PMCF

The post-market clinical follow-up (PMCF) is a continuous process for updating the clinical evaluation report and that shall be one of the outcomes of the manufacturer’s post-market surveillance (PMS) plan. A PMCF plan shall specify proactive methods and procedures for collecting and evaluating new clinical data from the use of a medical device once placed on the market or put into service within its intended purpose. According to the requirements for developing a PMCF Plan defined in Annex XIV of Regulation (EU) 2017/745, Cebis implement a PMCF taking into consideration the device itself and the existing clinical evidence with literature search, case reports, survey or clinical investigation.