Importance of and effective Post Market Surveillance (PMS)

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. ​ 

Read full document here: Call to medical device manufacturers: implement an effective PMS system | Publication | Health and Youth Care Inspectorate