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Navigating Europe's MedTech Shift: A Guide to EU MDR Compliance
This episode provides a dense overview of the EU Medical Device Regulation (MDR 2017/745), a pivotal shift in European MedTech compliance. We explore the regulation's core pillars, from its emphasis on a total product lifecycle approach and stricter clinical data requirements to the challenges of device reclassification, the Notified Body bottleneck, and new transparency measures like EUDAMED and the UDI system. It’s a crucial guide for any manufacturer navigating this complex landscape. • What is the primary goal of Regulation (EU) 2017/745, the EU MDR? • How does the MDR shift focus from…
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