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  • 1.  Recall and Advisory for EU

    This message was posted by a user wishing to remain anonymous
    Posted 30-May-2019 12:06
    This message was posted by a user wishing to remain anonymous

    ​Hello All,

    I am writing a procedure for recall and advisory specifically to cover EU. I have few questions regarding that.

    1) Is the RA responsible for interfacing just with EU AR or has to communicate with the NB?
    - I believe if a recall is applicable, a FSCA should be filed with the authorized rep and they take care of communicating it with the notified body?

    2) Recall communication - Annex 5 FSCA template should be communicated to whom?

    3)  Closing the recall - Which Annex explains the process. I believe a safety officer is assigned and the competent authority agrees on the termination of the reportable complaint. It is recommended that an official closure letter is received from the competent authority closing the complaint.


  • 2.  RE: Recall and Advisory for EU

    Posted 30-May-2019 16:00

    Using the EU-MDR terminology, which may not match the MDD, will help clarify the situations.

     

    The MDR doesn't use the word recall, instead it uses Field Safety Corrective Action, FSCA. According to Art. 87(1) the manufacturer reports the FSCA to the Competent Authority through Eudamed.

    It is unlikely that the form in MedDev 2.12-1 Rev 8 will apply. There is a new form for the Manufacturer's Incident Report, which went into effect on Jan. 1, 2019. I expect there will be, in due course, a new form for the FSCA. Also note that there are additional forms for the FSN including forms for customer and distributor replies.

    Article 89 describes the process for FSCA analysis and the final report. Notice that you are closing a complaint, but an FSCA; they are different.

    Annex VII(4.3) requires that the contract between the manufacturer and the NB include "an obligation on the manufacturer to inform the notified body of vigilance reports". The FSCA and FSN are vigilance reports.

    Article 11 doesn't require that the manufacturer inform the Authorized Representative of an FSCA, but the AR must, "cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices". This would imply that the manufacturer keeps the AR informed.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 3.  RE: Recall and Advisory for EU

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2019 10:29
    This message was posted by a user wishing to remain anonymous

    ​Thank you for a quick response!
    Would it be possible for you to share the current manufacturer's incident report form and the customer and distributor form as well? 

    So, if the manufacturer does not have to inform authorized rep of an FSCA how do they get involved in Corrective or preventive actions to eliminate the risks posed by devices? How do we ensure that communication in our procedures?

    Thanks!


  • 4.  RE: Recall and Advisory for EU

    Posted 31-May-2019 11:36

    To get the forms go to https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en

    Open the section call Guidance MEDDEVs

    Scroll down to section 2.12 Post-Market surveillance

    Under Other forms and templates you will see the FSN forms

    Under New MIR form - as from January 2019 you will see the new MIR and the instructions.

    You ask, "if the manufacturer does not have to inform authorized rep of an FSCA how do they get involved in Corrective or preventive actions to eliminate the risks posed by devices?"

    You tell the authorized rep. You should copy the NB and the authorized rep on all communication you have with a Competent Authority.

    You should copy the authorized rep on all communication you have with the NB.

    In the best case, when you submit an FSCA to the Competent Authority, Eudamed will send it to the Authorized Rep and the NB. However, I would not rely on that method.

    How do we ensure that communication in our procedures?

    Your procedure should include the elements of reporting to regulators:

    Trigger – What causes you to create the report

    Timing – What is allowable time from the trigger until the report reaches the regulator

    Recipient – Who receives the report

    Transmission – How do you send the report to the regulator

    Record – What information must be in the quality record (it is often more than just the report)

    Retention – How long do you retain the quality record

     

    Under recipient, include the NB and the Authorized Representative

    Under transmission, identify how you will send it to those recipients



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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