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ViewAttendees 25

Medical Devices

Domain: Product Development & Registration

Knowledge Area: General

Expert Advisory Panel - What Have we Learned?

Thursday, May 11, 2023
16:45 – 17:45 CEST
Location: Pearl 1

Supported By
Description: The EU Expert Panels were formed and operational from 1st April 2021. To date 4 opinions have been published, but there are many assessments that have been submitted by notified bodies. This session will enable attendees to return back to the workplace with the confidence on how to prepare CER submissions for new devices that could be subject to the CECP process to ensure they receive a positive opinion. They will have a better understanding of the aspects of novelty that the expert panels will focus on, and ensure they have sufficient data in preparation for the MDR submission of new devices.

Learning Objectives:

  • Understand the CECP Process and be able to prepare a good CER in relation to describing Novelty to ensure a smooth application process.
  • Understand the focus of the expert panels in their decision making based on previous released opinions and describe the expectations
  • demonstrate and describe an understanding of the CECP process and required steps needed to prepare an appropriate CER, PMCF Plan, and CDP.