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Review
. 2021 Feb 24:19:32-33.
doi: 10.1016/j.jmsacl.2021.02.001. eCollection 2021 Jan.

IVDR and diagnostic application of mass spectrometry in the European Union

Affiliations
Review

IVDR and diagnostic application of mass spectrometry in the European Union

Michael Vogeser. J Mass Spectrom Adv Clin Lab. .
No abstract available

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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

    1. 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.
    1. 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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    1. International standardization organization (ISO). Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014).
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