What is a performance study?

A clinical performance study is designed to investigate the ability of a device to provide results related to a specific clinical condition or physiological process in a specific group of people and intended users - in other words, a diagnostic device.

In order to assess this, certain parameters must be analysed in accordance with Regulation (EU) 2017/746 as part of the performance evaluation on in vitro diagnostic medical devices (IVDR):

• how well the product recognises diseases (diagnostic sensitivity),
• how accurately it determines that no disease is present (diagnostic specificity),
• the probability that the product correctly predicts that a disease is present (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).

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 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.

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