Performance Evaluations and
Performance Studies of In Vitro Diagnostics
Performance evaluation is a targeted process to demonstrate the analytical and clinical performance of your IVD medical device. Moreover, the evaluation should be continuously updated using PMPF measures.
Scientific – Analytical – Clinical
Goal-oriented evaluation of your IVD medical device, supported by CERES.
In vitro diagnostic medical devices make a significant contribution to treatment control and diagnostics. Consequently, it is important to evaluate IVD devices performance and usability, so that an objectified and informed application can take place. According to regulation (EU) 2017/746 on in vitro diagnostics (IVDR) necessary evidence on performance and safety should appropriately support the intended purpose of a device as stated by the manufacturer. Guided by the performance evaluation plan (PEP) the performance evaluation results in a performance evaluation report (PER) demonstrating scientific validity as well as analytical and clinical performance.
… has to demonstrate the 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. As stated by the manufacturer and in particular, where applicable: diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, likelihood ratio, expected values in normal and affected populations should be addressed. Taking into account most recent and general principles on clinical evidence, e.g. MDCG 2022-2, ensures appropriateness and improves acceptance.
…has to demonstrate the ability of a device to correctly detect or measure a particular analyte. Taking into account applicability and general methodological principles, evaluations particularly address 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 and even more.
… has to demonstrate the association of an analyte with a clinical condition or a physiological state. Therefore, the scientifically proven association must be documented. If available, through the use of existing data, while taking into account the generally acknowledged state-of-the-art. If the association of the analyte to a clinical condition or physiological state is well established, evidence may be available in sufficient quality and quantity to substantiate the scientific validity. Otherwise, a gap analysis should be conducted by the manufacturer in order to determine the additional evidence required.
Appropriateness of the support of the intended purpose depends on the classification of the device. According to regulation (EU) 2017/746 on in vitro diagnostics (IVDR) seven specific rules have to be applied to assign one of the four different risk classes (A, B, C or D) to the IVD. Risk class A describes the lowest risk. However, about 4 of 5 devices will be assigned to a risk class higher than class A, which results in higher documentation efforts and involvement of a notified body.
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