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Consequences of the EU IVDR implementation for medical laboratories


Authors: F. Spitzenberger 1,2
Authors‘ workplace: Centre for Regulatory Affairs in Biomedical Sciences, Technische Hochschule Lübeck, Mönkhofer Weg 239, 23562 Lübeck, Germany 1;  Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE, Mönkhofer Weg 239 a, 23562 Lübeck, Germany 2
Published in: Klin. Biochem. Metab., 32, 2024, No. 1, p. 4-6
Category: Review articles
doi: https://doi.org/10.61568/kbm.2024.002

Overview

With the entry into force of the European Regulation (EU) 2017745 (“IVDR”) on May 26th 2022, drastic changes have occurred for practically all stakeholders in the field of in vitro diagnostic medical devices (IVD) [1]...


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Clinical biochemistry Nuclear medicine Nutritive therapist
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