EU MDR post-market work requires more than complaint handling. Manufacturers need a documented PMS system and plan that actively collects safety and performance data, updates technical documentation and clinical evaluation, and feeds vigilance decisions.
This page helps structure PMS plans, PMCF updates, PMS reports or PSURs, serious incident and FSCA reporting, trend reporting, EUDAMED caveats, and the evidence records reviewers will expect.
Structured answer sets in this page tree.
Cited legal and guidance references.
Under EU MDR Articles 83 to 89, and vigilance are linked systems: PMS continuously gathers and analyses market data, while vigilance escalates serious incidents, , field safety notices, and reportable trends. Keep a traceable record from each complaint or signal through evaluation, reportability decision, CAPA or FSCA, clinical evaluation update, and technical documentation update.
For each device, the manufacturer must plan, establish, document, implement, maintain, and update a system proportionate to risk class and device type. The system belongs inside the quality management system and must actively and systematically gather, record, and analyse quality, performance, and safety data throughout the device lifetime.
The plan is the operating document for that system. Annex III expects it to cover serious incidents, information, FSCAs, non-serious incidents, undesirable side-effects, trend reporting, literature, registers or databases, user feedback, complaints, distributor and importer inputs, public information about similar devices, assessment methods, indicators, thresholds, complaint investigation tools, communication methods, corrective-action procedures, traceability tools, and a PMCF plan or a justified reason why PMCF is not applicable.
MDCG 2025-10 clarifies that each device must be covered by a plan, although one plan may cover a clearly identified group of devices. The plan should state what is monitored, how often, which methods apply, and why those methods fit the device's risk profile. Proactive collection means actively seeking information from suitable sources instead of waiting for complaints.
Map PMS data streams, PMCF updates, PMS report or PSUR outputs, vigilance triage, FSCA/FSN handling, trend thresholds, and EUDAMED or alternative submission records into one reviewable evidence trail.
PMCF is a continuous process that updates the clinical evaluation. It must be addressed in the plan and uses clinical data from real use of the CE-marked device within its intended purpose to confirm safety and performance, keep identified risks acceptable, and detect emerging risks.
The PMCF plan should be device-specific. It should name the general methods, such as clinical experience, user feedback, scientific literature, and other clinical data sources, plus any specific methods such as registries or PMCF studies. It should also connect to the clinical evaluation report and risk management file, explain why the chosen methods are appropriate, and define a justified schedule for PMCF activities and reporting.
The output changes by device class. Class I manufacturers prepare a report that summarises PMS data analysis, conclusions, and the rationale and description for preventive or corrective actions. Class IIa, IIb, and III manufacturers prepare a for each device and, where relevant, each category or group of devices.
A should summarise analysis, conclusions, preventive and corrective actions, benefit-risk conclusions, main PMCF findings, sales volume, estimated population using the device, population characteristics, and usage frequency where practicable. MDCG 2022-21 treats the PSUR as a stand-alone, organised, searchable document that summarises results and conclusions rather than duplicating every PMS record.
Vigilance starts with reportability triage. MDR Article 87 requires manufacturers to report serious incidents involving Union-market devices, except expected side-effects that are clearly documented, quantified in technical documentation, and handled through Article 88 trend reporting. Article 87 also requires reporting of FSCAs for Union-market devices, including third-country FSCAs for a device also legally available in the Union unless the reason is limited to the third-country device.
MDCG 2023-3 frames a reportable serious incident around three checks: an incident occurred, it led or might lead to a serious health or public-health outcome, and a causal relationship with the manufacturer's device is established, reasonably possible, or suspected. If the manufacturer is uncertain whether a potentially reportable incident is reportable, the MDR requires reporting within the applicable timeframe.
A defensible and vigilance file should show the route from signal to decision. Keep the raw signal, triage, reportability assessment, trend calculation, risk analysis, benefit-risk conclusion, CAPA or FSCA decision, communications, authority submissions, notified-body interactions, and the updates made to clinical evaluation and technical documentation.
EUDAMED is part of the MDR reporting architecture. The Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules became mandatory on 28 May 2026, but the Commission still lists the Vigilance and Post-Market Surveillance module as in development. MDCG 2024-11 says manufacturers and authorised representatives must continue using national processes until that module becomes mandatory. Keep evidence of the route used now and prepare to move open follow-up actions into EUDAMED when the module becomes mandatory; the guidance does not require retrospective entry of the original report.
"lifecycle of medical devices"
"Activities related to PMCF"
"data collection period covered by the PSUR"
"must nevertheless submit a report"
"economic operators need to continue using the national processes"
"Each device must be covered by a PMS plan"
"clear, organised, readily searchable and unambiguous"