IVD study types

Studies are essential components of all IVD life cycle phases. Additionally for constitution of the clinical evidence. They are conducted during product design, development, validation and performance assessment as well as during post-market activities.

• Exploratory, feasibility, analytical performance and clinical performance studies are conducted prior to IVD market launch. These studies are performed to assess how well an IVD can reliably measure the analyte of interest under controlled conditions (analytical performance) or in real-world clinical settings using patient samples (clinical performance)
• PMPF (Post-market performance follow-up) studies are part of the post-market surveillance system after the respective device is placed or made available on the market or put into service.
• For some specific IVD products (e.g. for self-tests) usability studies are required additionally.
• Furthermore, sample collection studies to assess specific samples or to build a human sample biobank can also support IVD development.

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