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Title:

Pre-analytical processes in medical diagnostics: New regulatory requirements and standards.

Document type:
Journal Article; Review
Author(s):
Dagher, Georges; Becker, Karl-Friedrich; Bonin, Serena; Foy, Carole; Gelmini, Stefania; Kubista, Mikael; Kungl, Penelope; Oelmueller, Uwe; Parkes, Helen; Pinzani, Pamela; Riegman, Peter; Schröder, Ulrike; Stumptner, Cornelia; Turano, Paola; Sjöback, Robert; Wutte, Andrea; Zatloukal, Kurt
Abstract:
In May 2017, the European In Vitro Diagnostic Regulation (IVDR) entered into force and will apply to in vitro diagnostics from May 26th, 2022. This will have a major impact on the in vitro diagnostics (IVD) industry as all devices falling under the scope of the IVDR will require new or re-certification. It will also affect health institutions developing and using in-house devices. The IVDR also has implications with respect to product performance validation and verification including the pre-ana...     »
Journal title abbreviation:
N Biotechnol
Year:
2019
Journal volume:
52
Pages contribution:
121-125
Fulltext / DOI:
doi:10.1016/j.nbt.2019.05.002
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/31102798
Print-ISSN:
1871-6784
TUM Institution:
Institut für Allgemeine Pathologie und Pathologische Anatomie
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