Demonstration of the clinical performance of your IVD

The clinical performance describes the usability of the specific device in a clinical context. Together with the analytical performance and the scientific validity, it goes into performance evaluation: based on performance data, both the requirements relevant to performance and the assessment of risks and the acceptance of the benefit/risk ratio are demonstrated.

According to IVDR Annex XIII, demonstration of the clinical performance of a device is based on one or a combination of the following sources:
  • clinical performance studies;
  • scientific peer-reviewed literature;
  • published experience gained by routine diagnostic testing.
  • Clinical performance studies must be performed unless due justification is provided for relying on other sources of clinical performance data.
  • Clinical performance is demonstrated and documented in the clinical performance report.

Clinical trials are to demonstrate or confirm the performance aspects of a device that cannot be demonstrated based on analytical or clinical performance studies, literature and/or experience gained from diagnostic routine tests.

We are happy to support you in all questions of validation and verification of your IVD.

Definition clinical performance

Ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user.Contact us

Parameters for demonstrating a device’s clinical performance

Based on performance evaluation studies, the manufacturer demonstrates the clinical performance of the device considering all the parameters according to Annex I Section 9.1b. These include among others:
  • diagnostic sensitivity,
  • diagnostic specificity,
  • positive and negative predictive value,
  • likelihood ratio or
  • expected values in normal and affected populations.
All the parameters described must be considered unless any omission can be justified as not applicable.

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