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  • 1.  CE Marking a component of an already CE marked IVD

    Posted 25-Sep-2018 15:55

    Hi all, 

    I have a question regarding the CE Marking of an individual component of an already CE Marked IVD Kit. 
    We are wanting to sell the component individually, so we are going through the process of CE Marking it. The question is regarding Instructions for use (IFU).
    Since it will be sold separately, does it need to have its own IFU (as a component)? Or can the IFU from the kit be used for the sale of the individual component?  

    Thank you in advance,



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    Matheus Falceta Martellet
    Regulatory Affairs Scientist
    Norman OK
    United States
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  • 2.  RE: CE Marking a component of an already CE marked IVD

    Posted 25-Sep-2018 23:19
    Hi there,

    I work in IVD space and for our products we have IFU for each of the components like buffers,calibrators,controls etc. since they are sold separately other than the instrument itself. So mostly yes it should IFU depending on what component it is. If you haven't checked the US FDA regulations like 21 CFR 809 should give you additional guidance and perspective when you might get ready to market in US. Hope this helps.
    Thanks

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    Jinali Bhavsar RAC
    Regulatory Affairs Specialist
    San Jose CA
    United States
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    Original Message


  • 3.  RE: CE Marking a component of an already CE marked IVD

    Posted 26-Sep-2018 05:49
    If you are taking a component from a kit that you will also sell individually, it would be recommended to have a separate IFU - at least a "small" one to link back to the main IVD test.  I used to do the same where we had different components like calibrators or check solutions that were sold separately because they were not needed with the IVD test kit each time.  We did make sure this IFU stated when it could/should be used and that is was used only with our product for purpose of a, b, c, etc.  You would not need the full-blown IFU like the IVD kit has, but a minimum amount for identity, how to use, what to use it with, and any other information as pointed out previously that would be required under 21 CFR 809 or other labelling requirements.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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