The Business of Eye Innovation - Episode 10

Facing Europe’s MDR Head-On

We’re talking all about the MDR (the European medical device regulations) with legal expert Erik Vollebregt of Axon Lawyers - including the impact for manufacturers of the most recent vote by the European Parliament to extend the MDR transition periods.

The MDR is not on hold, and it isn’t the extension that some manufacturers think.

Listen in to learn what’s really going on with the MDR.

Speakers:

• HOST: Kristine Morrill, Founder and President of Medevise Consulting

• GUEST: Erik Vollebregt, Partner at Axon Lawyers – an Amsterdam-based law firm focused on the legal and regulatory aspects of the life sciences sector

KEY TAKEAWAYS:

• The problem with the original MDR timeline. The MDR first entered into force on 26th May, 2017. At the time, everybody could see that the timeline would be a problem. The notified bodies didn’t have sufficient capacity to convert the existing certificates before the date of application, at the time 26th May 2020. So the response was to massively reissued certificates under the old directives, which was still possible at the time with an expiration date against the latest possible date in the grace period, 26th of May 2024. That created a massive pile of certificates that would all expire towards the end of the grace period.

• What’s happening with the recent MDR proposal and vote by the European Parliament?
  The proposal voted in on 16 Feb 2023 extends the transition periods for Medical Devices Regulation (MDR) - from 26 May 2024 to 31 December 2027 or 31 December 2028, depending on the risk class of the device.
  
  However it’s important to note that these deadlines are fixed around the following requirements which must be in place before 26 May 2024 (before the original end of the original grace period):

  • have a fully MDR-compliant quality system in place

  • have launched an application with a notified body for MDR conformity assessment for the device to which it relates.  

Basically, there is no change for manufacturers. The notified bodies then have as of 26, May 2024 to finish the conformity assessment - until 2027 or 2028.

The only thing the proposal does is give notified bodies more time. It doesn't give manufacturers more time.

• Are there a enough MDR-certified notified bodies?
  You cannot say there is not enough notified bodies. The only thing you can say is notified bodies are not scaling total capacity quickly enough to solve this whole bulge in the pipeline

• Is there a downside for innovation in Europe as a result of the MDR?
  Small and medium-sized enterprizes may be put on the back burner by notified bodies because it's not very profitable for them. This may encourage these companies to look elsewhere such as the US or Japan to launch their products.

• How much clinical data do manufacturers need under the MDR?
  This is a common misunderstanding. Manufacturers do need some clinical data. They don't need a lot of clinical data.

• Are we slowly moving towards a European medicine and devices agency? Listen in to see what our guest Erik Vollebregt envisions for future regulations in Europe.

Learn more about Erik Vollebregt and Axon Lawyers. Follow Medevise on LinkedIn.