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)

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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Bibliographic Details
Main Authors: 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, AWMF Ad hoc Commision In-vitro Diagnostic Medical Devices
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2021-06-01
Series:GMS German Medical Science
Subjects:
ivdr
laboratory-developed tests
in-house ivd
validation
performance evaluation
quality management
Online Access:http://www.egms.de/static/en/journals/gms/2021-19/000295.shtml

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