Post Market Surveillance SOP - Word Version

#21
I have had a request to supply a Word version of the PMS SOP (previously pdf format) I attached to a previous post - so here it is!

Steve
Hi Steve,

Thanks for your PMS SOP. our auditor is asking about the pms report.
if you have any idea what should be put in in this report and if you have some similar document can you plz share?

Sarah
 
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SteveK

#22
Hi Sarah,

I do not create a report as such. The data is captured in a quarterly complaints review, updated Clinical Evaluation and Risk Management Files. I also have an on-going alert/recall database of products similar to ours from about 17 CAs e.g. MHRA, FDA, TGA etc., information from which is used in File updates as appropriate.

Steve
 
#23
Hi Steve,

thanks for your answer. actually I have almost the same things as you but I did not place them in a combined/central place, I think I need to prepare a summary document to state how we capture data from different sources and the conclusion from each section need to be clearly stated.

Sarah
 

nozzle

Starting to get Involved
#24
Hi Steve,

thanks for your answer. actually I have almost the same things as you but I did not place them in a combined/central place, I think I need to prepare a summary document to state how we capture data from different sources and the conclusion from each section need to be clearly stated.

Sarah
Hi Sarah,
I was asked about our PMS report during an audit by our notified body this week. Would be interested in seeing your document if possible.
 
#25
Hi nozzle,
Sorry for the late response. actually I did not prepare sth new, but have a summarize document to collect ALL the info on a yearly basis. here below i extract the content of my doc,
1.purpose and scope
2.analysis of PMS data
2.1. complaints handling
2.2. literature review
2.3. sales feedback
2.4. conferences feedback
2.5. incident mgmt
2.6. risk management
2.7. PMCF
2.8. clinical evaluation
...
I thought what the auditor wants to see is we do the analysis on PMS. just my understanding, hope it can be helpful for you.
Sarah
 

nozzle

Starting to get Involved
#26
Thanks for the reply Sarah. :agree1:

Would anyone be kind enough to sanity check this for me please. For PMS purposes can I classify products by intended use as long as they're the same class. For example could I produce one PMS report for single use and reusable devices?
 
#28
Hi All,

We are manufacturers of surgical gloves based in India. We export to big distributors in Europe, who in turn supply to the end users in hospitals.

Since we do not supply gloves directly to the end user, we have no information on the usage pattern, the usability information or direct interaction on customer complaint. We usually get a feedback form from the distributors which usually has not much information on the actual usage.

Our notified body insists that we get some more detailed information from the end user. How do we get to that? Moreover, most of the customers have an OBL agreement with us and we supply in their CE number.

Could anyone kindly suggest an explanation to this dilemma? Is there any solution for this situation in the directive?

Thank you, in advance.

jose paul meleth
 

JoshuaFroud

Involved In Discussions
#29
Hi Steve


Thanks for posting this, can I ask what standards this procedure was written to comply to? I've been having a read and I certainly think there are some areas I can improve my own on based on this.
 

Wolf.K

Quite Involved in Discussions
#30
Our notified body insists that we get some more detailed information from the end user. How do we get to that? Moreover, most of the customers have an OBL agreement with us and we supply in their CE number.

This is from the EMERGO homepage; so probably you will have to change the contracts with your customers, if OBL does not work anymore. We are manufacturerer and do not sell to OBL. But we have contracts with our distributors that they are required to hand feedback back to us. That does not work that well, but well enough for our notified body...


5) What will the MDR mean for own-brand labeling (OBL) of some devices?

"Every manufacturer must have access to full technical documentation according to the MDR. This would require that OBL manufacturers hand over those files, which may not be easily done. It is expected that in practice this requirement will put an end to OBL manufacturing as we know it under the MDD."
 
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