PMCF
Under the EU MDR, PMCF is the continuous collection of clinical data on a CE-marked device to update its clinical evaluation. When a manufacturer decides PMCF is not needed, the post-market surveillance plan has to justify that.
Under the EU MDR, PMCF is the continuous collection of clinical data on a CE-marked device to update its clinical evaluation. When a manufacturer decides PMCF is not needed, the post-market surveillance plan has to justify that.