Skip to main content
RAPS Euro Convergence 2025 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Networking Event
Networking Event
Sponsor Presentation
Sponsor Presentation
Ticketed Event
Ticketed Event
Evaluation

Medical Devices

Bringing Innovative Medical Devices to the EU Market

Thursday, May 15, 2025
16:45 - 17:45 CEST
Location: Silver Hall (level 0)
Learning Level: Intermediate
Description: Bringing innovative devices to the market under MDR can be challenging. To the general complexity of the regulatory landscape manufacturers have to add the challenges of navigating through unexplored territories, often without the help of standards, guidance documents or previous clinical experience. In the EU there is no formal path for approval of “breakthrough devices”, unlike the US, however some tools and processes are available to make the certification process more predictable.

This session will start from a manufacturer’s direct experience and will then discuss the possible support that can be obtained from Notified Bodies by means of the “structured dialogue” process and by EMA through the expert panel’s scientific advice.

Learning Objectives:

  • Understand the regulatory framework and the challenges of bringing innovative medical devices to the market in EU
  • Understand process, benefits and limitations of the Notified Body’s “structured dialogue” process
  • Understanding process, benefits and limitations of the EMA’s scientific advice process (expert panel)