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  • 1.  Q&A on when the European IVDR regulation apply in clinical trials

    Community Leadership
    Posted 06-03-2022 05:25
      |   view attached

    Hi All,
    The attached Q&A was released recently to clarify when the European IVDR regulations (effective 26 May 2022) are applicable to assays used in the clinical trial space. This will likely impact biomarker assays used in precision medicine/patient identification and immunogenicity assays used to prescreen for entry into a trial, amongst many others...
    Thanks, 
    Rob



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    Robert Nelson
    Associate Director, Scientific Affairs
    Labcorp Drug Development
    Meyrin Switzerland
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer or other entities to which I am affiliated.
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    Attachment(s)

    pdf
    mdcg_2022-10_en_25 May 22.pdf   654 KB 1 version


  • 2.  RE: Q&A on when the European IVDR regulation apply in clinical trials

    Posted 06-14-2022 12:15
    Hi Rob,
    Thank you for sharing!!

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    Amanda Hays Ph.D.
    Scientific Officer
    BioAgilytix
    Olathe KS
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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    Original Message