Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

European Medicines Agency guidance

• EMA recognises that the new IVD regulation has implications for the co-development of personalised medicines and CDx • Concept paper published in 2017 - to be developed into a Guideline Recommendations on • interface between drugs and predictive biomarker-based assays including CDx • Guidance on the use of clinical drug trials to generate evidence to support validation of the CDx •

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CDx IVD clinical performance studies

• We all wish to avoid unnecessary interventional clinical studies • Pivotal drug study could also serve as CDx IVD clinical performance study if the design can address: 1. Does the CDx result predict who is likely to respond to the drug?

Stratified design

or 2. Does CDx IVD select a population for whom drug is safe and effective?

Targeted (enriched) design

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