Ummm ... immediately? You should review the contract you have with your Notified Body for surrendering a Technical Documentation file - it should be in the contract. If this is not in the contract you should inquire with your individual Notified Body. Most have timelines or indicate in the request when they expect the documentation. Too long and they might wonder or question why it is not available, which could trigger an audit.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Apr-2020 12:49
From: Anonymous Member
Subject: IVDR - Technical File (Notified Body Request)
This message was posted by a user wishing to remain anonymous
Is there a set time limit an organization has to submit an IVDR compliant Technical File to a Notified Body when requested?
Please note: This would pertain to the request originating after an issue or something other than an initial submission for a CE application
Thanks