Description: The EU MDR brought some new and more stringent requirements to be fulfilled to demonstrate the safety and performance of a medical device and to show conformity with the GSPRs. We still see some changes in the interpretation of clinical data requirements with the publications of new MDCG guidance documents, e.g., the recently published MDCG 2024-10 on orphan medical devices. Besides clarification, these MDCG guidance documents also bring some challenges on how to implement them for ongoing clinical evaluation projects. In this session, two clinical evaluators from a Notified Body and a clinical consultant will dive into some relevant topics on the clinical evaluation requirements under the EU MDR. There will be short presentations on how to conduct a sufficient state-of-the-art analysis, the clinical data and strategy that could be used for medical devices in niche indications, and valuable insights on developing a successful PMCF strategy.
Learning Objectives:
Participants will learn directly from Notified Bodies and a consultant on the updates on clinical evidence
Participants will gain valuable information they can implement in their future clinical evaluations
Participants will be able to address specific questions with the experts in a Q&A session
