Manufacturers need to pay more attention to continuous monitoring of medical device safety

It is important for medical device manufacturers to continuously monitor the quality and safety of their products. European regulations apply to the implementation of this monitoring, also known as Post-Market Surveillance (PMS). Inspection visits to thirteen manufacturers revealed that the manufacturers do not comply with these or do not comply sufficiently. Most manufacturers seem to give too little priority to PMS. The inspectorate is calling on manufacturers to change this. This is about patient safety, but also about the improvement and further development of medical devices.

Medical devices include diagnostic tests, medical software, IV poles or treatment tables. PMS consists of activities a manufacturer must perform to monitor the performance and safety of the device. Examples include conducting (user) research on the product and analyzing incidents and complaints. Importantly, manufacturers continually assess whether the benefits of their product outweigh the risks. If necessary, they should make adjustments or take improvement measures. Regular reporting of PMS results is also mandatory. This applies from the moment a product is put on the market. The purpose of PMS is that the manufacturer always has the correct information about the medical device and thus improves its safe use.

In 2023 and 2024, the inspection visited thirteen manufacturers of various medical devices, software applications and in vitro diagnostics (devices used to test human body material, such as a pregnancy test). None of them fully complied with European requirements for PMS. Among other things, the IGJ often saw that a PMS plan was missing, knowledge was limited or the PMS was not tailored to the medical device in question. The manufacturers themselves often indicated that they found the regulations complex. The IGJ asked the manufacturers to resolve the shortcomings.

Following these inspections, the IGJ urges all medical device manufacturers to implement and prioritize PMS. One way of doing this is by placing the responsibility for PMS unambiguously within the organization and making it part of the entire quality system. In the coming period, the IGJ will continue to visit medical device manufacturers to check whether they meet the PMS requirements. In addition, the IGJ will continue to call attention to the importance of quality and safety control both nationally and internationally.