Common Misconceptions and Best Practices in PMS, Vigilance, and Reporting
Key Gaps and Effective Practices in Post-Market Surveillance
Azam Khorshidi, Technical File Reviewer IVD, DEKRA Certification
A common misconception about post-market surveillance (PMS) is that it’s a one-time requirement rather than an ongoing process.
[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]
Despite regulatory requirements emphasizing continuous monitoring, recent findings by the Dutch competent authority, the Health and Youth Care Inspectorate (IGJ), reveal persistent compliance gaps in PMS. A 2023-2024 review by the IGJ of 13 medical device (MD) and in vitro diagnostic (IVD) manufacturers revealed that none fully adhered to post-market regulatory requirements.
Specifically, these compliance gaps manifest in key areas. IGJ inspections found manufacturers often collected information inconsistently, lacking predefined data sources, thresholds, and action triggers, hindering trend identification and risk mitigation.
Furthermore, PMS plans were frequently too generic and lacked clear benefit-risk reassessments in PSURs, weakening compliance and patient safety.
Beyond IGJ observations, Notified Bodies have also identified common PMS issues, including unclear plan methods and thresholds, failure to communicate PSUR submission dates for legacy devices, and lack of notification regarding significant PMCF plan changes.
Additionally, many manufacturers fail to integrate PMS into their quality management system (QMS), leading to fragmented data collection and analysis.
To address these shortcomings and ensure effective PMS, manufacturers must adopt a more proactive and risk-based approach. An effective PMS strategy balances proactive and reactive measures. While vigilance and complaint handling are necessary, proactive approaches—such as post-market clinical follow-up (PMCF), user surveys, and real-world performance monitoring—help identify risks before they escalate. A risk-based approach is also crucial, with high-risk or novel devices requiring more intensive monitoring than lower-risk products.
“An effective PMS strategy balances proactive and reactive measures.”
In cases where manufacturers have had prior issues, such as field safety corrective actions (FSCAs) or recalls,
a heightened level of PMS is required. Enhanced trend analysis, stricter CAPA, and targeted PMCF help ensure past issues don’t resurface and new issues are identified at an early stage. A critical regulatory requirement under MDR and IVDR is integrating PMS with risk management, continuously updating risk-benefit assessments based on real-world data—failure to do so can jeopardize compliance.
“A risk-based approach is also crucial, with high-risk or novel devices requiring more intensive monitoring than lower-risk products.”
Ultimately, PMS isn’t just about meeting regulatory obligations—it safeguards patients, strengthens manufacturer credibility, and, when done right, provides a competitive advantage by adding to the evidence of the device’s safety and performance.
Azam Khorshidi is an IVD regulatory professional and biocompatibility expert with deep experience in technical file review, IVDR/MDR compliance, and post-market regulatory strategy.
Currently at DEKRA, she provides expert insights to manufacturers on EU regulatory pathways and regularly shares her perspective through webinars and conferences.
Subscribe to EU MDR & IVDR Insider
