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  • 1.  Reporting substantial change to Notified Body

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2017 11:22
    This message was posted by a user wishing to remain anonymous

    Hi,

    I have some questions on reporting substantial change to Notified Body.
    1. What constitute a substantial change? When you identify a substantial change, when is the best time to notify your NB regarding this? Many people mentioned that it should be done prior to making changes, so that the NB will tell what information required (e.g. clinical trial and what not).

    2. Does adding one function block to the software consider as substantial change? This add of function will change the claims (e.g. original software able to diagnose A, with the added function it can now diagnose A + B).

    3. Does changing the device exterior design consider as substantial change?

    4. Does changing the PCB firmware consider as substantial change?


    Thanks in advance!


  • 2.  RE: Reporting substantial change to Notified Body

    Posted 26-Jan-2017 03:17
    Hello, you can refer to the NB-MED recommendation “Reporting of design changes and changes of the quality system”, NB-MED/2.5.2/Rec2. Basically the guidance says that changes are “substantial“ and the manufacturer must inform the Notified Body if the change would affect conformity with:

    (a) the essential requirements and/or

    (b) the conditions prescribed for the intended use of the device
    So you need to check if the intended use is changed (new indications? new group of patients? etc.) and you need to go through you essential requirement checklist and identify if you need to add new means to proof conformity (for example new standards).

    Hope it helps

    Best regards




    ------------------------------
    Caterina Brusasco
    IBA
    Louvain La Neuve
    Belgium
    ------------------------------

    Original Message


  • 3.  RE: Reporting substantial change to Notified Body

    Posted 26-Jan-2017 04:06

    Hello,
    Agree with Caterine, check the NB-MED recommendation. It looks like you have a design change and you're also changing the intended use of your device.  This will classify as a substantial/major change and will need to be cleared with your NB before you proceed with implementation.
    Your Technical File will have to be updated and key elements (and respective STED) will need to be revised: your CER; revise your ERC to see if you still comply with all the requirements, revise your labeling (you might have to update your IFU), new DoC, check if there will be changes to the scope of your CE certificate (if applicable), etc. Get advice from your NB and best to have a plan and timelines together for this.

    Hope this helps

    Kind regards

    Ana



    ------------------------------
    Ana Cruz
    Johnson & Johnson Medical Ltd
    Wokingham
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: Reporting substantial change to Notified Body

    Posted 27-Jan-2017 03:17
    I also agree with Catarina, however I understand the NB-MED document she references was further developed - and may even be superseded - by this 2014 NBOG Best Practices Guide: http://www.doks.nbog.eu/Doks/NBOG_BPG_2014_3.pdf

    ------------------------------
    Oliver Bisazza
    Director, Regulatory Policy, EMEA
    Medtronic
    Brussels
    Belgium
    ------------------------------

    Original Message


  • 5.  RE: Reporting substantial change to Notified Body

    Posted 26-Jan-2017 08:54
    Hi anonymous,
    here below are answers to your questions which may need adapting according to specific cases.
    1. When a change is substantial, you have to notify it to your NB before making it available for use. This rule does not apply to low risk class products which do not require NB oversight.

    2. It sounds very much like the SW change you are considering does require a notification to the NB prior to market.

    3. Usually not. If the change is just "cosmetics", and does not affect usability nor does implicitly affect the intended use, then no need to notify the NB.

    4. Change is SW or FW: it depends on the consequences of the change. New functionality? New performances? New risks added?

    Regards

    ------------------------------
    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom
    ------------------------------

    Original Message


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