Sounds of Science Podcast – Episode 15 on EU’s Medical Device Regulation (MDR) & In Vitro Diagnostics Regulation (IVDR)

Apr 14, 2023

Implications on medical device companies and patients

Posted by European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

The Medical Devices Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR) have now both been amended to ensure that all devices used across the EU meet higher quality and safety standards through a more rigorous assessment by notified bodies.

🎙️Jörg Plessl, Head of Global Regulatory Affairs, Norgine, Megan Doyle, Director, Global Regulatory and R&D Policy, Amgen and EUCOPE’s Sr. Legal and Regulatory Affairs Advisor Dr. Axel Korth join our latest podcast to review these recent changes and discusses what they mean for medical devices, biotech companies and patients.

🗣️This episode is hosted by EUCOPE’s Leander Vranken

Full episode here: 

ℹ️If you’re a medtech company looking to amplify your voice and need help navigating the complex EU medical device market, please reach out to EUCOPE’s Leander Vranken ( to learn how to join our MDR/IVDR Focus Group.

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