Post market surveillance (PMCF) clinical investigation

gaiacasini22

Registered
Hi everyone, do you have any experience in PMCF clinical investigation submission? There is an huge difference in case the study includes "procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome" (Art.74 MDR), how could I recognise if I´m in that situation?
Any example could be a big help :)
 
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