The Medical Device Regulation 2017/746 (MDR) defines PMS as:
All activities carried out by manufacturers in cooperation with other economic operators to institute and maintain a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market, or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.
All conformity assessment standards, including ISO 13485:2016, now require manufacturers to maintain a PMS system regardless of how their medical device is classified.