Regulatory Open Forum

 View Only

  • 1.  NC from Notified Body audit

    Posted 20-Jun-2023 05:01

    We received during our last external audit following NC from our notified body wrt MDR article 83.4

    4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87.

    The NC was states as

    Article 83.4 is not addressed in the procedure and/or used templates.

     

    So, our NB wants that we formalize in our internal PMS procedure that if we launch a CAPA to investigate anything resulting from PMS, that we should inform the competent authority

    What are competent authorities expecting for this article and. If they want those to be reported, in which format needs this to be done?

    CAPAs could be raised for further improvements, without that there was a risk to the patient nor the physician à Are those needed to be reported ?

    To be clear we are here not talking about vigilance cases where a reporting needs to be done conform Article 87

    We are bringing class IIa SW products on the market under the MDR



    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------


  • 2.  RE: NC from Notified Body audit

    Posted 20-Jun-2023 07:41

    Start with Art. 86(1). It says that the PSUR includes "a rationale and description of any preventive and corrective actions taken".

    These are the corrective and preventive actions about which Art. 83(4) wants you to inform the competent authorities concerned.

    More to the point, these are the only ones about which you should inform.

    Your check is that for every corrective or preventive action in the PSUR, you should have a record of reporting to the competent authorities concerned.

    My recommendation for reporting is to keep it simple. Create a stock sentence such as, "<company> has initiated a <corrective> <preventive> action identified through post-market surveillance related to <short description>" that you send by e-mail.

    Let the CA come back with a request for more information.

    I see this as part of the market surveillance roles of a CA. It will know if it needs to proceed further.

    As always, copy the NB.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 3.  RE: NC from Notified Body audit

    Posted 20-Jun-2023 10:20

    Article 86: Periodic safety update report 

    Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report ('PSUR') for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken.

    PSUR  for each device or group , you can summaries with rationale and CAPA activity in a simple record, as Dan  mentioned simple non complicated standard template  would be best option. 



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 4.  RE: NC from Notified Body audit

    Posted 20-Jun-2023 11:32

    Hi Franky

    This seems to me another example of confusion created by different interpretations of each clause in the MDR. If your NB is requiring you to add a CAPA reporting requirement in the PMS procedure, then there should be clearly defined criteria, roles/responsibilities and, as appropriate, linkage to other reporting requirements in other procedures. This can create a lot of complexity and confusion in individual procedures. 

    Would they be open to a single, consolidated procedure for CA/NB reporting requirements, that can include references to appropriate procedures which could trigger a need to report? 

    I think everyone is trying to figure out how to comply with so many requirements of the MDR. Everyone seems to have a different interpretation!

    I wonder if the Notified Bodies are working towards creating common expectations for the industry to avoid so much of non-value added work simply to check a box.



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
    ------------------------------

    Original Message


Related Content