Hi all,
I am new to the field.
We have a class IIa product, and we have some questions when drafting a PMCF (post-market clinical follow-up study for CE Marking) plan and report.
We would like to justify that our product not require to have PMCF study.
Do the items listed on MEDDEV 2.12/2 rev2, "Part 5. Circumstances where a PMCF study is indicated" already enough to justify?
What's more information that we can stuff in to the plan and report?
Shall we also add literature search (which same with in CER) into our PMCF plan and report?
Please kindly advise, Thank you.
I am new to the field.
We have a class IIa product, and we have some questions when drafting a PMCF (post-market clinical follow-up study for CE Marking) plan and report.
We would like to justify that our product not require to have PMCF study.
Do the items listed on MEDDEV 2.12/2 rev2, "Part 5. Circumstances where a PMCF study is indicated" already enough to justify?
What's more information that we can stuff in to the plan and report?
Shall we also add literature search (which same with in CER) into our PMCF plan and report?
Please kindly advise, Thank you.