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Title:

[Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What's important?]

Document type:
English Abstract; Journal Article; Review
Author(s):
Stenzinger, Albrecht; Weichert, Wilko
Abstract:
In 2022 the new in vitro diagnostic regulation (IVDR) of the European Union will come into full effect. This complex regulatory framework aims at a stricter regulation and monitoring of industrial diagnostic assay production. The IVDR defines many new methodological requirements and includes an additional entirely new focus on the clinical validity of diagnostic assays as well as a novel tighter vigilance system. Although not the core of the regulation, the whole field of laboratory developed te...     »
Journal title abbreviation:
Pathologe
Year:
2020
Journal volume:
41
Journal issue:
Suppl 2
Pages contribution:
129-133
Fulltext / DOI:
doi:10.1007/s00292-020-00867-9
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/33263810
Print-ISSN:
0172-8113
TUM Institution:
Institut für Allgemeine Pathologie und Pathologische Anatomie
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