What is Post-Market Surveillance Under MDR?

Post-Market Surveillance is the systematic process by which manufacturers proactively collect, record, and analyse data on the quality, performance, and safety of their devices once placed on the EU market. Under EU MDR, PMS is explicitly defined as a proactive activity — not reactive complaint handling alone. MDR requires manufacturers to: actively seek data from field use (not just wait for complaints), systematically review scientific and clinical literature, monitor equivalent devices and similar technologies, analyse EUDAMED data on vigilance and field safety, and integrate all findings back into risk management, clinical evaluation, and design improvement processes.

PMS Plan: The Foundation Document

Every device must have a Post-Market Surveillance Plan (Annex III, Section 1.1). The PMS Plan must describe: the methods for proactively gathering PMS data (surveys, registries, literature reviews, distributor feedback systems), the frequency of data collection and review, thresholds for triggering corrective action or vigilance reporting, the link to the risk management process, and the responsible persons for PMS activities. The PMS Plan must be device-specific — a single generic PMS plan for all devices is not acceptable under MDR. Notified Bodies routinely review PMS Plans for adequacy and specificity.

Post-Market Surveillance Report (PMSR) vs PSUR

MDR requires two types of PMS output documents depending on device class: Post-Market Surveillance Report (PMSR) — required for Class I devices; summarises PMS data and conclusions; no defined update frequency but must be updated when significant new data arises. Periodic Safety Update Report (PSUR) — required for Class IIa, IIb, and III devices; must be updated at least every 2 years for Class IIa, annually for Class IIb and III. The PSUR is a formal document that must include: a summary of PMS data, analysis of benefit-risk ratio, conclusions regarding the continued acceptability of residual risks, and assessment of whether device performance matches the claimed intended purpose. PSURs for Class IIb and III devices must be submitted to the Notified Body and will eventually be uploaded to EUDAMED.

Post-Market Clinical Follow-Up (PMCF)

For most Class IIa and above devices, Post-Market Clinical Follow-Up (PMCF) is a required component of PMS. PMCF is the active collection of clinical data from the device in use — going beyond passive complaint monitoring. PMCF methods include: systematic literature surveillance (structured searches of PubMed, EMBASE, and other clinical databases), patient registries, post-market clinical studies, surveys of healthcare professionals, analysis of complaint and adverse event data from a clinical perspective, and participation in national clinical registries where available. PMCF data is summarised in a PMCF Evaluation Report, which feeds into the Clinical Evaluation Report (CER) and the PSUR.

Complaint Handling and Vigilance Integration

PMS and complaint handling are closely integrated systems. Every customer complaint must be evaluated for: whether it constitutes a serious incident requiring vigilance reporting to national competent authorities, whether it indicates a trend requiring a trend report, whether it indicates a design or manufacturing issue requiring CAPA, and what it reveals about real-world device performance relative to intended performance. EU MDR vigilance reporting timelines are strict: serious incidents (actual or potential death or serious deterioration in health) must be reported to the national competent authority within 15 days; immediately dangerous situations within 24 hours. Failure to meet vigilance reporting timelines is among the most serious MDR non-conformities.

PMS Practical Checklist

Confirm the following are in place: ☑ PMS Plan exists for each device, with specific data collection methods and review frequencies ☑ Literature surveillance searches conducted at defined intervals (quarterly for high-risk devices, semi-annually for lower risk) ☑ Distributor and customer feedback collection system in place (surveys, feedback forms, periodic distributor reports) ☑ Complaint log maintained with seriousness assessment for each complaint ☑ Vigilance reporting procedure documented with 15-day and 24-hour timelines defined ☑ PMCF Plan and PMCF Evaluation Report in place for Class IIa+ devices ☑ PSUR prepared and updated at required frequency ☑ PMS findings documented as input to risk management file and CER updates ☑ Trend analysis conducted at defined intervals to identify statistically significant adverse event patterns

Conclusion

EU MDR's post-market surveillance requirements represent a genuine elevation of manufacturer responsibility for the ongoing safety of their devices. Turkish exporters who build systematic, functioning PMS programmes — with regular literature surveillance, active PMCF, integrated complaint analysis, and timely PSUR preparation — will not only satisfy regulators but will develop a genuine early warning system for performance issues that protects both patients and commercial reputation.