In your PSUR just put not applicable, and point back to your PMCF checklist created to justify not performing a PMCF (the output of the PMCF checklist should be a controlled, referenced document in your PMS that you can reference).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-May-2019 12:54
From: Anonymous Member
Subject: PSUR/ PMCF requirement
This message was posted by a user wishing to remain anonymous
Hello Everyone,
All our current products do not require a PMCF, so we are just creating a PMCF checklist to justify it.
One of the PSUR requirements is to report the main findings of the PMCF. If we don't need PMCF for our device then how do we add it's main findings? and if our product doesn't require that then how do we justify that part?
Please advise. Thanks!