– June 28th 2022

Clinical Evidence for IVDs: The New Good Study Pratice

Clinical performance studies should always be designed to specify the clinical evidence that the study is intended to produce taking into account potential risks, appropriate ethical requirements, and ensuring compliance with all applicable legal and regulatory requirements.

Through the Clinical Performance Study Plan (CPSP), the criteria, objectives, design, proposed analysis, methodology, monitoring conduct, and registration of the clinical performance study are defined (Annex XIII IVDR 2.3.2).

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