Navigating the evolving EU medical device regulations: Insights for MedTech innovators

by Rita Hendricusdottir on 5 Dec 2024

Reading time: 2 minutes

The medical device industry is undergoing significant transformation, particularly in the EU, with the introduction of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). To shed light on these changes and their implications, I had the pleasure of speaking with Steve Lee, a seasoned regulatory expert who has played a pivotal role in shaping these regulations during their development. Steve has worn many hats throughout his career, including serving as the Director of Diagnostics and Digital Regulation at ABHI (the UK Trade Association), and as a Senior Policy Advisor at the Medicines and Healthcare products Regulatory Agency (MHRA). With a background in clinical and manufacturing fields, Steve has been deeply involved in the regulatory domain, particularly in shaping the IVD landscape as the Chair of the In Vitro Diagnostic (IVD) working group in Brussels. Having advised the UK negotiators during the transition from the old directives to the new MDR and IVDR, Steve has seen first-hand how these regulations evolved and now affect the market. Their extensive experience offers valuable insights for innovators trying to bring their products to market under this complex and demanding regime.

Key regulatory changes for medical devices and IVDs

The changes brought about by MDR and IVDR are substantial, particularly for in vitro diagnostic devices (IVDs), where classification has shifted dramatically. Steve explains that "around 80 to 90% of IVDs were self-declared. Now 80-90% require third-party scrutiny under the new regulations". This means that many devices, which previously bypassed the need for notified body approval will now be subject to more rigorous oversight. The new classification system, replacing the old list-based approach, introduces a rules-based system with categories A to D, with category D being the highest risk.

For MedTech innovators, especially those working with software, Steve highlights that the shift in classification now means that many software-based devices will be upgraded from self-declaration to class IIa or IIb, involving notified body approval. This increased scrutiny requires more robust clinical data and tighter rules around equivalence with existing devices. "The rules around equivalence have been tightened, meaning in practice you will probably need explicit permission from manufacturers if you are basing your clinical evidence on a competitor’s device".

Growing focus - Post-Market Surveillance

Post-market surveillance is another area that has seen increased regulatory attention. "It’s no longer enough to wait for problems to arise; manufacturers need to proactively gather evidence and continually monitor their devices," Steve notes. This is where unique device identification (UDI) becomes crucial for traceability and managing recalls or corrective actions. Innovators must now anticipate these requirements from the start, integrating post-market planning into their regulatory strategies.

Notified Bodies: A crucial partner

One of the most common challenges MedTech companies face is navigating the complexities of working with notified bodies. Steve explains that "Notified bodies get a lot of criticism, but they are simply following what they’re required to do". The rigid interpretation of the regulations by notified bodies, coupled with the limited availability of these organisations, creates bottlenecks in the market. "It’s especially tough for new, innovative products that have no legacy to fall back on, they must meet the new requirements right away."

Steve emphasises the importance of early engagement with notified bodies. “Understanding what they need and ensuring your documentation is complete and clear from the outset can save you a lot of time and frustration. A rejected submission due to incomplete data can be very costly.”

Strategies for MedTech innovators

For those navigating these regulatory waters, Steve offers crucial advice: have a clear regulatory strategy. "I’ve heard companies say their strategy is simply to gather clinical evidence and present it to the competent authority. That’s naive." Instead, Steve suggests understanding the intended purpose of your device, determining its classification early, and gathering the right clinical evidence based on those decisions.

Engaging with regulatory experts and clinical specialists from the start is also vital. Steve analogises to “think of it like modern car maintenance. In the 1980s, you could look under the bonnet and fix things yourself. But with today’s cars, you need a team of specialists, diagnostic tools, and computers to keep everything running smoothly. That’s how regulations have evolved, and you need the right support to navigate them."

Beyond the EU

While the focus may be on EU regulations, Steve advises innovators to consider their position in the global market. The CE mark, recognised in countries like Canada, the UK, and Australia, offers a valuable gateway for many markets. However, MedTech innovators should tailor their strategy to their target markets, whether it's focusing on the EU or expanding globally.

Final thoughts

For MedTech innovators, the road to regulatory approval is more complex than ever. Steve’s final piece of advice is clear: "It’s never too early to start planning your regulatory strategy" and there are great tools out there such as RegMetrics that can support you on this journey.

With the right approach, an understanding of the regulatory landscape, and early engagement with notified bodies, innovators can navigate the bottlenecks and bring their products to market more smoothly. As the regulatory landscape continues to evolve, keeping up to date with changes and engaging with experts will be key to success in the EU and beyond.