IMDRF guide on Post Market Clinical Follow-up Studies (PMCF)
PMCF is a continuous process that updates the manufacturers’ clinical evaluation during the Post-market surveillance. They must collect user feedback, clinical data, and all other clinical experiences. This article provides an overview of the design, implementation, and appropriate use of PMCF studies. these are an integral part of PMS reports. There may be some data limitations during the premarket phase, like the duration of the investigation and the number of subjects involved or restri...
