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.

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.