Medical Device Post Market Surveillance

Post-market surveillance (PMS) systems play a critical role in monitoring medical device safety and performance after they reach the market. Effective PMS helps reduce costs, minimize resource demands, and enhance overall product quality. Before a device is approved for market entry, manufacturers must assess and mitigate risks to safeguard patient safety—an effort that is further evaluated by authorities and notified bodies during authorization and conformity assessments.

Building an Effective PMS System

Medical device and IVD manufacturers must maintain up‑to‑date PMS procedures to ensure regulatory compliance and avoid costly recalls. A strong PMS system supports ongoing product safety and quality, requiring coordination across teams such as QA/RA, manufacturing, design, field sales, and technical support.

PMS activities fall into two categories—reactive and proactive. While reactive processes are widely used, incorporating proactive measures significantly strengthens PMS effectiveness by ensuring continuous product quality.

Reactive (Incident‑Driven) PMS

Reactive PMS focuses on monitoring and responding to issues as they arise. This includes maintaining updated risk management files and identifying events that require investigation. Examples include:

• Serious incident reports, including field safety corrective actions 
• Records of non-serious incidents and undesirable side effects 
• Trend reports and related actions 
• Feedback and complaints from users, distributors, and importers 

Proactive (Review‑Driven) PMS

Proactive PMS broadens surveillance activities by identifying potential risks before they escalate. This may involve reviewing nontraditional information sources such as online forums, product reviews, social media, and professional discussions. Key proactive PMS sources include:

• Specialist literature, technical publications, databases, and registries 
• Public information on comparable devices (e.g., FDA Total Product Life Cycle database) 
• Insights from other industries using similar technology 
• Competitor innovations or emerging alternative technologies 

PMS Sources:

Expanding the range of PMS sources helps manufacturers identify issues earlier and uncover opportunities for improvement that may not surface through complaint reporting alone.

FDA and EU Approaches to PMS

FDA Approach

Under Section 522 of the Federal Food, Drug, and Cosmetic Act, the FDA may mandate PMS for certain Class II and Class III devices, including:

• Devices with possible serious adverse health consequences if they fail 
• Devices implanted for more than one year 
• Life‑sustaining or life-supporting devices used outside clinical facilities 
• Devices expected to have significant pediatric use 

Examples include infusion pumps (Class II), implantable pacemakers (Class III), and HIV diagnostic tests (Class III). 

The FDA may require surveillance for up to 36 months or longer, and manufacturers must comply within 15 months of receiving a PMS order.

EU Approach

Post‑Market Clinical Follow‑Up (PMCF) studies—outlined in MEDDEV 2.12/2 Rev. 2 (January 2012)—are required for devices that present residual risks or require additional clinical performance data. PMCF is typically needed for:

• Innovative products 
• Devices that have undergone major modifications 
• Devices with high inherent risks or used in sensitive anatomical locations 
• Devices used in high‑risk patient populations 
• Conditions with severe disease impact 
• Situations where uncertainties remain regarding safety or performance 
• Incomplete or inconclusive clinical trial results 
• Emerging safety or performance findings 

These PMS activities strengthen post‑market safety monitoring, ensure ongoing compliance, and support continuous device improvement throughout its lifecycle.