Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

• Process of Performance Evaluation • Done according to a Performance Evaluation Plan • Collated as a Performance Evaluation Report • Sum total = Clinical Evidence

• Continuous during life-time of the device

Performance Evaluation for IVDs

The Organisation for Professionals in Regulatory Affairs

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– demonstrate the following in accordance with Intended Use Statement:

Scientific Validity

Analytical Performance

Clinical Performance

The association of an analyte to a clinical condition or a physiological state

The ability of a device to correctly detect or measure a particular analyte

The ability of a device to yield results that are correlated with a particular clinical condition or a pathological

process or state in accordance with the target population and intended user

Performance Indicators for IVDs

The Organisation for Professionals in Regulatory Affairs

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