Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR)

In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scie...

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Detalles Bibliográficos
Autores principales: Hoffmüller, Petra, Brüggemann, Monika, Eggermann, Thomas, Ghoreschi, Kamran, Haase, Detlef, Hofmann, Jörg, Hunfeld, Klaus-Peter, Koch, Katharina, Meisel, Christian, Michl, Patrick, Müller, Jens, Müller, Carsten, Rabenau, Holger F., Reinhardt, Dirk, Riemenschneider, Markus J., Sachs, Ulrich J., Sack, Ulrich, Stenzinger, Albrecht, Streichert, Thomas, von Neuhoff, Nils, Weichert, Wilko, Weinstock, Christof, Zimmermann, Stefan, Spitzenberger, Folker
Formato: Online Artículo Texto
Lenguaje:English
Publicado: German Medical Science GMS Publishing House 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8204380/
https://www.ncbi.nlm.nih.gov/pubmed/34194291
http://dx.doi.org/10.3205/000295

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