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Navigating the New IGJ Guidance on Post-Market Surveillance

Published in: Uncategorized

Published on: 14 November 2024

What Medical Device Manufacturers Need to Know!

New IGJ Guidelines Emphasize Importance of PMS

On October 8, 2024, the Dutch Health and Youth Care Inspectorate (IGJ) released new guidance urging medical device manufacturers to implement robust Post-Market Surveillance (PMS) systems. This publication underscores the critical role of effective PMS in ensuring patient safety, regulatory compliance, and market competitiveness. For manufacturers, this call-to-action from the IGJ is not just a regulatory requirement—it’s an opportunity to strengthen product quality and safety across the board.

Why Is PMS Important?

Post-Market Surveillance is a regulatory obligation for all medical device manufacturers under the EU Medical Device Regulations (MDR and IVDR). PMS involves systematic activities to monitor and collect data on a device’s performance and safety once it is placed on the market. The aim is to identify potential risks and address them swiftly to protect patient safety.

The recent publication by the IGJ emphasizes that many manufacturers still have room for improvement in their PMS practices. Failing to establish a robust PMS system not only puts patient safety at risk but can also lead to significant regulatory consequences, including product recalls, fines, and loss of market access.

Key Takeaways from the IGJ’s Publication

The IGJ’s publication outlines several key expectations for manufacturers regarding PMS:

Manufacturers should collect the post-market data in a proactive and reactive manner. The proactive data collection includes, but is not limited to, customer feedbacks, user interviews, literature search, medical device registries, and other information released from the regulatory agencies on similar devices. The reactive data collection includes but is not limited to complaints reporting, adverse event reporting, field safety corrective actions and recalls. The IGJ expects companies to implement systems that enable timely data analysis to detect and respond to emerging risks.

PMCF/PMPF is an integral part of the PMS. The PMCF/PMPF data is used to verify the device’s clinical performance and safety under real-world circumstances and to find any possible risks that might not have been noticed during the pre-market clinical/performance evaluation. Manufacturers should plan for PMCF or PMPF based on their gaps, any unanswered questions, or unclarity on long-term clinical performance in clinical/performance evaluation. Literature reviews, post-market studies, real-world clinical evidence, and user surveys are a few types of PMCF/PMPF data sources. If PMCF/PMPF studies are not required, a justification must be provided.

The publication highlights the need for a systematic approach to risk management in PMS. Manufacturers must integrate PMS data into their risk management processes to ensure that their devices remain safe throughout their lifecycle.

The IGJ stresses the importance of transparency in reporting PMS findings to regulatory authorities. Regular updates, including Periodic Safety Update Reports (PSURs) and trend reports, should be submitted in accordance with the MDR and IVDR requirements.

The guidance calls on manufacturers to view PMS as a continuous improvement tool rather than a one-time obligation. By using PMS data to refine product design and manufacturing processes, companies can enhance device performance and customer satisfaction.

What Does This Mean for Manufacturers?

The IGJ’s guidance serves as a reminder that effective PMS is essential for maintaining compliance with the MDR and the IVDR and ensuring long-term market access in the Netherlands and across Europe. To meet these expectations, manufacturers should:

Review and Strengthen PMS Systems: Assess current PMS processes to ensure they align with the IGJ’s expectations. This may involve investing in advanced data analytics tools or hiring specialised personnel to manage PMS activities.
Integrate Feedback Loops: Establish feedback loops between the PMS team, quality assurance, and R&D to ensure that PMS insights lead to tangible improvements in device quality.
Train Staff on PMS Requirements: Regular training is essential to ensure that staff understand the latest regulatory requirements and the importance of accurate data collection and reporting.

Conclusion: A Step Towards Safer, More Reliable Medical Devices

The IGJ’s latest publication on PMS is a clear call for medical device manufacturers to enhance their post-market monitoring efforts. By doing so, companies not only stay compliant but also demonstrate a commitment to patient safety and quality. As the regulatory landscape becomes more stringent, a proactive approach to PMS can serve as a key differentiator in the competitive medical device market.

For more information on the IGJ’s, you can contact our experts at Certification Experts. Certification Experts provide tailored advice, practical guidance, and customised templates to support compliance with regulatory requirements.

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