Demonstration of the analytical performance of your IVD

Performance evaluation has the same objective as clinical investigation of any other medical device: Based on performance data, both the requirements relevant to performance and the assessment of risks and the acceptance of the benefit/risk ratio must be demonstrated. These performance data include information on the analytical performance and clinical performance of the device.

The analytical performance demonstrates the ability of your device to correctly detect or measure a particular analyte.

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Verification demonstrates that your product was developed and built correctly and is thus an essential part of the development of any IVD medical device.

Parameters for demonstrating a device’s analytical performance[

According to IVDR Annex I Section 9.1a, the determination of the following parameters is considered analytical performance:
  • analytical sensitivity,
  • analytical specificity,
  • trueness (bias),
  • precision (repeatability and reproducibility),
  • accuracy (resulting from trueness and precision),
  • limits of detection and quantitation,
  • measuring range,
  • linearity,
  • cut-off, including determination of appropriate criteria for specimen collection and handling and control of known relevant endogenous and exogenous interference,
  • cross-reactions

All the parameters described must be considered unless any omission can be justified as not applicable.

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