What are Common Pitfalls in Clinical Evaluation and Performance Evaluation - An Analysis of the Feedback from Different Notified Bodies

Description: The EU MDR and the EU IVDR have been applicable for a few years now, and there are still questions and challenges regarding the clinical evidence for medical devices and in vitro diagnostics. Manufacturers and Notified Bodies have seen a significant increase in the volume of the required clinical evaluation documentation, like the CEP/PEP or the CER/PER, conditioned by the more stringent requirements for clinical data compared to the previous Directives. Due to the more stringent requirements and the complexity of the clinical evaluation, the documentation is susceptible to errors which could lead to questions by the assessing Notified Body and possibly delay the CE marking process.
In this session, there will be presentations from two Notified Bodies and a clinical consultant on commonly seen issues with clinical submission under the MDR and IVDR. This session will provide participants with insights and possible strategies to avoid these deficiencies for future submissions.
During the Q&A session, the participants will be able to ask their questions to the panelist.