Understanding PMS (Post Market Surveillance) and PMCF (Vigilance and PMCF)

S

sance

#1
Hello all,

I little background before I ask question: My company had PMS procedure in place (by the way I want to thank to forum memebers for their great input in my learning curve that resulted in a great procedure). Our products are very simple (dressings). There was no MDR report ever. Last year (2013) we performed literature search (comparison between our products and other competitors products). Through annual management review all complaints, CAPAs, internal audits, risk management of each product, etc. were reviewed. I have compiled all of that clinical literature data in the clinical evaluation report. Our auditor was satisfied with procedure and suggested to add also adverse events or trade shows reports etc. However, this year I am a little bit confused.

Do we have to do PMCF (Post-Market Clinical Follow-up) now? Is PMCF done only for compiling clinical studies of the human subjects (in hospitals or clinics) or does it include literature search? As I'm reading guidelines and regulations, my understanding is that we for sure have to have PMS in place and based on the results of the PMS (for example new hazard is identified) then we have to do PMCF. Please correct me if I am wrong. Any help will be greatly appreciated. Thank you all in advance!:confused:
 
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