Dutch Regulators on Post-Market Surveillance Compliance Issues

The Dutch Health and Youth Care Inspectorate (IGJ) recently conducted inspections of 13 medical device manufacturers based in the Netherlands and found that none fully complied with the Post-Market Surveillance (PMS) requirements outlined in the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This has prompted the IGJ to issue a call to action for all manufacturers, emphasizing the critical importance of a well-functioning PMS system for ensuring the safety and effectiveness of medical devices and urging manufacturers to address deficiencies. Belo summarizes the key findings of the IGJ report, areas of concern, manufacturer perspectives, IGJ expectations, and key action points. It also includes regulatory context and global developments related to PMS.

Key Themes and Findings:

• Widespread Non-Compliance: The most significant finding is that all 13 manufacturers inspected failed to fully meet the PMS requirements of the MDR and IVDR. This indicates a systemic issue within the sector. "None of the 13 manufacturers visited by the IGJ in 2023 and 2024 met the PMS requirements as laid out by the MDR and IVDR."
• Areas of Concern Identified by the IGJ:
  • Poorly Developed PMS Plans: PMS plans are often not well-developed, lack specific details, and are not tailored to the specific medical device. "PMS is partially implemented, but the plan is not well-developed." Plans often fail to specify which information should be collected, how it will be gathered, or how it will be analyzed.
  • Limited Knowledge of PMS: Manufacturers often equate PMS with vigilance requirements and lack a clear understanding of the purpose and implementation of PMS. "Manufacturers have limited knowledge, skills and focus regarding the purpose of PMS." Many also don't understand how PMS interacts with other systems like risk management and clinical/performance evaluation.
  • Generic PMS Systems: PMS plans are often not customized for the specific type of medical device, leading to a lack of clarity regarding which information is relevant to collect and how it should be analyzed. "The PMS system is not tailored to the specific type of medical device"
  • Lack of Action Thresholds: Manufacturers lack a clear understanding of when action is needed based on PMS data, specifically regarding indicators and threshold values. "Manufacturers lack a clear understanding of when action is needed based on PMS" This means they may not address critical information in a timely manner

• Manufacturers' Perspectives:
  • Complexity of Requirements: Manufacturers find the new PMS requirements in the MDR and IVDR complex and resource-intensive. "Manufacturers find the new PMS requirements in the MDR and IVDR to be complex, requiring significant effort to comply."
  • Cost and Time Constraints: Cost and time are significant factors, particularly for smaller manufacturers.
  • Lack of Experience: Manufacturers that market devices not requiring notified body assessments often lack experience with PMS processes.
• IGJ Expectations:
  • Prioritize PMS: IGJ expects manufacturers to prioritize PMS and ensure sufficient knowledge within their organizations.
  • Address Issues Promptly: To detect and address potential issues early on to prevent harm.
  • Recognize Opportunities: By implementing an effective PMS, manufacturers can innovate and improve their medical devices, potentially becoming leaders in the field.
• IGJ Key Action Points for Manufacturers:
  • Review Publication: Critically assess whether they meet PMS requirements. "All manufacturers, including those not inspected, should carefully review this publication and critically assess whether they meet the PMS requirements."
  • Assign Responsibility: Clearly assign responsibility for PMS within the organization and integrate it into the QMS.
  • Safeguard Knowledge: Ensure knowledge of PMS is maintained and seek external expertise if needed.
  • Use Available Resources: Utilize resources such as the IGJ PMS assessment framework and relevant legislation.
• Supervision and Specific Findings Breakdown: The IGJ also broke down their findings based on specific elements of the assessment framework:
  • Quality Management System (QMS): Most manufacturers integrated PMS into their QMS.
  • Required Documentation: Slightly over half of the manufacturers had a PMS plan. The content of PMS reports was often insufficient, lacking summaries of results and conclusions.
  • Frequency: Only some manufacturers updated the PMS report/PSUR when necessary.
  • Data: Despite regulations, manufacturers didn't always include all required data sources in their PMS plans. More than half lacked a clear procedure for proactively and systematically obtaining PMS information.
  • Analysis: Only a few PMS plans described indicators/thresholds for adjustments, resulting in unclear evidence for further action based on critical safety/quality information.
  • Results and Conclusions: Half of the manufacturers' PMS reports/PSURs did not contain conclusions about a renewed benefit-risk analysis.
  • Execution: Not all manufacturers followed the procedure for updating clinical/performance evaluations based on PMS results.
• Regulatory Context: The MDR and IVDR have placed increased emphasis on PMS, and regulatory bodies like the IGJ are actively enforcing these requirements. The U.S. FDA has also adopted a "holistic" perspective (Total Product Life Cycle - TPLC) throughout the entire lifecycle of a device.
• Global Efforts in PMS: ISO released ISO/TR 20416:2020 on PMS as a guide to assist manufacturers. Swissmedic has also requested manufacturers' PMS documents, even when a Notified Body is involved.

Implications:

The IGJ's findings have significant implications for medical device manufacturers operating in or marketing to the EU:

• Increased Regulatory Scrutiny: Manufacturers can expect increased scrutiny from regulatory bodies regarding their PMS systems.
• Enforcement Actions: Non-compliance can lead to enforcement actions, including requirements to resolve violations.
• Potential Market Access Issues: Failure to meet PMS requirements could delay certification by notified bodies and potentially disrupt market access.
• Reputational Risk: Non-compliance can damage a manufacturer's reputation and erode trust with healthcare professionals and patients.

Recommendations:

• Manufacturers should immediately conduct a thorough review of their PMS systems against the MDR and IVDR requirements.
• Manufacturers should address any identified gaps or deficiencies in their PMS plans, processes, and documentation.
• Manufacturers should invest in training and resources to ensure that personnel have the necessary knowledge and expertise to effectively implement PMS.
• Manufacturers should collaborate with notified bodies and other stakeholders to ensure compliance and best practices.

Conclusion:

The IGJ's findings highlight the critical need for medical device manufacturers to prioritize and strengthen their PMS systems. A well-functioning PMS system is essential for ensuring the safety and effectiveness of medical devices, meeting regulatory requirements, and maintaining market access. Proactive steps are needed to address the identified issues and foster a culture of continuous improvement in PMS practices. As stated in the report, 'The IGJ expects all manufacturers to prioritise PMS and ensure that there is sufficient knowledge of PMS within their organisation. Only with a well-functioning PMS system can manufacturers detect potential issues with their medical devices at an early stage.'

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