Regular updates of clinical evaluation report

#1
A regular update of the clinical evaluation report is required after having marketed the device so it means we update the 'state-of-the-art' and the literature review.
Are those activities part of the PMCF next to any other specific post-market clinical activities?
Any view on this would be very welcome
thank you
 
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primavesvera

Involved In Discussions
#3
Along this line, I also have an additional question.

If you perform PMCF and one of it is a clinical study, you would need to update the CER, correct?
Do you need to inform your Notified Body each time when there is a change (even adding a PMCF report) since the CER is part of the technical documentation?

Thanks in advance.
 
#4
We had a pretty good discussion (I thought) on postmarket activities. I'm not completely sure what you mean by 'next to' but there are certainly overlaps in these activities.
thank you Yodon, for your help and pointing out the related very relevant discussion and great overview. For our yearly update of the CER we do a global literature review of the clinical outcomes and side-effects published using our system. I was wondering if this is considered part of the post-market clinical follow-up?
 

Philip B

Quite Involved in Discussions
#5
Not sure but I don't think so. Annual update of the clinical evaluation report is a desk based activity, like you, we do a literature search and update the sales vs complaints data. PMCF is more of a field based ongoing clinical investigation (I think - there is a lot of debate around this here on the Cove!) but the findings of the PMCF will of course feed into your clinical evaluation. As with everything I suspect there will be more scrutiny of higher risk devices in this regard.
 

Steve M

Starting to get Involved
#6
We do the same as you Philip regarding the CER. The PMCF plan includes a more regular review of the literature and complaints to spot trends and emerging risks. The CER would be updated sooner than the regular scheduled update if anything was spotted that would potentially affect the benefit-risk ratio. Is this understanding of the process correct?
 
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