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  • 1.  NB timelines to release a CE marking certificate

    Posted 04-May-2022 03:00
    Dear regulatory experts,
    A notified body released positive feedback regarding a CE marking audit. However, one year passed, and the certificate has not released.
    Several reminders didn't get any reaction other than "we are working on it".
    There is no clause regarding the timeline for releasing the CE marking after a positive audit in the contract.
    Based on your experience, is there any rule or NB code of conduct I can consult to push more and get the certificate?

    Looking forward to your thankful contribution,

    ------------------------------
    Mauro
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  • 2.  RE: NB timelines to release a CE marking certificate

    Posted 04-May-2022 07:55
    Dear Marco,

    The performance of your Notified Body is not just unacceptable its also a high business risk and a distortion of competition. At Notified Body Operations Group (NBOG) you will find a contact list where you can report the bad performance of a notified body. You will receive an acknowledgment within 5 days and with a timeline of their investigation.

    In their Designating Authorities Handbook(s) you will find the contact list and details on page 14 :
    https://www.nbog.eu/nbog-documents/

    All the best!
    Martin


    ------------------------------
    Martin Eberl
    Pliening
    Germany
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    Original Message


  • 3.  RE: NB timelines to release a CE marking certificate

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2022 10:04
    This message was posted by a user wishing to remain anonymous

    Thank you for this information and this link. I am experiencing a similar issue with my NB. 
    2020 was my Re-certification audit, but because it was 100% virtual, the certificates were issued with only a one year expiry date. 
    Our 1.Surveillance audit was Fall 2021. Audit findings were minor, accepted, and closed. I have since been waiting for our NB to release a simple renewal EN/ISO 13485 certificate- no CE/EC, no MDR, no MDSAP....Just a simple EN/ISO 13485 renewal. I was told in December our audit/review was placed on a priority list. It is now May 2022 and I am still waiting. 
    This delay has caused so much stress and placed a huge business risk on our company because we could not provide the certificate to continue our country registrations or even participate in tenders. 
    To add more salt to the wounds,  as I try to transfer to another NB, I can't because I can't provide the certificate to complete the transfer.  
    SO unacceptable.
    Original Message


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