We all want medical devices to be safe and efficient. Therefore, every medical device put on the market has to undergo strict testing, verification, validation, and evaluation. However, some risks and safety issues only become apparent when the medical devices are in practical use. And this is where Post-Market Surveillance comes into play. 

EU Regulation  2017/746 (IVDR) defines Post-Market Surveillance as: “All activities carried out by the manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.”

The aim of the Post-Market Surveillance process is to actively and systematically gather, record, and analyse relevant data on the quality, performance, and safety of a device throughout its entire lifetime. This allows manufacturers to continuously update the risk-benefit assessment and initiate necessary measures without delay. Manufacturers must collect and assess all information about their medical devices and similar devices from competitors [1].

We at SBAS closely monitor our devices on the market, which allows us to identify any hazards and manufacturing problems early. Post-Market Surveillance helps us to assure high product quality, which means that our customers get a product that is safe and that functions as it is intended to.

[1] https://decomplix.com/post-market-surveillance-pms/#