Industry Voices: The Regulatory Maze of MedTech, Insights from Amanda Maxwell

Amanda Maxwell is EU MedTech Regulatory Affairs Editor at Medtech Insight, where she’s been reporting on EU regulations since their inception. As part of our “Industry Voices” series, she gives a front-row view of the shifting regulatory tides and the market changes that follow. 

We sat down with Amanda to explore the current state of EU and UK regulations, how they’re reorganising the MedTech industry, and where opportunities still exist for those ready to navigate the maze. 

"In the '90s, many medical devices weren’t regulated at all in the EU, now the system is so complex, it’s pushing innovation out.” 

From Common Framework to Complex Burden 

EU medical device regulation was originally designed to unify fragmented national systems and enable safe, cross-border trade. But with the arrival of the MDR and IVDR, the bar has been raised — particularly for higher-risk devices. 

As a result, compliance has become not only more complex, but also more expensive. Products are being withdrawn, not due to safety concerns, but because keeping them on the market simply isn’t worth the cost or red tape. 

“Innovation is slowing. Some companies are going straight to the US instead.” 

Brexit: Divergence in Motion 

(This section includes contributions from Ashley Yeo) 

Since Brexit, Great Britain has stuck with the older EU directives, while Northern Ireland follows the newer MDR/IVDR — effectively creating two systems within one nation.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is now modernising regulations through reforms like the 2025 Post-Market Surveillance SI, which mandates faster incident reporting and stricter oversight. There’s also a push toward more proportionate regulation for IVDs and AI-based devices — including proposals for international device recognition (e.g. US, Canada, Australia). 

“We’re seeing more flexibility in the UK — but also more complexity for manufacturers operating in both regions.” 

And for EU manufacturers? There’s a silver lining: the UK is consulting on keeping CE-marked devices on the GB market indefinitely beyond 2030. 

When AI Meets MDR: A Misfit? 

AI and digital health are advancing rapidly, but the regulatory systems weren’t built for them. MDR still applies traditional frameworks to AI-based devices, often without the nuance needed for software-driven innovation. 

“Right now, the EU treats an AI-powered device like a toaster with code.” 

The regulatory web is particularly challenging for startups. Between GDPR, the AI Act, the Cyber Resilience Act, and the MDR/IVDR themselves, the costs and time required can overwhelm smaller players. 

“There’s opportunity — but only for companies with the funding, expertise, and strategy to survive the complexity.” 

Global (Dis)Alignment 

The International Medical Device Regulators Forum (IMDRF) has made real progress in harmonising global standards. But politics are getting in the way. 

“We’ve gone from the FDA being stricter than the EU to the opposite — and with current political shifts, further divergence seems likely.” 

If the US continues on a path of deregulation, it could attract more MedTech players away from the EU. Yet there’s still a reputational edge to EU-certified devices — at least for now. 

What’s Holding EU MedTech Back? 

According to Amanda, there are three critical, interconnected challenges: 

1. Regulatory Overload: too many overlapping rules (AI, environment, digital health) and too much documentation, especially for smaller companies.  
2. The US/EU Divide: the US is leaning into simplicity, while the EU tightens the net. This imbalance may shift global strategies, depending on who’s in power. 
3. The Call for Reform: there’s growing pressure within the EU to simplify its regulatory landscape, but any change will take time and may create more short-term disruption. 

A Consultant’s View from the Inside 

Amanda’s work as a regulatory consultant gave her a deeper understanding of how companies (from startups to multinationals) experience the regulatory burden. 

“Even large companies struggle to stay up to date. Most end up bringing in consultants because the landscape is just too fast-moving and complex.” 

And it’s not just about staying compliant, it’s about building internal understanding, aligning strategy, and making smart, forward-looking decisions. 

Read more industry insights on our Medical Devices page. 

Special thanks to Ashley Yeo for his contributions to the Brexit and UK regulation section of this article.