The performance evaluation report evaluates and analyses data to meet the intended purpose of the IVD specified by the manufacturer. The IVDR also provides clinical performance studies to establish or confirm the performance aspects of an in vitro diagnostic medical device if these cannot be adequately documented by analytical performance studies or scientific literature. Performance Evaluation consists of Plan and report. Details are summarized below.
Performance Evaluation Report – An overview
Performance Evaluation Plan
- The intended purpose of the device.
- Specification of the characteristics of the product
- Specification of the analyte or marker that the product should determine.
- Details of the indications, contraindications, target patient groups of the IVD.
- Metrological traceability by use of reference materials and measuring methods of the IVD.
- Indication of the General safety and performance requirements supported by scientific data.
- Statistical methods are used to evaluate and analyze clinical performance, limitations, and information provided for IVD by the Manufacturer.
- Reference to current standards and guidelines.
- Provide risk-benefit ratio about the current state of medical research and clinical performance and its analysis.
- For devices classified as software, indication and specification of reference databases or articles published are a basis for decision-making.
- The life cycle of product development of in vitro diagnostic medical devices, demonstrating the validity and clinical performance.
- Detail on post-market performance follow-up (PMPF), defined in Part B of Annex XIII of the IVDR
Performance Evaluation Report
This report shall include at least the following points:
- Details of Methods used for the evaluation of the clinical evidence.
- Purpose and classification of the IVD, along with justification required for safety and performance characteristics.
- Information on the systematic search, selection, evaluation, analysis, and conclusions of the scientific literature on the in vitro diagnostic medical device under evaluation by means of protocol and report, including verification of the validity and evidence of the publications used.
- Results for the post-market performance follow-up as defined in Part B of Annex XIII of the IVDR.
- Classification of the latest scientific findings of the required performance parameters of the in vitro diagnostic medical device.
How to conduct Performance evaluation report docuemntation
Steps involved in conducting Performance Evaluation.
- Scientific validity
Involves measuring the same analyte or marker; in simple words, IVD is the analyte used to identify a physiological state or disease. If required, this can be achieved by literature search and evidence of pre-clinical studies or clinical performance. Reference: Annex XIII, Part A.
- Analytical performance
Involves measuring the performance characteristics of IVD. These include sensitivity, analytical specificity, trueness (bias), precision (repeatability and reproducibility), accuracy (resulting from trueness and precision), limits of detection and quantitation, measuring range, and linearity. Will summarize the outcome of the analytical performance evaluation in the Analytical performance report.
- Clinical performance:
Involves measuring the diagnostic accuracy of your device. These include diagnostic sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio, and expected values in normal and affected populations.
The performance evaluation provides clinical evidence, i.e. verification that a device is safe and accomplishes the desired clinical benefit. Clinical performance, analytical performance, and scientific validity are all evaluated in this performance review. Do you need support with documentation, procedures, related templates, and organizing the files suitable for Notified Body submission? Contact us today.