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Review
. 2020 Dec;41(Suppl 2):129-133.
doi: 10.1007/s00292-020-00867-9.

[Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What's important?]

[Article in German]
Albrecht Stenzinger  1 , Wilko Weichert  2
Affiliations
Review

[Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What's important?]

[Article in German]
Albrecht Stenzinger et al. Pathologe. 2020 Dec.

Abstract
in English, German

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.

Im Jahr 2022 tritt die neue In-vitro-Diagnostik-Regulation (IVDR) der EU in Kraft. Das komplexe Regelwerk ist darauf ausgerichtet, die Herstellung und das Inverkehrbringen von In-vitro-Diagnostika durch Firmen strikter zu regulieren und enger zu monitoren. Neben zahlreichen Anforderungen an die methodische Entwicklung spielt hier insbesondere auch die nun neu geforderte klinische Validität der Assays und ein neues Vigilanzsystem eine zentrale Rolle. Im Rahmen dieser Neuordnung der Diagnostiklandschaft wird zudem das Feld der laborentwickelten Tests (LDT) in erheblichem Umfang mitgeregelt. Die zu LDTs erlassenen neuen Bestimmungen werden die Pathologie vor zahlreiche neue Herausforderungen stellen, die nun zu bewältigen sind, um einen Engpass im Einsatz von Diagnostika zu verhindern. In diesem Artikel werden verschiedene Aspekte der IVDR mit Blick auf die morphologische und molekulare Diagnostik in der Pathologie diskutiert.

Keywords: Diagnostic Assays; EU; IVDR; LDT; Pathology.

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