IVDR and diagnostic application of mass spectrometry in the European Union
- PMID: 34820663
- PMCID: PMC8601008
- DOI: 10.1016/j.jmsacl.2021.02.001
IVDR and diagnostic application of mass spectrometry in the European Union
Conflict of interest statement
The author declares that he has no competing financial interests or personal relationships that could have appeared to influence the viewpoints reported in this paper.
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References
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- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj.
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- Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union -Available from: http://data.europa.eu/eli/treaty/teu_2012/oj.
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- International standardization organization (ISO). Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014).
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- Vermeersch P., Van Aelst T., Dequeker E.M.C. The new IVD Regulation 2017/746: a case study at a large university hospital in Belgium demonstrates the need for clarification on the degree of freedom laboratories have to use lab-developed tests to improve patient care. Clin. Chem. Lab. Med. 2020 /j/cclm.ahead-of-print/cclm-2020-0804/cclm-2020-0804.xml. doi: 10.1515/cclm-2020-0804. Online ahead of print. - PubMed
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