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Structure and content of the EU-IVDR: Current status and implications for pathology

BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new...

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Detalles Bibliográficos
Autores principales:	Kahles, Andy, Goldschmid, Hannah, Volckmar, Anna-Lena, Ploeger, Carolin, Kazdal, Daniel, Penzel, Roland, Budczies, Jan, Kempny, Gisela, Kazmierczak, Marlon, Flechtenmacher, Christa, Baretton, Gustavo, Weichert, Wilko, Horst, David, Klauschen, Frederick, Gassner, Ulrich M., Brüggemann, Monika, Vogeser, Michael, Schirmacher, Peter, Stenzinger, Albrecht
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer Medizin 2023
Materias:	Review Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896441/ https://www.ncbi.nlm.nih.gov/pubmed/36735063 http://dx.doi.org/10.1007/s00292-022-01176-z

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