Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Co-development: Analytical performance aspects (1)

• According to the IVDR, analytical performance (and scientific validity) should be demonstrated prior to an IVD clinical performance study

Demonstrate analytical performance

This is aligned to (this) drug regulator viewpoint:

•

• biomarker assays should be analytically validated for their intended purpose in the trial • level of validation should be more stringent when assay used to manage trial subjects e.g. decide inclusion, allocate treatment

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Biomarker tests may be used for trial eligibility (targeted design) at early phases of drug development: • Prototype CDx or CDx that is CE marked for different intended purpose • Considered IVD or RUO? • What level of analytical validation is acceptable? • At what timepoint should analytical performance be demonstrated? • Could an early phase drug trial be considered an IVD clinical performance study? • What about adaptive study designs? Co-development: Analytical performance aspects (2) Demonstrate analytical performance?

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