2024-10
Original communication:
Manufacturers should pay more attention to the continuous monitoring of the safety of medical devices
It is important that medical device manufacturers continuously monitor the quality and safety of their products. European regulations apply to the implementation of this surveillance, also called Post-Market Surveillance (PMS). The Dutch inspection (IGJ) visits to 13 manufacturers showed that manufacturers do not comply with this or do not comply sufficiently. Most manufacturers seem to give too little priority to PMS. The inspectorate calls on manufacturers to change this. It is about patient safety, but also about the improvement and further development of medical devices.
Post-Market Surveillance contributes to the safe use of medical devices
Medical devices include diagnostic tests, medical software, IV poles or treatment tables. PMS consists of activities that a manufacturer must perform to monitor the performance and safety of the device. Examples include conducting (user) research into the product and analyzing incidents and complaints.
It is important that manufacturers continually assess whether the benefits of their product outweigh the risks. If necessary, they must make adjustments or improvement measures. Regular reporting of PMS results is also mandatory. This applies from the moment a product is placed 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.
None of the 13 manufacturers met the PMS requirements
In 2023 and 2024, the Dutch inspectorate visited 13 manufacturers of various medical devices, software applications and in-vitro diagnostics (tools for testing human body material, such as a pregnancy test). None of the 13 fully met the European requirements for PMS. The IGJ often saw, among other things, that a PMS plan is missing, knowledge is limited or that the PMS is not focused on the medical device in question. The manufacturers themselves often indicate that they find the regulations complex. The IGJ has asked the manufacturers to resolve the shortcomings.
IGJ call to manufacturers: work on PMS
Following these inspections, the IGJ encourages all manufacturers of medical devices to implement PMS and to give it priority. This can be done, among other things, by clearly assigning responsibility for PMS within the organization and making it part of the entire quality system.
In the coming period, the IGJ will continue to visit manufacturers of medical devices to check whether they meet the PMS requirements. In addition, the IGJ continues to draw attention to the importance of quality and safety control at both national and international levels.
The publication can be downloaded in our library
Source: Call to medical device manufacturers: implement an effective PMS system | Publication | Health and Youth Care Inspectorate (igj.nl)
