Article 2 of the MDR defines post-market surveillance as all activities carried out by manufacturers in cooperation with other economic operators to establish and update systematic procedures for the proactive collection and review of experience gained from devices they place on the market, make available on the market or put into service, which are carried out in order to identify the need for any necessary corrective or preventive action immediately" . Incident reporting and surveillance of medical devices identifies problems with the design, manufacture, final inspection or use of medical devices and increases patient safety.
The purpose of the post-market surveillance system is to systematically and proactively collect, record and analyse data which are important for the quality, performance and safety of the appliance throughout its shelf-life and to update the risk-benefit assessment. Manufacturers shall be obliged to collect, assess any type of information about their competitors' medical devices and related devices.