The EU Medical Device Regulation (MDR) has reshaped the European regulatory landscape — bringing new rigor, new challenges, and plenty of confusion.
In this episode, Michelle Lott joins Etienne Nichols (Greenlight Guru) and Karandeep Singh Badwal to debate the real-world impact of MDR on medtech innovation, market access, and patient safety.
From notified body bottlenecks to language barriers, inconsistent interpretations, and the myth of increased safety, the trio unpacks what MDR is really doing to the industry — and what manufacturers can do to survive (and thrive) under it.
Here's what you’ll learn:
How MDR differs from MDD — and why it’s not a total overhaul
Why software, AI, and post-market surveillance have become regulatory pain points
The 12–18 month reality of CE marking under MDR
How to select the right notified body (and why language matters)
Why documentation ≠ device safety — and integrity still matters most
The “significant change” rule: what triggers recertification
Why smaller companies are struggling to stay in the EU market
Practical steps to build a quality culture and navigate MDR effectively
Subscribe to the leanRAQA Today podcast for even more bold, insightful conversations that make medtech regulation make sense.
Watch the video on YouTube: https://youtu.be/Kgbmh0neJpE
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