Einfluss der neuen In-vitro-Diagnostik-Regulation (IVDR) der Europäischen Union auf die Pathologie. Was ist wichtig?

In 2022 the new in vitro diagnostic regulation (IVDR) of the European Union will come into full effect. This complex regulatory framework aims at a stricter regulation and monitoring of industrial diagnostic assay production. The IVDR defines many new methodological requirements and includes an additional entirely new focus on the clinical validity of diagnostic assays as well as a novel tighter vigilance system. Although not the core of the regulation, the whole field of laboratory developed tests (LDTs) is also subject to fundamental restructuring within this regulatory framework. The respective requirements are broad and will pose many challenges to assay developers and users in pathology. The many new aspects of LDT production and use must be properly addressed to avoid a bottleneck in diagnostic assay availability. In this article, the impact of the different aspects of the IVDR on European pathology laboratories will be discussed.