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

Ger Med Sci. 2024 Jan 29;22:Doc01. doi: 10.3205/000327. eCollection 2024.ABSTRACTIn 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.PMID:38515785 | PMC:PMC10952015 | DOI:10.3205/000327

Source: GMS German Medical Science - March 22, 2024 Category: General Medicine Authors: Michael Vogeser Monika Br üggemann Kristina Brandt Uta Ceglarek Volker Gieskes Niclas Hitziger Andy Kahles Ernst Klar Dirk Roggenbuck Henning Schliephake Ortwin Schulte Sascha Wettmarshausen Uwe Zimmermann Ulrich Sack Albrecht Stenzinger Arbeitsgemeinsch Source Type: research