The clinical evidence supports the intended purpose of the device as stated by you as the manufacturer and is based on a continuous process of performance evaluation, following a performance evaluation plan (PEP).
As the manufacturer of an IVD you assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of your device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that scientific validity, analytical and clinical performance data will allow you to make a final qualified assessment in the performance evaluation report (PER) whether the device will achieve the intended clinical benefit and safety, when used according to your instructions. The data and conclusions drawn from this assessment constitute the clinical evidence for the device.
As the manufacturer of an IVD you assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of your device with the general safety and performance requirements as referred to in Annex I. The amount and quality of that scientific validity, analytical and clinical performance data will allow you to make a final qualified assessment in the performance evaluation report (PER) whether the device will achieve the intended clinical benefit and safety, when used according to your instructions. The data and conclusions drawn from this assessment constitute the clinical evidence for the device.
To the point
With the performance evaluation you as the manufacturer demonstrate by appropriate means that the IVD placed on the market fulfills the general safety and performance requirements of the IVDR. Performance evaluation provides the clinical evidence that the IVD fulfills the performance characteristics specified in its intended use.
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Our contribution to your performance evaluation
We advise and support you efficiently in planning and implementing the performance evaluation, e.g. by:
- Developing and assessing the performance evaluation plan (PEP),
- Providing clinical evidence for the IVD based on literature (scientific validity, clinical performance),
- Developing and assessing the performance evaluation report (PER).
The three major components of your performance evaluation
1. Scientific validity
Scientific validity means the association of an analyte with a clinical condition or a physiological state.
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Scientific validity means the association of an analyte with a clinical condition or a physiological state.
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2. Analytical performanceThe analytical performance of a device describes its ability to correctly detect or measure a particular analyte.
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3. Clinical performanceThe 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.
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