Post-market surveillance · MDR · CE marking
CE marking is the start of the evidence cycle
Post-market surveillance must show what happens when the device leaves the controlled pre-market environment and enters routine use.
An MDR-compliant PMS system does more than collect complaints. It actively searches for information, detects change, tests the benefit-risk conclusion and turns evidence into controlled action.
Complaint rate
Within thresholdNew literature signal
Review requiredService failure mode
Trend risingDoes new evidence change safety, performance or benefit-risk?
Every MDR device, including class I
Continuous, systematic and proactive
PMS plan plus PMS report or PSUR
Evidence-based action, not data storage
The operating model
PMS is a closed evidence loop
Collection has no regulatory value unless the information is assessed, connected to the device’s existing evidence and converted into a documented decision.
Define what to monitor
Set sources, frequencies, responsibilities, methods, denominators, indicators and action thresholds.
Actively seek information
Gather device-specific experience and relevant external evidence instead of waiting for complaints.
Test signals and trends
Use meaningful exposure data, severity, expected rates and predefined statistical or qualitative methods.
Control the consequence
Update risk, clinical evidence, design, labelling, CAPA, PMCF or regulatory reporting where needed.
Confirm effectiveness
Check whether the action reduced the issue and feed the result into the next PMS cycle.
A PSUR or PMS report summarises the work already performed. A safety signal, reportable incident or unacceptable risk must be handled when identified, not held until the next scheduled report.
Article 85 or Article 86
Choose the device class to see the reporting route
The PMS system applies to every class. What changes is the report, minimum update frequency and route for making the result available.
PMS report · Article 85
Summarise the data, conclusions and preventive or corrective actions
Update the report when necessary in accordance with the PMS plan. Keep it within the technical documentation and make it available to the competent authority on request.
Defined in the PMS plan
Whenever new evidence requires it
Competent authority on request
PSUR · Article 86
Update at least once every two years and whenever necessary
For non-implantable class IIa devices, make the PSUR available to the notified body and competent authority on request. Implantable devices follow the submission route applicable to class III and implantable devices.
Every two years
Benefit-risk, PMCF, sales and population data
Depends on implantable status
PSUR · Article 86
Update at least annually and whenever necessary
For non-implantable class IIb devices, make the PSUR available on request. For implantable class IIb devices, use the applicable submission channel for the notified body.
Every year
Conclusions, exposure, PMCF and actions
Depends on implantable status
PSUR · Article 86
Update at least annually and submit through the applicable regulatory channel
The notified body evaluates the PSUR. Until the EUDAMED Vigilance and PMS module becomes mandatory, manufacturers continue to follow the applicable national process and notified-body arrangements.
Every year
Evaluation required
Current applicable channel
The stated frequencies are minimums. New information can require immediate assessment, regulatory reporting, corrective action or an earlier report update.
Proactive collection
Build the source map before data arrive
For each source, define ownership, access, frequency, coding rules, denominator, analysis method and the decision that a threshold can trigger.
One controlled dataset
Complaints and incidents
Failure mode, harm, severity, cause, batch and reportability
Sales and exposure
Units, procedures, patients, use time and market distribution
Service and returns
Repairs, diagnostics, replacement parts and recurrent faults
Users and economic operators
Surveys, training feedback, importer and distributor information
Clinical and scientific evidence
PMCF, registries, studies, literature and state of the art
Production and suppliers
Nonconformities, yield, incoming controls and supplier changes
Similar devices
Public safety notices, recalls, literature and comparable technology
Regulatory intelligence
Authority communications, standards, guidance and new requirements
The denominator problem
Counts do not show whether risk is changing
Ten complaints can mean very different things. The interpretation depends on how many devices were used, for how long, in which population and under which conditions.
validated complaintsrelevant exposure
Units sold or actually used?
Unique devices, procedures or patients?
Installed base or time at risk?
Comparable markets and reporting behaviour?
From signal to action
One data point can enter several regulatory processes
Select an example to see the parallel questions the team should answer. The routes are connected and may all apply to the same event.
A user reports an unanticipated serious deterioration in health
Do not wait for root-cause certainty before starting vigilance assessment. The awareness date controls the reporting clock.
Assess serious-incident criteria and reporting deadline immediately.
Check whether the hazard, sequence and severity were identified correctly.
Determine containment, affected population and field action.
Assess whether the event changes clinical safety or benefit-risk.
A known non-serious failure rises above the predefined threshold
Confirm the denominator and observation period, investigate reporting changes and apply the trend method defined in the PMS plan.
Assess the Article 88 criteria and applicable authority route.
Compare batches, sites, suppliers, changes and process capability.
Recalculate occurrence and reassess risk acceptability.
Investigate systemic cause and define measurable effectiveness.
Published evidence challenges the accepted state of the art
Document relevance to the device and intended population, then assess whether existing clinical evidence and risk controls remain sufficient.
Update the literature appraisal and state-of-the-art comparison.
Convert the new uncertainty into a focused clinical objective.
Check for a new hazard, harm or changed probability.
Assess claims, warnings, contraindications and user information.
Observed safety and performance remain within expected limits
A “no new signal” conclusion still needs traceable sources, completed activities, suitable exposure data and a documented assessment.
Confirm that the existing conclusion remains supported.
Explain the dataset, method, limitations and conclusion.
Reassess whether sources and thresholds remain sensitive enough.
Report PMS effectiveness and any resource or process needs.
Serious public health threat
Death or unanticipated serious deterioration
Other reportable serious incidents
The update network
PMS must change the documents it tests
A frequent audit gap is a well-written report whose conclusions never reach the controlled lifecycle documents or operational processes.
Risk management file
New hazards, occurrence estimates, residual risk, control effectiveness and overall benefit-risk.
Clinical evaluation
Clinical safety, performance, claims, state of the art, evidence gaps and continuing acceptability.
PMCF plan and report
Residual uncertainty, long-term effects, underrepresented users and confirmation of clinical performance.
Design and labelling
Design changes, warnings, contraindications, instructions, usability and user training.
CAPA and nonconformity
Root cause, extent, systemic action, implementation evidence and effectiveness checks.
Production and suppliers
Process controls, acceptance criteria, supplier monitoring, batch traceability and change control.
Vigilance and field action
Incident reports, trends, FSCAs, safety notices and communication with authorities and users.
Management review
System effectiveness, unresolved signals, overdue activities, resources and strategic decisions.
Annex III planning test
Eight questions your PMS plan should answer
Use the checklist as a structural test. Device-specific methods, indicators and acceptance thresholds still need a documented rationale.
Common audit findings
Four PMS shortcuts that do not work
The weakness is usually not the absence of data. It is the absence of a planned method for converting data into a timely, controlled conclusion.
Proactive PMS must search for information beyond complaints and document why the dataset is sufficient.
The denominator must reflect real exposure. A reusable device, implant and single-use accessory need different measures.
A new risk signal must be assessed when detected. The report records the decision; it does not postpone it.
Grouping is acceptable only when scope, sources, methods and thresholds remain appropriate for every included device.
Practical questions
Questions manufacturers ask about PMS
The plan and report must remain specific to the device, its risk, clinical evidence, market experience and current regulatory route.
Yes. Every MDR device needs a post-market surveillance system and a PMS plan. A class I manufacturer documents the results and conclusions in a PMS report under Article 85, updates it when necessary and makes it available to the competent authority on request.
PMS planning should begin during device development, before CE marking. Active collection starts when the first device is placed on the market or put into service and continues throughout the period in which devices remain in use, including the lifetime of the last device placed on the market.
No. Complaints are only one input. The PMS plan must provide a proactive and systematic process for collecting and analysing relevant information, which may include user feedback, literature, registries, service data, distributor information, PMCF, similar-device information and post-market studies.
PMS is the broad continuous system for collecting and using post-market information. Vigilance is the regulatory process for reportable serious incidents, field safety corrective actions and related communications. Vigilance data feed the PMS system, but the two are not interchangeable.
The PMS plan must include a PMCF plan or a documented justification explaining why PMCF is not applicable. The justification must be device-specific and consistent with the clinical evaluation, risk profile, available clinical evidence and residual uncertainties.
Yes. A plan may cover a device family or a justified group of devices, but its scope must be explicit. The devices should be sufficiently related in intended purpose, design, technology, manufacture and risk profile for the selected sources, methods and thresholds to remain meaningful.
Under Article 86, class IIa PSURs are updated when necessary and at least every two years. Class IIb and class III PSURs are updated when necessary and at least annually. Earlier updating may be required when new information changes the benefit-risk determination or requires action.
Primary sources
Use the current legal text and guidance
The MDR creates the legal obligations. MDCG documents provide the current common understanding of practical implementation but are not legally binding.
Regulation (EU) 2017/745
Articles 83–90, Annex III and Annex XIV Part B
MDCG 2025-10
Current guidance on the PMS system, PMS plan and QMS interfaces
MDCG 2022-21
Detailed guidance on preparing and managing the MDR PSUR
MDCG 2023-3 rev.2
Questions and answers on vigilance terms, concepts and timelines
MDCG 2020-7 and 2020-8
PMCF plan and PMCF evaluation report guidance
EUDAMED information centre
Current module status and implementation information
Make the evidence operational
Need a PMS system that works beyond the report?
MDRC can review your PMS plan, data sources, thresholds, reporting route and links to risk management, clinical evaluation, PMCF, vigilance and CAPA.
