What is a performance study?

A clinical performance study is intended to investigate the ability of a device to provide results related to a specific clinical condition or physiological process in a specific group of humans and intended users. To assess this, certain parameters must be examined in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

- how well the product detects diseases (diagnostic sensitivity),

- how exactly it determines that no disease is present (diagnostic specificity),

- the probability that the product correctly predicts the presence of a disease (positive predictive value),

- the probability that it correctly predicts that no disease is present (negative predictive value),

- the ratio of probabilities (likelihood ratio) and

- expected values in groups of people with and without the disease to be tested (expected values in unaffected and affected population groups).

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Diagnostic procedures can either bear a CE mark or not, lead to a decision by doctors or leave them uninfluenced, take place within or outside the so-called intended purpose, or involve additional risks or burdens for study participants. The complexity of the study and whether or not authorities need to be involved will depend on these and other factors.