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  • 1.  IVDR: CE mark requirement for Eppendorf tubes?

    This message was posted by a user wishing to remain anonymous
    Posted 02-20-2025 11:56
    This message was posted by a user wishing to remain anonymous

    For our on-going clinical study in Europe, a partner/vender requested that a specific Eppendorf tube used for biomarker sample collections need to be CE marked due to the new IVDR regulation.  My understanding is that the IVDR regulation applies to In Vitro Diagnostic Medical Devices, not general laboratory supplies.  Any comments or advice?   Thanks!



  • 2.  RE: IVDR: CE mark requirement for Eppendorf tubes?

    Posted 02-21-2025 09:42

    ARGO. that is, I think this is an extreme request that should not have been made. And that should be discounted as nonsense. Michael P. has better/nicer arguments in his reply. The substance is the same

     

    Michele (he, him)

     

     




    Original Message


  • 3.  RE: IVDR: CE mark requirement for Eppendorf tubes?

    Posted 02-21-2025 11:47

    Some vendors have been misinformed about this issue with (some) consultants and lawyers giving incorrect advice. Unless a specific sample storage tube is crtitcal for the performance of the diagnostic test, then CE marking is not required. Obviously you can take this to extremes and require all steps in storage and transport of a sample for an diagnostic test to be CE marked, but this is clearly not the intent of  the EU IVD Regs. 



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    Michael Partridge
    Senior Director
    Regeneron Pharmaceuticals
    Tarrytown NY
    [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