IGJ Report Urges Medical Device Manufacturers to Prioritize PMS

The IGJ, or the National Competent Authority of the Netherlands, published a report as a call to manufacturers to focus on PMS.

As highlighted by the IGJ Post-Market Surveillance (PMS) is crucial for ensuring the quality and safety of medical devices. European regulations mandate that manufacturers implement PMS to monitor the performance and safety of their products. This involves activities such as conducting user research, analyzing incidents and complaints, and regularly reporting PMS results. The goal is to ensure that the benefits of the devices outweigh the risks and to make necessary adjustments for improvement.

What are the keypoints in the IGJ report for PMS?

• • Inspection Findings:
    • In 2023 and 2024, inspections of 13 manufacturers revealed that none fully complied with European PMS requirements. Common issues included the absence of a PMS plan, limited knowledge, and PMS activities not tailored to specific devices. Manufacturers often cited the complexity of regulations as a challenge.
  • IGJ’s Call to Action:
    • The Dutch Health and Youth Care Inspectorate (IGJ) has urged manufacturers to prioritize PMS by integrating it into their quality systems and clearly assigning responsibility within their organizations. The IGJ will continue to monitor compliance and emphasize the importance of PMS for patient safety and the advancement of medical devices.
  • Conclusion:
    • Continuous monitoring through PMS is essential for the safe use and development of medical devices. Manufacturers must address the identified shortcomings to comply with regulations and ensure patient safety. The IGJ’s ongoing inspections and advocacy highlight the critical role of PMS in maintaining high standards in the medical device industry.

The full report is available in Dutch here.

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