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  • 1.  IFU change notification (EU)

    Posted 16-Aug-2022 06:13
    Hello,

    For me it is unclear, if all IFU changes (new versions) have to be reported/notified to the NB or only substantial changes.
    E.g., if we add a limitation to the intended use (in the limitations section) it is according to MCDG guidance not a substantial (not reportable) change (while it's not causing an increase of risk but reducing risk). Do we still need to share the new IFU version (any new version?) with the NB for approval?

    Thanks in advance for your help.

    Kind regards,
    Enrico

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    Enrico Schurig
    Epalinges
    Switzerland
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  • 2.  RE: IFU change notification (EU)

    Posted 17-Aug-2022 07:37
    Hello Enrico,

    There are a few other forum posts on changes in the EU for products, labelling, and IFU.  There is the MDCG guidance document 2020-3 which defines better those significant changes.  However, as mentioned in the other forum posts always refer to your Notified Body contract and usually most of them have a "change notification" form or requirements for what must be submitted.  Also if the product is still EU MDD certified, any change to products, no matter the change and no matter the significance, they are being very conservative on what needs notification.  Recommend you review the change notification requirements for your Notified Body.  An organisation can also communicate to the Notified Body on the change, give a timeline for implementation, and then implement if you feel it is not a significant change, but still want to notify them.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: IFU change notification (EU)

    Posted 17-Aug-2022 09:57
    Hello Enrico- I echo Richard's thoughts and wanted to add some insight from a recent experience. 

    We made a minor/non-significant update to an eIFU.  While it was non-significant, our contract with our Notified Body required notification of a change to the IFU.  We submitted the change form to the NB and provided all of the relevant information (change control documents, redlines, etc) and an assessment as to the impact of the change (i.e. non-significant per MDCG2020-3), to aid in the review.  We received a response confirming that the change was non-significant.  We included the NB as an attachment to our change control record.

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    Stephanie Chea Matias
    Director, Quality Systems & Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: IFU change notification (EU)

    This message was posted by a user wishing to remain anonymous
    Posted 17-Aug-2022 16:11
    This message was posted by a user wishing to remain anonymous

    Dear All,
    I want to switch the topic to register new IFU or amendment in 27 countries.

    We have the argument in the group whether to communicate to each competency group.

    I remember that France needs always notification.

    regards
    Original Message


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