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  • 1.  Performance Evaluation standard for IVD studies

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jul-2021 08:43
    This message was posted by a user wishing to remain anonymous

    Hello RAPS Community

    How important is it to follow BS EN 13612 when running an IVD clinical study under the IVDD? I noticed that this standard is no longer in the harmonized list of standards even though it is still around. 

    Thank you.


  • 2.  RE: Performance Evaluation standard for IVD studies

    Posted 02-Aug-2021 15:40
    Hello Anon,

    The most current standard to use for IVD clinical performance studies is ISO 20916:2019.  The BS EN 13612 is pretty out-dated now, and ISO 20196 is a more currently one to use.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Performance Evaluation standard for IVD studies

    Posted 03-Aug-2021 10:30
    Edited by Christie Hughes 03-Aug-2021 10:30
    Hi Anon,

    I second Richard's response. Many still reference BS EN 13612, but it does not provide much guidance. ISO 20916:2019 is the most recent standard issued that provides guidance for IVD clinical studies. Compliance against this will become expected for devices in the EU under the IVDR, and I suspect many regulators will begin to, whether officially or unofficially, uphold IVD clinical studies to the requirements outlined in ISO 20916:2019 as it is rare to find guidance and standards specific for IVD clinical studies.

    Kind regards,
    Christie

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    Christie Hughes MT(ASCP), MPH
    Senior Consultant, Qserve Group
    Austin, TX
    United States
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    Original Message


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