Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDR

Abstract

IVDs are a backbone of modern state-of-the-art medicine, especially forthcoming precision and personalized medicine; its reliability is of paramount importance for most medical disciplines, including for medical genetic testing, prediction, staging or diagnosis of cancer, or proper microbiological diagnosis. This holds true for individual as well as public health relevant diagnosis and covers both professional and lay use. It is therefore important that the performance of IVDs (both analytical and clinical) is always based on sufficient clinical evidence which can be demonstrated throughout the life cycle of these products (e.g., to address emerging new variants of infectious agents).

Performance evaluation of IVDs must therefore be put high on the agenda of modern regulatory attempts in Europe and globally. The European legislator had to create a well-anchored and sophisticated valid life cycle process for performance evaluation, benchmarking, and even improving the global guidelines of the International Medical Device Regulators Forum (IMDRF). Apart from proper scientific literature search, performance studies of IVDs will be the major source of valid scientific data to underpin the clinical evidence needed for an IVD.