SOUNDS OF SCIENCE - EPISODE 15

On today’s episode, we focus on the EU’s Medical Device Regulation (MDR) which came into full effect on 26 May 2021 and followed by the In Vitro Diagnostic Device Regulation (IVDR) the following year. The idea of both regulations is to balance the regulatory review and approval processes of medical devices and IVDs across all EU Member States, essentially harmonizing the European market for medical devices.

However, the Medical Device Regulation is causing some problems, and stakeholders and politicians at both the national and EU levels are warning that the MDR is leading to potential medical device shortages, and even medical devices disappearing from the EU market as a whole.

In short, the main problem is that under the MDR, all medical devices produced in Europe must be re-certified. Re-certification needs to be done by a notified body, which is a national organisation designated by an EU country to assess the conformity of devices placed on the market. The main reason for the shortages is the capacity of these notified bodies to recertify. There are currently only 36 notified bodies with 23,000 certificates that need to transfer very much at the same time. Also, most manufacturers are not prepared for the new and sometimes costly rules of the MDR.

In light of all this, and primarily to prevent the imminent risk of shortages, the European Commission decided to amend the medical device and in vitro diagnostic regulations. To help us breakdown the recent changes and what it means for EU medical device companies, we’re joined by three experts in the medical devices space:

• Jörg Plessl, Head of Global Regulatory Affairs, Norgine
• Megan Doyle, Director, Global Regulatory and R&D Policy, Amgen
• Axel Korth, Sr. Legal and Regulatory Affairs Advisor, EUCOPE

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If you're a medical device company looking to add your voice to the ongoing debate and need help navigating the complex EU medical device market, please reach out to EUCOPE's Leander Vranken ([email protected]) to learn how to join our MDR/IVDR Focus Group.