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  • 1.  Escalating CE Certificate Renewal issues within BSI

    This message was posted by a user wishing to remain anonymous
    Posted 07-Nov-2018 15:45
    This message was posted by a user wishing to remain anonymous

    Dear RAPS community,

    I have run into an issue with the renewal of my company's CE Certificate.  Our Notified Body is BSI,  recently completed a technical documentation audit in which a major non-conformance was observed.  The good news is that the non-conformance has been closed.  The bad news is that the audit took place so close to the expiration date of the CE Certificate renewal that it has now impacted the renewal of the certificate and has caused a gap.  Since the non-conformance is now closed I want to to escalate the issue within BSI and bring urgency to the renewal process for the issuance of the new certificate.  All of the notified bodies seem very overwhelmed and these processes seem to take longer than expected.  Is there any advice or experience on how to best escalate the issue within BSI?  I am already working closely with the scheme manager.

    Thank you in advance for any guidance or insights you may have to offer.


  • 2.  RE: Escalating CE Certificate Renewal issues within BSI

    Posted 07-Nov-2018 16:16
    Edited by Phani Puppala 07-Nov-2018 16:16
    Since you addressed the audit nonconformances, you could request the certification/ scheme manager to issue an interim certificate while your renewal certificate is being processed. This helps you to continue selling your product in EU and other countries without interruption.

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    Phani Puppala
    Franklin MA
    United States
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    Original Message


  • 3.  RE: Escalating CE Certificate Renewal issues within BSI

    Posted 09-Nov-2018 09:26
    If there is support I can offer, please reach out to me directly as I've posted before on this forum (bill.enos@bsigroup.com).  There are many factors that must come together for a certificate to be properly reissued and specific cases can vary.  


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    Bill Enos
    Senior Commercial Operations Director
    Regulatory Services (Medical Devices) - Americas
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    Original Message


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