearly distinguish Class I from Class IIa classification, and what are the most common pitfalls companies make when trying to justify a lower classification?
And a follow up – A similar challenge I see in the sector is around distinguishing wellbeing products from regulated medical devices. Many companies aim to position themselves in the wellbeing space to avoid the regulatory burden, but their marketing or functional claims can easily push them into “medical” territory. From your experience, where does the real line lie between wellbeing and medical under the MDR, and what kinds of claims or design features most often cause companies to inadvertently cross that line?
Q: Morning all. If you want international regulatory clearance for a new product, is it still best to follow the 510(k) framework first? About 15 years ago we were advised that it was the most prescriptive route and would cover most requirements for Europe, Australia, Canada, and others. Is that still true, or is there now a better approach to avoid repeating work when expanding to new markets?
That’s a really good question, and one we hear quite often. The US 510(k) route was once seen as a useful reference point for companies aiming for global market access, but the regulatory environment has evolved considerably.
The US 510(k) process focuses on showing that a new device is substantially equivalent to one already on the market, which makes it a structured and relatively predictable pathway for clearance within the US. However, this focus on equivalence does not fully align with the direction other regulators have taken. The EU and UK now place greater emphasis on demonstrating independent clinical evidence, maintaining ongoing post-market surveillance, and managing risk throughout the device lifecycle. There remains significant overlap in principles such as design control, risk management, and quality assurance, but the 510(k) approach alone no longer captures all expectations for international clearance. Other key markets, such as Australia and Canada, share many of these underlying principles. Australia is more closely aligned with the EU system, while Canada maintains its own conformity assessment framework.
The most effective approach today is to establish a clear regulatory strategy at the outset. A well-considered strategy looks across multiple jurisdictions, identifies where requirements align, and plans evidence generation and documentation so that each new market builds on the last. This helps avoid unnecessary repetition and supports efficient, compliant international expansion.
Thanks for questions so far! The Sotas team are working behind the scenes to craft their responses and will be back to you shortly.
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.
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.
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