PMCF plan to justify that our product not require PMCF study

#1
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.
 
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yodon

Staff member
Super Moderator
#2
This is a tough one, but I don't want to see it orphaned. :) We're all seemingly groping in the dark and stances by Tech File reviewers is somewhat all over the map.

I've had clients take what's in Part 5, make a checklist, and when all answers were 'no' (with justification), the reviewer accepted that a PMCF study was not required. Even if some answers were 'yes,' if there was adequate justification (and it had to be quite detailed), the reviewers agreed a study was not necessary.

I think you only need a Plan if a study is indicated. What we've done is say in the PMS Plan how we go about determining whether a PMCF study is necessary or not (the checklist). And if no study, no report.

Please don't take this as any guarantee! While it's worked a couple of times, like I said, reviewers are being VERY critical these days and getting more and more demanding of data supporting safety and efficacy. But if, truly, a study is NOT indicated, you SHOULD be able to justify not doing one. Just be prepared to back the assertion with good, um, data.
 

Watchcat

Trusted Information Resource
#3
I would disagree with the reviewers who accepted the checklist. I would look to the first sentence in Part 5 as my guide:

"...the decision to conduct PMCF studies must be based on the identification of possible residual risks and/or unclarity on long term clinical performance that may impact the benefit/risk ratio."

The central question is whether the data you already have are adequate to address risks, or whether you need to collect more. (I know, I know...you might be inclined to think that, if your data are not adequate, you shouldn't be getting a CE Mark in the first place. Don't be silly. This would stifle innovation.)

The checklist just gives examples of circumstances in which your data might not be adequate. It does not list all such circumstances, and much more important, no matter what circumstances you find yourself in, it does not tell you how to figure out whether your data are adequate or not.

Lucky for many companies I'm not a reviewer. Meow.
 
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