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Titel:

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

Dokumenttyp:
English Abstract; Journal Article; Review
Autor(en):
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...     »
Zeitschriftentitel:
Pathologe
Jahr:
2020
Band / Volume:
41
Heft / Issue:
Suppl 2
Seitenangaben Beitrag:
129-133
Volltext / DOI:
doi:10.1007/s00292-020-00867-9
PubMed:
http://view.ncbi.nlm.nih.gov/pubmed/33263810
Print-ISSN:
0172-8113
TUM Einrichtung:
Institut für Allgemeine Pathologie und Pathologische Anatomie
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