The requirements defined in ISO 20916:2019 and the EU’s In Vitro Diagnostic Regulation (IVDR) 2017/746 (effective May 26, 2022) have introduced several challenges for manufacturers to navigate in order to keep their devices on the market. While compliance to IVDR has been extended based on the risk of the device, many IVDs still require substantial clinical performance studies to be completed. Failure to execute these studies could lead to costly rework for the manufacturer and potentially relabeling or excess inventory.
Join NAMSA for this webinar as we walk through the key differences between EU’s In Vitro Diagnostic Directive (IVDD) and IVDR and the clinical study requirements outlined within these regulations. We will also examine ISO 20916:2019 as the Good Clinical Practice (GCP) guidance for IVD clinical performance.
Attendees of this webinar can expect to gain a better understanding of:
- Key regulations and applicability
- Intended use/indications for use/clinical performance
- IVDR options for clinical performance data, new requirements
- ISO 20916 as the guide to conducting clinical performance studies for IVD products
- IVD performance evaluation (high-level requirements)