Post Market Surveillance Process

#1
Hello,

We are going to be seeking CE marking next year. I am working on writing up a post-market surveillance process.
If I understand correctly this includes:
1. Post Market Surveillance SOP
2. Post Market Surveillance Plan (per product)
3. Post Market Surveillance Report

Am I missing anything?

I've seen some examples of the documents above posted here but was wondering if anyone had a really nice example of a PMS SOP they would be willing to share?

Thank you!
 
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Raisin picker

Quite Involved in Discussions
#2
Regarding 3: Yes and no. Depending on device class, you do need a PSUR and/or a PMS report. For class I devices, a PMS report is required, for the other classes, a PSUR is required (per MDR). For class II and III, a PMS report is not explicitly required, but you still need to document all the PMS activities that you defined in your detailed PMS plan (MDR Annex III).
So, add to your list :
4. PSUR (Class II and III)
5. PMCF Plan (or an acceptable justification that no PMCF* is required)
6. PMCF report (see above)

*PMCF studies are only one (possible) part of PMCF activities
 

Raisin picker

Quite Involved in Discussions
#4
I don't know about a PMS template. But for PSUR, which is basically the PMS report for higher class devices, there is a MDCG document to be released soon.
And I think that you will find a lot on PMS here already.
 
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