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Title:

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

Document type:
Review; Journal Article; Review
Author(s):
Kahles, Andy; Goldschmid, Hannah; Volckmar, Anna-Lena; Plöger, Carolin; Kazdal, Daniel; Penzel, Roland; Budczies, Jan; Kempny, Gisela; Kazmierczak, Marlon; Flechtenmacher, Christa; Baretton, Gustavo; Weichert, Wilko; Horst, David; Klauschen, Frederick; Gassner, Ulrich M; Brüggemann, Monika; Vogeser, Michael; Schirmacher, Peter; Stenzinger, Albrecht
Abstract:
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 and a later date of application of some requirements for in-house devices for healthcare facilities, was adopted on 15 December...     »
Journal title abbreviation:
Pathologie (Heidelb)
Year:
2022
Journal volume:
43
Journal issue:
5
Pages contribution:
351-364
Fulltext / DOI:
doi:10.1007/s00292-022-01077-1
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/35925306
Print-ISSN:
2731-7188
TUM Institution:
Institut für Allgemeine Pathologie und Pathologische Anatomie
 BibTeX