EU MDR Post-Market Surveillance Plan Template

Start the PMS plan with a controlled scope record. MDR Annex III expects the PMS plan to prove compliance with the manufacturer's PMS obligations, so reviewers should be able to identify the device and the plan version without relying on project memory.

Use one row per device, Basic UDI-DI, device family, or justified grouping. If a PSUR later covers several devices, keep the grouping rationale traceable to the PMS plan and the PSUR scope.

Describe the PMS objective in device-specific terms: collect and analyse quality, performance, safety, clinical, complaint, and market-experience data throughout the device lifetime, then use the results to update risk management, benefit-risk determination, clinical evaluation, labelling, usability, and corrective actions.

Do not list data sources as a policy aspiration. For each source, define the owner, source system, review frequency, inclusion rules, analysis method, threshold or signal criterion, and output record.

The PMS plan should state whether a PMCF plan is included or why PMCF is not applicable. Where PMCF is performed, make the link operational: identify which clinical questions, risks, benefit-risk uncertainties, residual risks, contraindications, side-effects, off-label use signals, or performance claims the PMCF activities are meant to address.

For each PMCF activity, capture the method, objective, rationale, known limitation, endpoint, sample or data source, analysis timing, and report output. The PMCF evaluation report should feed the clinical evaluation report, technical documentation, risk management, and PMS report or PSUR.

The PMS plan should show how complaint and field data move from intake to classification, investigation, vigilance reporting, trend analysis, CAPA, and technical-documentation updates. This is where many plans fail: they name a complaint procedure but do not define reportability triage, thresholds, observation periods, or evidence records.

Use separate decision paths for non-incidents, incidents, serious incidents, expected undesirable side-effects, non-serious incidents subject to trend reporting, field safety corrective actions, and recurring well-documented serious incidents handled through periodic summary reporting where agreed with the competent authority.

The PMS plan should identify the required reporting output before data collection starts. Class I devices use the PMS report under MDR Article 85. Class IIa, IIb, and III devices use the PSUR under MDR Article 86. The plan should also state how the output becomes part of, or is linked to, the technical documentation.

For PSUR devices, define the data collection period, preparation period, update frequency, submission or availability route, and any grouping rationale. For class III and implantable devices, include the EUDAMED or notified-body submission logic required by MDR Article 86 and the PSUR guidance.

Finish the PMS plan with a responsibility matrix and evidence register. The goal is not to name every corporate function; it is to make sure each PMS input, decision, escalation, report, and technical-documentation update has an accountable owner and a retained record.

Set review cadence by device risk, PMS signals, PMCF schedule, PSUR or PMS report cycle, notified-body commitments, and design or market changes. Avoid fixed deadlines that are not supported by the device class or source material.