Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung - Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023

In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became c...

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Bibliographic Details
Published in:German medical science Vol. 22; p. Doc01
Main Authors: Vogeser, Michael, Brüggemann, Monika, Brandt, Kristina, Ceglarek, Uta, Gieskes, Volker, Hitziger, Niclas, Kahles, Andy, Klar, Ernst, Roggenbuck, Dirk, Schliephake, Henning, Schulte, Ortwin, Wettmarshausen, Sascha, Zimmermann, Uwe, Sack, Ulrich, Stenzinger, Albrecht
Format: Journal Article
Language:English
Published: Germany German Medical Science GMS Publishing House 2024
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Summary:In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.
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ISSN:1612-3174
DOI:10.3205/000327