Post-Market Surveillance (PMS): A Key Pillar for Compliance and Innovation in the Medical Device Industry
In the rapidly evolving field of medical devices, compliance with Post-Market Surveillance (PMS) requirements has become a cornerstone of safety, innovation, and market competitiveness.
However, a recent report by the Health and Youth Care Inspectorate (IGJ) paints a concerning picture: none of the 13 manufacturers inspected in 2023 and 2024 fully met the PMS requirements outlined in the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
This finding underscores the critical need for manufacturers to prioritize PMS systems as both a regulatory mandate and a strategic asset.
What is Post-Market Surveillance (PMS)?
PMS is a continuous process that starts when a medical device enters the market and persists throughout its lifecycle. It involves systematically monitoring the performance and safety of devices, collecting and analyzing data, and implementing corrective or preventive measures when necessary.
Under the MDR/IVDR, PMS requirements are more stringent than ever. They demand manufacturers integrate PMS into their Quality Management Systems (QMS), tailor it to specific devices, and proactively address safety and performance trends.
Consequences of Non-Compliance
The IGJ’s inspections revealed widespread shortcomings in PMS implementation, including poorly defined plans, inadequate data collection, and insufficient analysis. These gaps have significant implications:
- Patient Safety Risks: A lack of effective PMS delays the detection of safety issues, potentially leading to incidents that could harm users.
- Delays in CE Certification: Non-compliant devices risk delays in certification, especially for “legacy devices” transitioning to higher risk categories under MDR/IVDR. This disrupts market access and revenue.
- Regulatory Penalties: Authorities may impose enforcement actions, requiring manufacturers to address violations before resuming operations.
- Lost Market Opportunities: Failing to leverage PMS insights to improve devices can leave manufacturers behind in a competitive industry.
The Strategic Advantage of PMS
While the risks of non-compliance are high, PMS also offers unique opportunities. A well-implemented PMS system can:
- Enhance Product Safety: Early identification of risks allows for timely corrections, preventing incidents before they occur.
- Drive Innovation: Data collected through PMS can reveal trends that lead to design improvements or entirely new product features.
- Build Market Trust: Demonstrating a commitment to safety and quality reinforces confidence among users and regulators alike.
Key Steps for Manufacturers
To address the challenges and reap the benefits of PMS, manufacturers should:
- Integrate PMS into QMS: Ensure PMS is not a standalone process but a core part of your quality framework.
- Develop Tailored PMS Plans: Customize plans for specific devices to capture relevant data and take meaningful actions.
- Define Clear Triggers for Action: Establish thresholds and indicators that guide when corrective or preventive measures are necessary.
- Invest in Training and Expertise: Equip your teams with the knowledge and resources to execute PMS effectively.
- Stay Updated on Regulations: Leverage available guidance documents, including those from the IGJ and European Commission, to align with current standards.
Read here the full IGJ report to understand the findings and actions needed to stay compliant and ensure the safety of your products.
