MDCG-2019-11. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. 2019

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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) Translated title: Stellungnahme der Ad-hoc-Kommission In-vitro-Diagnostika der AWMF zur Umsetzung der Verordnung (EU) 2017/746 (IVDR) im Hinblick auf In-vitro-Diagnostika aus Eigenherstellung
Authors: Petra Hoffmüller, Monika Brüggemann, Thomas Eggermann …

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