Call to medical device manufacturers: implement an effective PMS system
The Health and Youth Care Inspectorate (IGJ) supervises post-market surveillance (PMS) at manufacturers of (in-vitro diagnostic) medical devices based in the Netherlands. None of the 13 manufacturers visited by the IGJ in 2023 and 2024 met the PMS requirements.
Opportunities for manufacturers
Only with a well-functioning PMS system can manufacturers detect potential issues with their medical devices at an early stage. These issues can then be addressed before any harm occurs. Furthermore, data from a robust PMS system can lead to improvements to the medical device, offering opportunities for manufacturers.