First Time Right – Best Practices for Generation of High-quality Data in IVDR Performance Studies

Description: The requirements for clinical evidence have increased significantly under the EU IVD regulation (IVDR, Regulation (EU) 2017/746). Manufacturers must demonstrate scientific validity, analytical performance and clinical performance unless they can justify that some of these elements are not applicable due to the specific nature of their device.

For many legacy devices, manufacturers may be able to rely on existing data in combination with literature reviews, but need to demonstrate that the legacy data complies with the IVDR and was generated under Good Clinical Study Practice (GCP). For most new devices, GCP-compliant clinical performance studies are required with study designs ranging from testing leftover samples from routine clinical testing or sourced from biobanks, prospective studies for sample collection to interventional studies where the test result is used for patient management decisions.

This session will discuss strategies for ensuring the integrity and quality of clinical data for both existing and new IVD devices. In addition, best practices for generating IVDR-compliant documentation of performance evaluation will be shared from the perspective of manufacturers and notified body reviewers. The speakers will also highlight the links between the different elements of IVDR clinical evidence and the use of post-market performance follow-up activities to supplement premarket clinical data.