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  • 1.  Documenting Non-significant changes for EU

    Posted 15-Aug-2022 10:22
    Hello Regulatory folks!

    How is everybody documenting 'non-significant' changes made to medical devices for the EU? Perhaps something similar to a Letter to File?

    Thanks!
    Aditi

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    Aditi Kinikar
    Regulatory Specialist
    United States
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  • 2.  RE: Documenting Non-significant changes for EU

    Posted 15-Aug-2022 12:06

    Hello Aditi-

    Apart from properly documenting the change in your Change Management System, I would recommend utilizing the guidance in MDCG 2020-3, Guidance on significant changes regarding  the transitional provision under Article 120  of the MDR with regard to devices covered  by certificates according to MDD or AIMDD, to assess and justify the change to the device. 

    A letter to file similar to those done for FDA could work as a good 'cover letter' for the technical file as the changes can be summarized and then linked directly to the change control record.  I like the decision trees in MDCG 2020-3 as they can be included as part of the assessment to show that all areas were considered.

    It should also be noted that, while the change may be determined to be non-significant, agreements with your NB could require notification of the change. 



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


  • 3.  RE: Documenting Non-significant changes for EU

    Posted 15-Aug-2022 13:19

    I recommend that you don't document them, sort-of.

    There is no requirement to document non-significant changes. The only requirement is to determine whether a change is significant as determined by your contract with your NB. In those case you need to submit the change to the NB before implementing it.

    A change to a device is a design change, so you should document it using your FDA QSR and EN ISO 13485:2016/A11:2020 design change process. If the change is non-significant, there is nothing else to do.

    The "sort of" part suggests you have a check list or decision tree to determine if the change is significant. Put the results in the design history file in the same manner you would document the decision that a change doesn't need a new 510(k).



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Documenting Non-significant changes for EU

    Posted 16-Aug-2022 09:12
    For most changes, I complete three memos. 1 is for FDA 510(k)notification, 2  is for MDR MDCG substantial change memo, and the last one is a risk review to document what's changing or not changing in the risk matrix.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 5.  RE: Documenting Non-significant changes for EU

    This message was posted by a user wishing to remain anonymous
    Posted 17-Aug-2022 09:12
    This message was posted by a user wishing to remain anonymous

    Can you share an example of the
    memo template?
    Original Message


  • 6.  RE: Documenting Non-significant changes for EU

    Posted 17-Aug-2022 01:44
    Hello Aditi,

    can you please elaborate more on "non-significant"?

    I.e. do you mean lesser changes in general, or changes that would not mandate, in the EU, a registration under the MDR?

    Kind regards,
    Matteo

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    Matteo Lostuzzo
    Bülach
    Switzerland
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    Original Message


  • 7.  RE: Documenting Non-significant changes for EU

    Posted 25-Aug-2022 08:29
    Hello Matteo,
    Yes, I mean minor changes that do not impact intended use/safety/effectiveness and that would not trigger a registration update.

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    Aditi Kinikar
    Beachwood OH
    United States
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    Original Message


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