Post-Market Surveillance for Medical Devices

Post-Market Surveillance (PMS) of medical devices is a critical regulatory and quality requirement that ensures the ongoing safety, performance, and real-world effectiveness of devices after they reach the market. With evolving global regulations such as EU MDR and FDA post-market requirements, manufacturers must continuously monitor adverse events, analyze field data, and proactively manage risks. Freyr supports medical device companies with end-to-end post-market surveillance services, from complaint handling to PMSR/PSUR/PMCF reporting, helping businesses stay compliant, avoid recalls, and maintain market competitiveness.

1000

PMS Reports, PMCF, SSCP

Therapeutic Areas Supported

100

PMS Reports, PMCF SSCP

99%

On- Time Submission

Why Post-Market Surveillance Matters in the Medical Device Lifecycle

Post-Market Surveillance (PMS) is a critical element of the medical device lifecycle, especially under evolving regulations such as EU MDR, IVDR, and FDA post-market requirements. As devices become more advanced, spanning SaMD, wearables, and connected technologies, continuous real-world monitoring and proactive risk detection are essential. Industry trends such as real-world evidence (RWE), digital vigilance, and patient-reported outcomes highlight the need for ongoing evaluation of device safety, performance, and clinical benefit. As part of modern post-marketing surveillance expectations, manufacturers must increasingly incorporate trend reporting, signal detection, and risk-based assessments.

Despite its importance, many manufacturers face challenges in meeting PMS expectations. Fragmented data sources, inconsistent global reporting obligations, multilingual complaint channels, and increasing regulatory scrutiny create operational complexity. Preparing PMS Plans, PMSRs, PSURs, and PMCF documentation, requires specialized expertise, accurate data interpretation, and cross-functional coordination. Gaps in trending, signal detection, Health Hazard Evaluation (HHE), or medical device vigilance reporting can lead to audit findings, potential recalls, or risks to product continuity.

Freyr addresses these challenges with comprehensive, end-to-end PMS solutions designed for global regulatory demands. Our teams combine regulatory expertise, structured methodologies, and multilingual support to streamline complaint handling, vigilance reporting, and PMS documentation. With proven experience across Class I–III, IVD, and SaMD devices, Freyr ensures high-quality reporting, timely compliance, and audit readiness, making us a trusted partner for medical device manufacturers seeking reliable and efficient PMS lifecycle management.

Key Components of Post-Market Surveillance for Medical Devices

Effective Post-Market Surveillance (PMS) combines multiple interconnected activities that monitor device safety, clinical performance, user experience, and emerging risks throughout the product’s commercial life. These components form the foundation of global regulatory expectations under EU MDR, IVDR, and FDA post-market requirements. Understanding each element is essential for maintaining compliance, improving real-world device performance, and proactively mitigating safety concerns.

Complaint & Adverse Event Management

Structured intake, investigation, and trending of complaints to detect early safety signals, ensure timely escalation, and maintain global compliance with FDA, EU MDR, and regional vigilance reporting expectations.
Vigilance Reporting

Timely identification, assessment, and reporting of adverse events and serious incidents to global regulators, ensuring continuous safety oversight and alignment with FDA MDR and EU MDR vigilance requirements.
Recalls, Corrections & Removals

End-to-end management of field corrective actions, including risk evaluation, Health Hazard Evaluation (HHE), regulatory notifications, communication, and effectiveness checks to safeguard patient safety and protect market credibility.
PMS Plan (PMSP)

A structured post-market surveillance plan defining responsibilities, data sources, processes, and evaluation criteria to ensure consistent, proactive monitoring of device performance throughout its lifecycle.
PMSR, PSUR & PMCF

Regulatory-mandated reports summarizing post-market data, including the post-market surveillance report (PMSR), benefit–risk updates, and clinical follow-up activities to demonstrate ongoing device safety and performance.
Trend Reporting & Real-World Evidence

Analysis of complaint patterns and real-world performance data to identify emerging risks, support preventive actions, and enhance product reliability through structured trend reporting practices.