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
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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