EU Post-market Surveillance, PMCF, PMPF and PSUR Guidance

MDCG 2025-10 provides the current overarching PMS guidance

MDCG 2025-10, published in December 2025, explains post-market surveillance for medical devices and IVDs under the MDR and IVDR. It brings together the PMS system, plan, activities, analysis, actions and links to the wider quality management system.

Supporting guidance includes MDCG 2020-7 and 2020-8 for PMCF planning and evaluation reporting, and MDCG 2022-21 for MDR periodic safety update reports. The Regulations remain legally binding; MDCG documents provide a common practical interpretation.

The PMS system is an integral part of the QMS

Manufacturers must plan, establish, document, implement, maintain and update a PMS system proportionate to device risk and appropriate for device type. It should actively gather and analyse quality, performance and safety information throughout the lifetime of devices placed on the market.

The system needs defined processes, responsibilities, resources, data flows, interfaces and escalation criteria. Its effectiveness should be visible to top management through management review and other governance mechanisms.

Use MTL-111 — Post-market Support for the broader organisational operating model.

The PMS plan defines what will be monitored and how

Each device must be covered by a PMS plan. One plan can cover a justified device family or group where scope is explicit and methods remain suitable. Planning should begin before market placement so data needs, baselines, indicators and responsibilities can influence design and release.

• Identify the devices, variants, markets and lifetime in scope.
• Define proactive and reactive information sources.
• Specify collection methods, frequencies and responsible functions.
• Define analysis methods, denominators, indicators and thresholds.
• Address trend reporting, complaints and incident investigation.
• Reference communication, CAPA, vigilance and field-action procedures.
• Include the PMCF or PMPF plan, or a justified non-applicability rationale.
• Define the applicable PMS report or PSUR output and update interval.

A template is not a plan until it is tailored to the device's risks, claims, uncertainties and installed population.

Combine reactive signals with proactive evidence

“Proactive” means deliberately seeking information rather than waiting for complaints. Assess source quality, completeness, bias and relevance, and use meaningful exposure denominators where possible.

Indicators and thresholds turn data into decisions

Define parameters, denominators, observation periods, methods and thresholds in the pre-market phase, then refine them as experience grows. Analyse frequency, severity, failure mode, subgroup, configuration, market, production period and use exposure where relevant.

Statistical significance is not the only trigger: one serious or novel event may require immediate action. Apply MTL-128 — Statistical Methods and Measurement Assurance proportionately.

PMCF and PMPF actively maintain clinical or performance evidence

Post-market clinical follow-up under the MDR and post-market performance follow-up under the IVDR are continuous processes that update clinical or performance evaluation. They can confirm safety and performance, identify previously unknown risks or limitations, monitor known risks, and evaluate use in representative practice.

Define specific objectives, methods, populations, endpoints, timelines, analysis and how results will affect the clinical or performance evaluation. Activities can include registries, studies, surveys, literature review and analysis of real-world data.

A justification that PMCF or PMPF is not applicable must be device-specific and supported. Low device class or long market history does not automatically remove the obligation to consider it.

Device class determines the principal periodic output

The report is an output of the PMS cycle, not the complete system. Confirm current submission and availability arrangements, including EUDAMED implementation and notified-body expectations.

The PSUR should present an integrated safety and performance conclusion

A PSUR summarises PMS data, main findings and conclusions, benefit–risk determination, PMCF or PMPF findings where applicable, sales and population exposure estimates, use frequency and preventive or corrective actions.

Define a data cut-off, reporting period and version. Reconcile complaint, vigilance, clinical, risk, distribution and field-action data. Explain limitations and changes from earlier reports. The conclusion should state whether existing evidence, risk controls, labelling and technical documentation remain adequate.

MDCG 2022-21 provides detailed guidance for MDR PSURs and useful presentation principles for related reporting.

PMS and vigilance are connected but not interchangeable

PMS continuously collects and analyses post-market information. Vigilance handles defined regulatory reporting of serious incidents, field safety corrective actions and trend reports. A complaint may feed both processes, but not every complaint is a reportable incident.

Record awareness dates, investigation, causality, reportability rationale, submissions, follow-up and linkage to risk and corrective action. Do not delay mandatory reporting while waiting for a complete investigation.

PMS outputs must update the rest of the system

Use surveillance conclusions to update risk management, clinical or performance evaluation, design and manufacturing information, instructions, training, cybersecurity, state-of-the-art assessment, corrective actions and benefit–risk conclusions.

• Risk estimates and acceptability
• Clinical evaluation or performance evaluation
• PMCF or PMPF objectives and methods
• Design inputs and risk controls
• Supplier and production controls
• Labelling and information supplied
• CAPA, FSCA and vigilance decisions
• Management review and resource priorities

A PMS report stating “no new risks” is not credible if complaints, service trends or literature were not systematically evaluated.

Maintain traceable governance and evidence

Assign accountable owners, competent contributors, review and approval. Define interfaces across complaint handling, vigilance, clinical, risk, service, quality, regulatory, cybersecurity and management.

Use consistent device, UDI, batch, software-version and event identifiers. Retain source data, searches, coding decisions, calculations, meeting decisions and actions so the report can be reconstructed and audited. Ensure plans and reports describe the same scope and current device configuration.

Common misconceptions

Practical PMS checklist

• Does every marketed device fall within a defined PMS-plan scope?
• Are data sources proactive as well as reactive?
• Are exposure denominators, indicators and thresholds meaningful?
• Do analysis methods reflect device risk and data quality?
• Is PMCF or PMPF planned, or is non-applicability justified?
• Is the correct PMS report or PSUR frequency applied?
• Are vigilance decisions timely and traceable?
• Do outputs update risk and clinical or performance evaluation?
• Are corrective actions and effectiveness checks connected?
• Can management see the system's effectiveness and unresolved issues?