Yes, would suggest contacting the Notified Body directly, there all have different processes if changes need to made during an application currently in review.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 05-Jan-2023 21:11
From: Jinali Bhavsar
Subject: Mechanism to amend IVDR Technical Documentation submitted to NB?
Hello Anon,
I haven't come across anything so would suggest to contact your scheme manager or reviewer. There is a Change notification process in place for making updates after NB approval of TF.
BR,
Jinali
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Jinali Bhavsar RAC
Sr Regulatory Affairs Specialist II
San Jose CA
United States
Original Message:
Sent: 05-Jan-2023 14:42
From: Anonymous Member
Subject: Mechanism to amend IVDR Technical Documentation submitted to NB?
This message was posted by a user wishing to remain anonymous
FDA premarket submissions can be revised while being reviewed by FDA by submitting an amendment to the original submission. Is there a similar process in place under MDR/IVDR to update or revise the Technical Documentation while it is being reviewed by a Notified Body?
Thank you