2023 - Navigating IVDR: Challenges and Strategies for Clinical Trial Assay Development and Regulatory Submissions

Over the past year, in vitro diagnostic regulation (IVDR) has emerged as a pivotal regulatory framework for ensuring the safety, performance and reliability of medical devices, but navigating the IVDR landscape has been met with challenges. With the implementation of IVDR, it is crucial for clinical trial sponsors and CROs to understand the complexities and nuances of this regulation to successfully navigate the path from assay development to regulatory submission and approval.
This webinar aims to provide a comprehensive overview of IVDR and explore the challenges encountered during the submission and approval process for clinical trial assays, including examples of feedback received from Member States and how to address them. It will discuss the delegation of responsibilities to CROs by clinical trial sponsors, as well as emphasize the criticality of performance study documentation to help the clinical trial assay along the path to regulatory submission and approval. Additionally, participants will gain insights into the classification of medical devices based on the rules outlined in Annex VIII of the IVDR.
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Finally, the webinar will provide a brief explanation of the classification of medical devices based on the rules outlined in Annex VIII of the IVDR to provide a better understanding of the classification criteria and the impact on the regulatory pathway the device must follow.
Register for this webinar to gain a comprehensive overview of IVDR and its implications for clinical trial assay submissions. Learn how to navigate challenges, address feedback, and ensure compliance with the regulation.