The AI Act isn’t an obstacle but a potential innovation catalyst for EU healthcare businesses, which they can leverage for global impact. Find out why and gain critical insights for a successful market launch.
Rising costs, an aging population, inequalities, and healthcare worker shortages make now an especially important moment for innovation.
However, the guardrails to ensure medical devices, pharmaceuticals, and the whole spectrum of healthcare products are safe and effective can create obstacles that make bringing new ideas to market difficult.
How do you navigate EU regulations? What areas should you focus on to make the process quicker and more efficient so your solutions can drive an impact faster?
This panel discussion is your roadmap. Understand the intricate EU regulatory landscape and the best approach for your organization from the point of view of a medical technology startup, a notified body, and a technology partner.
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The transition between the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) was a significant shift in regulatory requirements. It’s impacted every EU company as they must comply with stricter regulations, undergo more extensive clinical evaluations, and face increased scrutiny during certification.
Diego shared advice for how companies can work through more stringent rules and product reclassifications of the MDR.
As a pioneering MedTech startup, gMendel is on the front lines of EU regulation change. One of their larger challenges was more specific to the In Vitro Diagnostic Regulation (IVDR) and the varying requirements and growing complexities among international markets.
Zoran noted ‘a paradigm shift’ from a few years ago. Now, many companies prefer to launch in the US and UK first, which is interesting as the FDA was always seen as the tougher obstacle for new companies. It’s a unique moment, as Antonina also observed that many Star clients have similarly chosen to delay the EU market launch in favor of other locations.
On a broad scale, this could be a sign of slowing innovation in the EU until at least a clearer roadmap and strategies are put into place.
The conversation also focuses on strategies to streamline the regulatory journey. Diego explained that companies must realize that the longest part of the approval process is the documentation phase. This can be shortened by several months, however, if these obstacles are overcome:
What’s his top piece of advice? Companies need to consider the MDCG 2020-13 — the minimum template used by the notified body for clinical application and correct assessment of the requirements.
No conversation about regulations right now is complete without talking about The Artificial Intelligence Act. As Zoran emphasizes, what’s particularly important and demanding is that while the MDR took years to be debated and later enforced, the time horizon of the AI Act is very short.
Given the significance of AI in their product, gMendel prioritizes understanding the AI Act through extensive reviews with internal AI experts and external consultants, focusing primarily on defining high-risk AI and the safety component. He sees the EU needing to strike the right balance between regulation and innovation to ensure adequate oversight while avoiding stifling progress and falling behind in the rapidly evolving AI landscape.
Even with breakthrough new technology, gMendel has quickly moved into the market. What’s been their strategy?
Zoran has launched numerous regulated and unregulated healthcare products over his career. His advice focused on a few key areas:
There’s much more in our full panel discussion. We cover data protection, privacy regulations, and go deeper into AI. You’ll also hear additional insights from the moderator and Head of Quality and Regulatory Consulting at Star, Antonina Burlachenko, discover more strategies for streamlining the regulatory journey, and dive more into gMendel’s story, including why they chose to partner with Star.
Star’s Regulatory Consulting works within healthcare and across industries to help companies worldwide to make compliance simple and efficient so they can focus on their core business. Get in touch with us to learn how we can support you.
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Star is a global technology company that connects regulatory and product strategy, design and engineering services and helps companies to accelerate their product innovation. Our team of strategists, designers and engineers share an underlying passion for co-creating purposeful MedTech and digital healthcare products that bring value to people’s lives worldwide.
