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IGJ Report Emphasises the Importance of PMS
The Dutch 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.
For manufacturers, it is essential to have a well-functioning PMS system in place to promptly detect and resolve any potential issues. This minimises the risk of injury for users of the medical devices. Furthermore, data from a robust PMS system can lead to improvements to the medical device, offering opportunities for manufacturers
What are the top takeaways from the IGJ PMS report?
Inspection Findings:
The implementation of PMS was found to be inadequate at all 13 manufacturers visited in 2023 and 2024. There was little to no difference in the number and type of non-compliances between the various categories of medical devices inspected. Manufacturers perceive the PMS requirements from the MDR and IVDR to be complex.
What the IGJ says:
The IGJ has urged manufacturers to prioritise PMS. They can do this by integrating it into their quality systems and clearly assigning responsibility within their organisations.
As well as that, the IGJ will continue to monitor compliance and emphasise the importance of PMS for patient safety.
The next steps
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