Clinical Investigation and Post Market Clinical Follow Up along with Post Market Surveillance should be planned, established, documented, implemented, maintained and updated for each medical device after it has been commercialized. It should be considered the device type and risk class. The PMS should be integrated in the company’s Quality Management System and should be built together and analyze the data on quality, performance and safety of the device throughout its entire life cycle. It should also be allowed to draw conclusions about this data and be linked into the company’s preventive and corrective action system.
The data and conclusions derived from the PMCF study are used to providing clinical evidence for the clinical evaluation in line with PMS planning.
If the clinical investigation is excepted then, is the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device?