What is Post Market Surveillance (PMS)?
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.
What are the requirements for PMS at MDR?
The Medical Devices Regulation describes one of the general obligations of all manufacturers – collection of clinical and safety data after certification or approval (conformity assessment procedures) and market access.
Monitoring the operation of CE-marked equipment is important for the systematic identification of all risks associated with the use of the product. Some of the hazards are only revealed during use, transport, storage, sterilization or cleaning of medical devices. Only during continuous and systematic PMS can manufacturers ensure that medical devices are effective and safe. It must be taken into account that there are no uncontrolled risks, e.g. defects or safety problems.
What is the deadline for PMS requirements under the MDR?
Post-marketing surveillance, market surveillance and vigilance requirements will apply from the date of application of MDR: 26 May 2021.