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The Performance Evaluation and clinical trials in IVD products are key to demonstrating compliance with the requirements of Annex I of the IVDR.
This confirmation of product compliance with the general safety and performance requirements (Annex I) of the IVDR must be based on data regarding the scientific validity and analytical and clinical performance of the product. This data must provide sufficient clinical evidence to demonstrate compliance with the general safety and performance requirements set out in Annex I that apply to the product.
The manufacturer itself will justify the level of clinical evidence necessary to demonstrate product compliance with applicable requirements. The level of evidence must be based on the characteristics of the product and its intended purpose and will support the intended purpose declared by the manufacturer.
The performance evaluation, therefore, must demonstrate the scientific validity, analytical performance, and clinical performance of the product. The data and conclusions drawn from these elements will constitute the product’s clinical evidence.
The performance evaluation of a product is a continuous process, and to plan, carry out continuously, and document it, the manufacturer must establish and update a performance evaluation plan (PEP). This plan must specify the characteristics and performance of the product and the process and criteria applied to generate the necessary clinical evidence.
This evaluation of scientific, analytical, and clinical validity can come from different sources, used alone or in combination. Let’s now determine what those sources might be.
Demonstration of Scientific Validity
The Demonstration of Scientific Validity is part of the Performance Evaluation. This will be carried out by the manufacturer based on one or more of the following sources or a combination of them:
Relevant information on the scientific validity of products that measure the same analyte or marker Peer-reviewed scientific literature Opinions or consensus positions of experts from relevant professional associations Results from proof-of-concept studies Results from performance studies
The results will be documented in the scientific validity report (part of the Performance Evaluation Report PER).
{{SHORTCODE_0}} Demonstration of scientific validity{{SHORTCODE_1}}
Demonstration of Analytical Performance
The Demonstration of Analytical Performance is part of the Performance Evaluation. It must be carried out based on: (unless its omission is justifiable for not being applicable)
Analytical sensitivity and specificity Trueness (bias) Precision (repeatability and reproducibility) Accuracy (resulting from trueness and precision) Limits of detection and quantification Measuring range Linearity Cut-off value including the determination of appropriate criteria for sample collection and handling and control of relevant known endogenous and exogenous interferences and cross-reactions.
As a general rule, the demonstration of analytical performance will be carried out through analytical performance studies and their results will be documented in the analytical performance report (part of the Performance Evaluation Report PER).
{{SHORTCODE_2}} Demonstration of analytical performance{{SHORTCODE_1}}
Demonstration of Clinical Performance
The Demonstration of Clinical Performance is part of the Performance Evaluation. It must be carried out based on: (unless its omission is justifiable for not being applicable)
Diagnostic sensitivity and specificity Positive and negative predictive value Likelihood ratio Expected values in healthy and diseased populations
The demonstration of clinical performance will be based on one or more of the following sources:
Clinical performance studies Peer-reviewed scientific literature Published experience gained with routine diagnostic tests It will be mandatory to conduct clinical performance studies unless due justification is provided to rely on other sources of clinical performance data.
The results will be documented in the clinical performance report (part of the Performance Evaluation Report PER).
{{SHORTCODE_4}} Demonstration of clinical performance{{SHORTCODE_1}}
Performance Studies
As seen, the main and most common source for demonstrating performance evaluation is the Performance Study.
A performance study is defined as the study to establish or confirm the analytical or clinical performance of the product.
It is important to highlight that there are certain performance studies that, due to their characteristics, require authorization from the competent authority.
Specifically, the performance studies that require such authorization are the following:
Those involving a surgically invasive sample collection solely for the study. Constituting an interventional clinical performance study (an interventional clinical performance study is defined as one whose results may influence patient care decisions or be used to inform therapeutic decisions). Where conducting the study involves additional invasive procedures or other risks to the study subjects. Performance studies that include diagnostic tests for therapeutic selection (that do not use leftover samples).
This type of performance study must be authorized by the competent authority of the country where it is to be conducted and approved by an Ethics Committee for Research (in the case of Spain authorization will be requested from AEMPS and a favorable opinion from the CEIm).
deviCE Sistemas can assist you in your performance study process.