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This message was posted by a user wishing to remain anonymous

Our EN ISO 13485 certificate has just expired.  Our Notified Body performed a recertification audit last summer and the auditor recommended us for recertification.  The Notified Body sent a draft certificate for my review and approval last December.  Unfortunately the Notified Body says that the file is still under review by the certification body and that they can not provide documentation which bridges the gap between expiration of the old certificate and issuance of the new certificate.  This Notified Body has always come down to the wire when issuing certificates, so I'm guessing that they are now backlogged due to Covid and MDR.  Are others having similar experience with Notified Bodies?

Hello Anon,

Thank you for sharing this information, absolutely needs to be risen to a much greater awareness.  Have you considered contacting the Accreditation Body/National Authority who is responsible for your Notified Body advising of the situation?  If enough companies contacted Accreditation Bodies or National Authorities of these Notified Bodies and certification bodies, something might actually change and those entities being held to account.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Emergo Group Inc
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Original Message:
Sent: 21-Apr-2021 09:46
From: Anonymous Member
Subject: Expired EN ISO 13485 certificate

This message was posted by a user wishing to remain anonymous

Our EN ISO 13485 certificate has just expired.  Our Notified Body performed a recertification audit last summer and the auditor recommended us for recertification.  The Notified Body sent a draft certificate for my review and approval last December.  Unfortunately the Notified Body says that the file is still under review by the certification body and that they can not provide documentation which bridges the gap between expiration of the old certificate and issuance of the new certificate.  This Notified Body has always come down to the wire when issuing certificates, so I'm guessing that they are now backlogged due to Covid and MDR.  Are others having similar experience with Notified Bodies?

This message was posted by a user wishing to remain anonymous

I would make a complaint to your notified body.

I've found (including recently) 2-3 months for a recertification certificate after recomendation from our NB as it has to go to an internal panel first but the timelines you mention I wouldn't be happy about.
Original Message:
Sent: 21-Apr-2021 09:46
From: Anonymous Member
Subject: Expired EN ISO 13485 certificate

This message was posted by a user wishing to remain anonymous

Our EN ISO 13485 certificate has just expired.  Our Notified Body performed a recertification audit last summer and the auditor recommended us for recertification.  The Notified Body sent a draft certificate for my review and approval last December.  Unfortunately the Notified Body says that the file is still under review by the certification body and that they can not provide documentation which bridges the gap between expiration of the old certificate and issuance of the new certificate.  This Notified Body has always come down to the wire when issuing certificates, so I'm guessing that they are now backlogged due to Covid and MDR.  Are others having similar experience with Notified Bodies?