Insights from IGJ and Swissmedic Report
In the medical device industry, maintaining product safety and performance long after market introduction is crucial. Post-market surveillance (PMS) plays a pivotal role in ensuring devices continue to meet regulatory standards, particularly under the MDR, which also forms the foundation for the PMS requirements set out in the Medical Devices Ordinance (MedDO). However, implementing effective PMS systems presents significant challenges for many manufacturers.
Dutch Health and Youth Care Inspectorate (IGJ)
According to a recent report by the IGJ, several areas of concern were identified during inspections in 2023 and 2024:
- Incomplete Implementation of PMS Plans: Manufacturers collect data but often in an unstructured manner. PMS plans lack clarity on what information is intended to be gathered, how data is gathered from the selected sources, and how it should be analyzed, making the process heavily dependent on individual interpretation.
- Limited Knowledge and Misconceptions about PMS: Many manufacturers confuse PMS with vigilance activities, focusing on incident management rather than proactive trend analysis. Additionally, PMS is not recognized as an integrated system connected to risk management and clinical or performance evaluation.
- PMS Systems Not Tailored to Device Types: Generic PMS plans are applied across different device types, leading to vague data collection and analysis methods. Without customized approaches, manufacturers risk missing critical safety and quality insights.
- Unclear Action Triggers: PMS plans lack predefined indicators or thresholds to initiate actions like design changes or updates to risk management. This can delay necessary interventions, compromising device safety.
These findings highlight the complexity of MDR compliance and underscore the need for manufacturers to proactively enhance their PMS systems. By addressing these challenges, the industry can improve device safety, foster innovation, and maintain regulatory compliance.
Swissmedic’s Focus Campaign
Swissmedic’s recent focus campaign further underscores the challenges manufacturers face in effectively implementing PMS requirements. A review of 30 legacy medical devices (risk class IIa and higher), of which 28 were from foreign manufacturers, found non-conformities in 20 cases, with a total of 85 PMS-related issues.
Key findings are:
- 11 products had no PMS plan or a plan that failed to meet regulatory requirements.
- 8 products had safety reports that were not prepared in accordance with the PMS plan.
- 9 products contained incomplete or missing information in the safety report, which is required for the entire device lifetime.
Swissmedic will oversee corrective actions and may impose further measures to ensure compliance.
Risk for Legacy Devices
Many manufacturers continue to market legacy devices that have moved to higher risk classifications under MDR, requiring certification by a notified body. The IGJ found inadequate PMS systems among most of these manufacturers, suggesting a broader compliance issue within the industry.
Without robust PMS practices, manufacturers risk delays in obtaining CE certification, potentially halting market access for these devices. This emphasizes the importance of effective PMS systems to avoid disruptions in the supply chain.
Key Action Points for Manufacturers
- Assign Clear Responsibilities: Define PMS roles within your organization and integrate them into the QMS.
- Safeguard and Enhance PMS Knowledge: Ensure in-house expertise or seek external support as needed.
- Utilize Available Resources: Leverage the PMS assessment framework, relevant legislation, and upcoming European guidelines for comprehensive guidance.
- Apply PMS to All Devices: Make sure that all marketed devices, including legacy products, comply with current PMS requirements.
- Self-Assess Compliance: Continuously evaluate adherence to MDR requirements, acknowledging that gaps in PMS may indicate broader regulatory issues.
Need Support with Your PMS Strategy?
Navigating MDR’s PMS requirements can be challenging, but expert help is just a call away. At MedQR Consulting, we specialize in QA and RA services tailored to the medical device industry. Our expertise helps manufacturers design and implement effective PMS systems, ensuring compliance while enhancing product safety and performance.
Need support with your PMS strategy? Contact MedQR Consulting today, and we’ll help you stay ahead of regulatory changes.
