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Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force.

作者信息

Dombrink Isabel, Lubbers Bart R, Simulescu Loredana, Doeswijk Robin, Tkachenko Olga, Dequeker Elisabeth, Fraser Alan G, van Dongen Jacques J M, Cobbaert Christa, Brüggemann Monika, Macintyre Elizabeth

机构信息

BioMed Alliance Task Force on In Vitro Diagnostics, Brussels, Belgium.

Ad hoc Commission IVD of the Association of the Scientific Medical Societies in Germany, Berlin, Germany.

出版信息

Hemasphere. 2022 May 20;6(6):e724. doi: 10.1097/HS9.0000000000000724. eCollection 2022 Jun.

DOI:10.1097/HS9.0000000000000724
PMID:35620593
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9126521/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/37c401c1858d/hs9-6-e724-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/f82afd54d0d1/hs9-6-e724-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/01abb52b24be/hs9-6-e724-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/bd4ab854096d/hs9-6-e724-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/37c401c1858d/hs9-6-e724-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/f82afd54d0d1/hs9-6-e724-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/01abb52b24be/hs9-6-e724-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/bd4ab854096d/hs9-6-e724-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3daa/9126521/37c401c1858d/hs9-6-e724-g004.jpg

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本文引用的文献

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Laboratory-Developed Tests in the New European Union 2017/746 Regulation: Opportunities and Risks.欧盟2017/746新法规中的实验室自建检测：机遇与风险
Clin Chem. 2021 Dec 30;68(1):40-42. doi: 10.1093/clinchem/hvab215.
2
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Clin Chem Lab Med. 2021 Sep 15. doi: 10.1515/cclm-2021-0975.
3
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).
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Diagnostics (Basel). 2023 Sep 11;13(18):2910. doi: 10.3390/diagnostics13182910.
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Targeted High-throughput Sequencing for Hematological Malignancies: A GBMHM Survey of Practice and Cost Evaluation in France.血液系统恶性肿瘤的靶向高通量测序：法国GBMHM实践与成本评估调查
Hemasphere. 2023 Aug 24;7(9):e943. doi: 10.1097/HS9.0000000000000943. eCollection 2023 Sep.
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[Work Group of the Scientific Medical Societies].
Unfallchirurgie. 1992 Feb;18(1):55-6. doi: 10.1007/BF02588242.