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CE Mark and PMCF study

#1
hi everyone,
Thank you for accepting me here in what seems to be a sort of paradise for our community.
I will very much appreciate it if you could share your thoughts about the following.
We are having a client going for CE Mark both in the US and under EU-MDR for a class IIb implantable device. They are running a clinical trial and insist that they will be using its follow-up period as the only source for their PMCF plan and will claim this is their PMCF study (for MDR)
Do you think this makes sense for a non CE-marked device, how do you think the NB might react to such a decision?
I have proposed to make a distinction and prepare an ''independent'' PMCF plan but since they do not have their CE yet, am I wrong here?
thks and thks for having me here
 
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#2
Is this clinical trial not in the EU? I think you are saying that they want to compile their PMCF data prior to obtaining the CE Mark. By definition, a PMCF study is one that take place after the device is placed on the EU market. Using post market data from another region will not work because risks and benefit-risk ratio may change because of factors associated with the EU region in which it is used.
 
#3
yes, yes exactly, this is what I am trying to say, which makes no sense to me but I thought maybe I was missing sth in the regulations. But they take it a step further and say that they will take the follow-up results of their trial (which is happening in the EU) and use them for their PMCF plan, i.e. they will include in their PMS plan a statement that their data for the PMCF will be exclusively the data/feedback they will be getting from this trial.
And then all this verbiage will be also used for a FDA approval. Does that make sense? Don't they need to distinguish the (potential) PMCF studies that will be maybe/maybe not needed from the results of a clinical trial that will be used for CE marking?
I am mostly worried about FDA because I think the NB in Europe will reject their thinking anyway.
Any feedback is welcome guys! thks
 
#4
I would suggest that the clue is what PMCF stand for?

Post Marketing Clinical Follow-up

ie follow-up after the CE mark has been obtained. The trial will need to be complete to get the CE mark. And then you have to decide what more has to be done.
 
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