26 February 2025
Importance of and effective Post Market Surveillance (PMS)
The view of the Dutch Competent Authority (IGJ)
The Health and Youth Care Inspectorate (IGJ) has identified significant deficiencies in post-market surveillance (PMS) among medical device manufacturers in the Netherlands. Inspections in 2023 and 2024 revealed that none of the 13 manufacturers met the PMS requirements set by the MDR and IVDR.
Key issues include inadequate integration of PMS into quality management systems, insufficient documentation, and lack of systematic data collection and analysis.
IGJ urges manufacturers to prioritize PMS, enhance their knowledge, and ensure compliance to improve device safety and performance.
Manufacturers should take the following actions regarding PMS:
- Prioritize PMS: Ensure that PMS is given appropriate attention and integrated into the quality management system (QMS).
- Assign responsibility: Clearly assign responsibility for PMS within the organization.
- Enhance knowledge: Safeguard and enhance knowledge of PMS within the organization, seeking external expertise if necessary.
- Review and update plans: Critically assess and update PMS plans to ensure they meet MDR and IVDR requirements.
- Systematic data collection: Implement proactive and systematic procedures for collecting and analyzing relevant data on the quality, performance, and safety of medical devices.
- Define indicators and thresholds: Establish clear indicators and threshold values to determine when action is needed based on PMS data.
- Use PMS data for improvements: Use the results and conclusions from PMS to make systematic improvements to the medical device and take corrective and/or preventive actions.
- Stay informed: Seek out and use available resources for more information and guidance on PMS, and stay alert to new PMS guidance expected in autumn 2024.
- Evaluate compliance: Independently evaluate whether they meet all MDR and IVDR requirements, recognizing that a lack of knowledge about PMS may indicate insufficient knowledge of other aspects of these regulations.
- Share information: Authorized representatives should actively share this information with manufacturers outside the EU, emphasizing the importance of PMS.
Questions? Get in touch!
If you have any doubts or questions, feel free to contact us at: medical@Kiwa.com