Medical devices range from simple fillings to highly sophisticated robotics, with more than half a million available in the EU alone. However, regulations differ widely across regions and countries. What does this mean for medical device development around the world?
In this episode of Balancing the Future, Micah and Chai interview Dr. Dominik Lysek, Executive Board Member and CEO of PharmaTrail, a software company that helps pharmaceutical, biotech, and medtech companies manage clinical trial data with blockchain technology. Dominik has worked with medical devices throughout his career and has closely followed both the EU and US markets.
Dominik explains how the EU and the US each regulate their medical device markets. One key difference is that the US provides clear timelines for approvals, while Europe does not set specific deadlines. In the EU, even a modified version of an already approved and safe product still needs to go through regulatory approval. However, new Medical Device Regulation 2.0 legislation now being considered by the EU parliament could change this by introducing clear deadlines and reducing bureaucracy.
Even with these possible changes, both the EU and US still require strong and reliable data to approve new products. MDR 2.0 will allow different types of clinical data, like in vitro and model data, to be included in applications. Dominik emphasizes that a rigorous process is important so patients can trust and benefit from the medical devices they use. He believes the industry should always put patients first.
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