The medical device industry is now witnessing prompt navigation towards the MDR transition and this global legislative shift particularly emphasizes post-market clinical follow-up (PMCF) requirements under the post-market surveillance (PMS) obligations. Besides acquiring CE marking, the manufacturer must also continue to monitor the performance and safety of the device throughout its expected lifetime. The PMCF is a continuous process and this activity involves a proactive collection of pertinent clinical data on the performance and safety of the device. Most of the manufacturers feel overwhelmed to strategize the approach for PMCF activities and ensure that the strategy can accommodate all the legislative requirements.
This Whitepaper entitled “Post-market clinical follow-up (PMCF) overview” will articulate the high-level approach for PMCF activities including details on the impact of the clinical data gained through such PMCF activities for any class of medical devices. Download the whitepaper to continue reading.