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Evaluation

Medical Devices

Clinical Data Challenges for Novel and Legacy Medical Devices - Panel Discussion with Clinical Experts from Multiple Notified Bodies

Wednesday, May 14, 2025
14:30 - 15:30 CEST
Location: Gold Hall (level 0)
Learning Level: Advanced
Description: The European Union's transition from the Medical Device Directives (MDD and AIMDD) to the Medical Device Regulation (EU MDR) is ongoing. Despite new or updated ISO standards and guidance documents, the challenges of providing sufficient clinical data for novel and legacy devices persist.

With the deadline approaching, many manufacturers prioritize transitioning their legacy devices and meeting the stricter clinical data requirements, potentially delaying the launch of novel devices in the EU. Start-ups and SMEs face specific hurdles due to Europe's perceived stringent clinical data expectations, raising concerns that European patients may experience delays in having access to innovative devices compared to other regions.

This panel discussion, featuring clinical experts from three leading notified bodies, will explore current interpretations of clinical data requirements and the latest published standards and guidance documents. The Q&A session will allow the audience to engage directly with notified body representatives, discuss these critical issues, and have their specific questions answered.

Learning Objectives:

  • Understand the latest updates in the interpretation and evaluation of clinical data for medical devices under the EU MDR.
  • address their specific questions and directly engage with clinical experts from multiple notified bodies.
  • Define the required level of quantity and quality of clinical data necessary for a successful EU MDR submission.