Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.

Autor:	Kahles A; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Goldschmid H; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Volckmar AL; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Kazdal D; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Gassner UM; Faculty of Law, Augsburg University, Augsburg, Germany., Vogeser M; Institute of Laboratory Medicine, LMU University Hospital, LMU Munich, Germany., Brüggemann M; Clinic for Internal Medicine II, Section for Special Hematology Diagnostics, University Hospital Schleswig-Holstein, Kiel, Germany., Bürrig KF; Professional Association of German Pathologists, registered association, Berlin, Germany., Kääb-Sanyal V; Professional Association of German Pathologists, registered association, Berlin, Germany., Flechtenmacher C; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Schirmacher P; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany., Stenzinger A; Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.
Jazyk:	angličtina
Zdroj:	German medical science : GMS e-journal [Ger Med Sci] 2024 Oct 11; Vol. 22, pp. Doc09. Date of Electronic Publication: 2024 Oct 11 (Print Publication: 2024).
DOI:	10.3205/000335
Abstrakt:	Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR) resulted in a need for regulatory adjustments to German medical device law. This has created a new legal framework in which institutes for pathology operate, depending on their function as users, operators or in-house manufacturers of in vitro diagnostic medical devices. This overview of the current legal situation represents a snapshot and provides an up-to-date overview of the landscape of European and German medical device law. Competing Interests: Andy Kahles: There is no conflict of interest.Hannah Goldschmid: There is no conflict of interest.Anna-Lena Volckmar: Personal fees from AstraZeneca and Novartis unrelated to the submitted workDaniel Kazdal: There is no conflict of interest.Ulrich M. Gassner: There is no conflict of interest.Peter Schirmacher: There is no conflict of interest.Albrecht Stenzinger: Advisory Board/Talk: AGCT, Aignostics, AstraZeneca, Bayer, BMS, Eli Lilly, Illumina, Incyte, Janssen, MSD, Novartis, Pfizer, Roche, Seattle Genetics, Takeda, Thermo Fisher; Grants: Bayer, BMS, Chugai, IncyteKarl-Friedrich Bürrig: There is no conflict of interest.Vanessa Kääb-Sanyal: There is no conflict of interest.Christa Flechtenmacher: There is no conflict of interest.Michael Vogeser: There is no conflict of interest.Monika Brüggemann: There is no conflict of interest. (Copyright © 2024 Kahles et al.)
Databáze:	MEDLINE
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