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  • 1.  IVDR - Design and Manufacturing

    This message was posted by a user wishing to remain anonymous
    Posted 26-Mar-2020 16:41
    This message was posted by a user wishing to remain anonymous

    Hi
    Will a Notified Body require Design History Files and product work instructions with an IVDR Technical File submission?


  • 2.  RE: IVDR - Design and Manufacturing

    Posted 27-Mar-2020 02:52
    Depends on the class of IVD, but for class 3 and 4 expect the Notified Body to audit adequacy of design controls, just like for IIb and III medical devices.

    Incidentally, Australia has been living with the same system as now being introduced in the IVDR so we are already accustomed to the requirements.  Let me know if we can help.

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    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
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    Original Message


  • 3.  RE: IVDR - Design and Manufacturing

    Posted 27-Mar-2020 16:58
    Hello,

    Under the MDR and IVDR the requirement for Technical Documentation encompasses many technical information associated with the product including parts of the Design History File (DHF).  You are really looking at parts of the DHF that would be provided as part of the Technical Documentation review by a Notified Body.  The Technical Documentation would be structured as an index or summary document with references to the specific information contained in the DHF.  I definitely would not provide your entire DHF as part of the Technical Documentation as often times it is verification and validation testing that is important.  And for an IVD would be the performance analytical testing.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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