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Medical Devices

The Paradigm Shift in the EU Market Approval of Devices and IVDs – a Hot Potato?!

Wednesday, May 8, 2024
10:25 – 11:25 CEST
Location: C 01
Learning Level: Expert

Description: Implementation on the EU MDR (and IVDR) is at the verge of breakdown. Years of extension have been granted to fix the claimed notified body capacity issues. But as time progresses, we see that we might have to go back to the root cause. Is capacity really the issue? Notified bodies are openly looking for more work, as submissions are not coming in at the pace needed to make effective use of the time extension.

And meanwhile lots of guidance documents are being produced, but their focus largely is on getting the systems the work rather than on the crux of the matter: what is sufficient, what is the new bar that is raised. No product specific guidance is produced, except perhaps the stent document, as that topic has been prioritized by EMA. Voices are expressing views on pros and cons of continuing the current system, or move into a more centralized system on the market approval, leading to more predictable timelines, attention to SMEs, support for orphan products, get back on stimulating innovation, and more agile production of product dossier relevant guidance. Others advocate keeping the implementation on track, as shifting focus will only cause more delays, potentially at the risk of patient care.

This panel will bring various stakeholders from industry, notified bodies and authorities to exchange views on the best path forward, keeping the patient support as the common goal. A session of 60 min will be a guided panel debate; a 90 min slot will allow for a serious Q&A interaction with the audience. Could be MDR track only, or if fitting the schedule it could cross over to include the IVD track. Two moderators will work together to coordinate the panel and audience in a smooth and rapid manner. Hope you all will join us!

Learning Objectives:

  • better understand the pros and cons of a more centralized system for EU market access on devices (and IVDs)
  • grasp the complexity of discussing systematic changes during current implementation
  • effectively understand their current actions aside from the regulatory overview discussions going on behind the scenes