Speakers: Christa Cobbaert (the Netherlands); Alison Smith (United Kingdom); Phil Monaghan (United Kingdom)
Medical tests have a specific test purpose and role in clinical care pathways, deliver actionable results and possess analytical and clinical performance characteristics that guarantee a favorable benefit/harm ratio for patient management and/or outcome. Since 26 May 2022, the IVDR 2017/746 is in place which regulates EU market access of commercial tests to guarantee safety and effectiveness of tests for patients. The IVDR demands risk-based classification of tests, conformity assessment of clinical evidence requirements by third parties and post-market follow-up/surveillance during the lifecycle of a test.
During the webinar strengths and limitations of conventional LDL-c tests as primary target for Cardiovascular Risk Management (CVRM) will be discussed, especially against the background of evolution in clinical guidelines for CVRM. New clinical guidelines should trigger IVD-manufacturers and laboratory professionals to periodically reevaluate the fitness-for-clinical-purpose of existing tests as compared to emerging tests, and to reconsider the interdependence of analytical and clinical performance specifications.
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