LTR 83: Road to market for AI devices in the EU just got more complex
Let's Talk Risk! with Dr. Naveen Agarwal · Casual and informal conversations about practical aspects of medical device risk management.
January 15, 20251m 7s
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Show Notes
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Summary
“Manufacturers that want to go to the European market, thinking about AI devices, it’s really important that you don’t look only at the MDR. You really have to look at the AI Act as well.”
In this episode of the Let's Talk Risk Podcast, Florian Tolkmitt discusses the rapidly evolving regulatory landscape for medical devices in Europe, particularl…