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The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories.

作者信息

Lubbers Bart R, Schilhabel Anke, Cobbaert Christa M, Gonzalez David, Dombrink Isabel, Brüggemann Monika, Bitter W Marieke, van Dongen Jacques J M

机构信息

Department of Immunology, Leiden University Medical Center, Leiden, The Netherlands.

Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany.

出版信息

Hemasphere. 2021 Apr 21;5(5):e568. doi: 10.1097/HS9.0000000000000568. eCollection 2021 May.

DOI:10.1097/HS9.0000000000000568
PMID:33898932
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8061679/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/9545c155080a/hs9-5-e568-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/8fce21605130/hs9-5-e568-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/3c099c0cb9d3/hs9-5-e568-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/9545c155080a/hs9-5-e568-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/8fce21605130/hs9-5-e568-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/3c099c0cb9d3/hs9-5-e568-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/31c2/8061679/9545c155080a/hs9-5-e568-g006.jpg

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The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.
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