Structure and content of the EU-IVDR : Current status and implications for pathology.

Autor: Kahles A; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany. andy.kahles@med.uni-heidelberg.de., Goldschmid H; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Volckmar AL; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Ploeger C; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Kazdal D; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Penzel R; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Budczies J; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Kempny G; Professional Association of German Pathologists, Bundesverband Deutscher Pathologen e. V., Berlin, Germany., Kazmierczak M; Professional Association of German Pathologists, Bundesverband Deutscher Pathologen e. V., Berlin, Germany., Flechtenmacher C; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Baretton G; Department of Pathology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany., Weichert W; Institute of Pathology, Technical University of Munich, Munich, Germany., Horst D; Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin, Germany., Klauschen F; Institute of Pathology, Ludwig-Maximilian University of Munich, Munich, Germany., Gassner UM; Faculty of Law, University of Augsburg, Augsburg, Germany., Brüggemann M; 2nd Internal Medicine Department, Hematology Lab Kiel, University Hospital Schleswig-Holstein (UKSH), Kiel, Germany., Vogeser M; Institute of Laboratory Medicine, Ludwig-Maximilian University of Munich, Munich, Germany., Schirmacher P; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Stenzinger A; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany. albrecht.stenzinger@med.uni-heidelberg.de.
Jazyk: angličtina
Zdroj: Pathologie (Heidelberg, Germany) [Pathologie (Heidelb)] 2023 Nov; Vol. 44 (Suppl 2), pp. 73-85. Date of Electronic Publication: 2023 Feb 03.
DOI: 10.1007/s00292-022-01176-z
Abstrakt: Background: Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was passed by the European Parliament and the Council of the European Union on 5 April 2017 and came into force on 26 May 2017. A new amending regulation, which introduces a phased implementation of the IVDR with new transitional provisions for certain in vitro diagnostic medical devices (IVDs) and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December 2021. The combined use of CE-certified IVDs (CE-IVDs), in-house IVDs (IH-IVDs), and research use only (RUO) devices are a cornerstone of diagnostics in pathology departments and crucial for optimal patient care. The IVDR not only regulates the manufacture and placement on the market of industrially manufactured IVDs, but also imposes conditions on the manufacture and use of IH-IVDs for internal use by healthcare facilities.
Objectives: Our work provides an overview of the background and structure of the IVDR and identifies core areas that need to be interpreted and fleshed out in the context of the legal framework as well as expert knowledge.
Conclusions: The gaps and ambiguities in the IVDR crucially require the expertise of professional societies, alliances, and individual stakeholders to successfully facilitate the implementation and use of the IVDR in pathology departments and to avoid aberrant developments.
(© 2023. The Author(s).)
Databáze: MEDLINE
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