EUCOPE Resources / News - April 11, 2023

🎙️Sounds of Science Podcast #15 on MDR/IVDR Amendments

Sounds of Science Podcast – Episode 15

MDR/IVDR: Recent changes and their implications for EU medical device companies and patients

The EU’s Medical Device Regulation (MDR) came into full effect on 26 May 2021 and was 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 several problems, and stakeholders and politicians at both the national and EU level 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 biotech and 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 & Regulatory Affairs Advisor, EUCOPE

This episode is hosted by EUCOPE’s Policy Officer Leander Vranken.

You can listen to Episode 15 and all other Sounds of Science podcast episodes using the links below:

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Episode Highlights

Notified bodies should develop schemes to allocate capacity for SMEs and manufacturers that are first time participants in this conformity assessment procedures to ensure that they can get their product certified.”

“The legislator, the Commission, the Council and the Parliament acted together and passed this piece of legislation, which I think, is quite pragmatic and, hopefully addresses the major issues.”

The data show that IVDR, and MDR, are both negatively impacting access to clinical research in Europe and may lead sponsors to conduct studies elsewhere.”

We hope the authorities will consider the impact that implementation of these regulations is having on clinical research in Europe and take swift action to adopt these proposalsThat is critically needed to keep clinical trials in Europe.

It took the European Commission, Parliament, and Council only 8 weeks to come to a solution in a so-called “accelerated co-decision” procedure which shows that the EU is willing to act if necessary and imminent.”

“The proposal removes the sell-off dates allowing safe medical devices and in vitro devices that are already on the market to remain on the market which prevents unnecessary disposal, further shortages, and prevents contributing to the risk of another public health crisis that could materialize.”

 


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 to learn how to join our MDR/IVDR Focus Group.

If your company would like to put forward a topic for us to discuss or to participate in a future podcast episode, please reach out to our producer, Dante Di Iulio.