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Description: With the implementation of the MDR more and more emphasis falls on the planned PMCF activities. In this solutions circle, I would like to debate the difference between general and specific PMCF activities. The topic is especially relevant with the more widespread use of surveys as a method to fulfill the PMCF requirements of Annex XIV.
The questions that could be discussed are:
Should surveys be considered a general or specific PMCF activity?
Should surveys be called PMCF studies?
If a survey discusses sample size and statistical calculation, should this be called clinical investigation? What is the difference between surveys, PMCF studies, and clinical investigations?
By the end of the session, I hope that we could have a similar enough understanding of the terminology related to the PMCF activities.
Learning Objectives:
At the end of the solution circle, the participants to have common understanding related to the terminology used to describe the PMCF activities.
The participants are able to identify the difference between general and specific PMCF activities.