EU MDR Post-Market Surveillance and Vigilance

Article 83 requires a post-market surveillance system for each device that is proportionate to risk class and appropriate for the device type. The system belongs inside the manufacturer's quality management system, so support tickets, complaint handling, service records, distributor feedback, literature review, registry data, and clinical follow-up should feed the same controlled process.

The output is not only a log. MDR PMS data is used to update benefit-risk determination, risk management, design and manufacturing information, instructions for use, labelling, clinical evaluation, the summary of safety and clinical performance where relevant, and needs for preventive, corrective, or field safety corrective action.

The PMS plan is the operating design for collecting and analysing post-market data. Article 84 points to Annex III and requires the plan to be part of technical documentation for devices other than custom-made devices.

The report type depends on class. Class I manufacturers prepare a PMS report summarising analysis results, conclusions, and the rationale and description for preventive and corrective actions. Class IIa, IIb, and III manufacturers prepare a PSUR for each device, or where relevant each category or group of devices, with conclusions from benefit-risk determination, main PMCF findings, sales volume, user population estimates, and usage frequency where practicable.

PMCF is part of PMS, but it has a clinical evidence job. MDR Annex XIV treats PMCF as a continuous process that updates clinical evaluation and requires a documented PMCF plan. MDCG 2020-7 gives a practical structure for the plan: manufacturer and device details, PMCF activities, links to technical documentation, clinical evaluation and risk management references, equivalent or similar device data, standards or guidance, and the estimated date of the PMCF evaluation report.

A usable PMCF record explains why each activity is needed, what data quality is expected, which endpoints or questions are being answered, what limitations exist, when analysis and reporting will happen, and how findings flow back into the clinical evaluation report, technical documentation, and risk controls.

Vigilance starts with triage. Article 87 requires manufacturers to report serious incidents involving devices made available on the Union market, except expected side-effects that are clearly documented, quantified in technical documentation, and subject to trend reporting. The same article covers field safety corrective actions, including third-country FSCAs for a device also legally made available on the Union market when the reason is not limited to the third-country device.

Trend reporting is a different route. Article 88 covers statistically significant increases in the frequency or severity of non-serious incidents or expected undesirable side-effects that could significantly affect benefit-risk analysis and may create unacceptable health or safety risks. The PMS plan should specify the methodology, observation period, and handling approach for those trend signals.

MDR Article 92 establishes the electronic system for vigilance and PMS information, including serious incident and FSCA reports, periodic summary reports, trend reports, PSURs, field safety notices, and competent-authority exchanges. Treat the EUDAMED submission record as part of the evidence file, not as a substitute for investigation, risk, clinical, and CAPA records.

Commission Implementing Regulation (EU) 2021/2078 adds operating rules for EUDAMED access, support, and malfunctions. If a malfunction prevents required submissions, the record should show the malfunction notice, any suspension of submission periods, interim information sent to the Commission, competent authorities, or notified body when required, and the later EUDAMED entry once the malfunction ceased.

A reviewer should be able to reconstruct the full chain from signal to decision. Keep records at device and version level, and preserve links between PMS analysis, clinical evaluation, risk management, PMCF, vigilance reports, field safety actions, CAPA, notified-body review, and EUDAMED submission evidence.

Avoid unsupported timeline claims or national penalty detail in the PMS file. The stronger record is factual: MDR article route, device scope, data source, method, assessment, decision, report or update made, authority communication, and follow-up monitoring.