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Artifact TemplateEU MDR

EU MDR Post-Market Surveillance Plan Template

Build the PMS plan around the specific device, its risk class, intended purpose, lifecycle data, PMCF activities, vigilance routes, complaint handling, trend thresholds, and the report output required for its class.

The fields below help as a working structure for the technical documentation required by MDR Article 84 and Annex III.

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Author
Sorena AI
Published
May 9, 2026
Updated
Jul 24, 2026
Sections
6

Structured answer sets in this page tree.

Primary sources
6

Cited legal and guidance references.

Publication metadata
Sorena AI
Published May 9, 2026
Updated Jul 24, 2026
Overview

This template is for manufacturers drafting or refreshing an EU MDR post-market surveillance plan. It converts MDR Articles 83 to 88 and Annex III into practical fields: what device is covered, what data will be collected, how PMCF feeds the clinical evaluation, how complaints and vigilance are routed, and whether the output is a PMS report or .

Section 1

1. Device scope and plan control

Start the 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.

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

  • Plan control: number, version, effective date, revision history, approving function, and next planned review.
  • Manufacturer and operator details: legal manufacturer, SRN where applicable, authorised representative where applicable, PRRC, complaint intake owner, vigilance owner, PMS owner, clinical owner, and notified body contact where applicable.
  • Device identity: product or trade name, model and type, Basic UDI-DI, variants, configurations, accessories, certificate number if available, nomenclature code, risk class, classification rule, and custom-made status where relevant.
  • Intended use profile: intended purpose, intended users, intended patient population, medical conditions, indications, contraindications, warnings, expected lifetime, and whether novel product or procedure features change the PMS evidence strategy.
  • Market scope: EU markets covered, first placing on the market or MDR certification reference, active distribution status, and whether legacy-device PMS, vigilance, registration, or obligations still need tracking.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
MDR Articles 83 and 84 require a PMS system and PMS plan; Annex III specifies PMS plan content and technical-documentation expectations.
MDCG 2020-7 PMCF plan template
MDCG 2020-7 provides useful device-description fields for the PMCF part of the PMS plan, including intended purpose, Basic UDI-DI, variants, risk class, and expected lifetime.
Section 2

2. PMS objectives and data sources

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.

Article 83 makes the manufacturer responsible for a PMS system proportionate to the risk class and appropriate for the device type. Importers, distributors, authorised representatives, users, and service channels can supply data. The manufacturer retains the duty to collect, analyse, act on, and document the results.

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.

  • Safety and performance data: serious incidents, field safety corrective actions, non-serious incidents, undesirable side-effects, trend reports, complaint files, service records, returned-product analysis, CAPA records, and user feedback.
  • Clinical and scientific data: PMCF activities, registry data, literature searches, case reports, clinical evaluation updates, data on equivalent or similar devices, and publicly available information about similar devices.
  • Market and operator inputs: feedback from users, distributors, importers, authorised representatives, competent authorities, notified bodies, procurement or support channels, and post-release monitoring.
  • Analysis method: define how each source is characterised, trended, compared to similar products where relevant, escalated to risk management, and converted into preventive, corrective, or field safety corrective action decisions.
  • Plan outputs: updated risk management file, clinical evaluation, PMCF evaluation report, instructions for use or labelling changes, SSCP updates where applicable, PMS report, , vigilance reports, trend reports, and CAPA evidence.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
MDR Article 83 sets the PMS system objective and identifies how PMS data feeds risk management, clinical evaluation, labelling, SSCP, usability, performance, safety, and trend reporting. Annex III lists the information sources and methods the PMS plan must address.
Section 4

4. Complaints, vigilance, trend reporting, and CAPA

The 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.

  • Complaint intake fields: source, date received, device identifier, lot or serial number where relevant, reporter type, event description, patient or user outcome, information supplied by the manufacturer involved, and whether a device issue is alleged.
  • Incident triage: classify whether the information is an incident under MDR Article 2(64), whether it meets serious-incident criteria, whether uncertainty remains, and who approves the reportability decision.
  • Vigilance route: define MIR preparation, competent-authority destination, notified-body notification where applicable, FSCA and FSN routing, periodic summary reporting conditions, and how national processes or EUDAMED VGL processes are followed when applicable.
  • Trend reporting method: define the observation period, expected frequency or severity baseline, statistical method, trigger threshold, benefit-risk impact check, and escalation route for trend reports under MDR Article 88.
  • CAPA and technical-documentation updates: document root-cause investigation, risk assessment, preventive or corrective action, FSCA decision, effectiveness checks, and updates to risk management, clinical evaluation, IFU, labelling, PMS outputs, and PMCF activities.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
MDR Articles 83, 87, and 88 ground CAPA escalation, serious-incident and FSCA reporting, and trend-reporting methods that must be specified in the PMS plan.
MDCG 2023-3 Rev.2 vigilance Q&A
MDCG 2023-3 clarifies incident versus serious incident concepts, reportability uncertainty, complaint and PMS sources, MIR reporting, trend reports, and interim notified-body information handling before mandatory VGL use.
Section 5

5. PMS report or PSUR output

The 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 under MDR Article 86. The plan should also state how the output becomes part of, or is linked to, the technical documentation.

For 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.

  • PMS report path: for class I devices, summarise PMS data analysis, conclusions, and rationale and description for preventive and corrective actions; update when necessary and make available to competent authorities on request.
  • path: for class IIa, IIb, and III devices, summarise PMS data analysis, benefit-risk conclusions, main PMCF findings, sales volume, estimated user population, usage frequency where practicable, and preventive or corrective actions.
  • update frequency: class IIb and III at least annually; class IIa when necessary and at least every two years; custom-made device PSURs sit in the custom-made device documentation where applicable.
  • Submission or availability: Article 86 requires class III and implantable PSURs to be submitted through the Article 92 electronic system to the notified body involved in conformity assessment. The Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules became mandatory on 28 May 2026, but the EUDAMED Vigilance and PMS module remains under development. Use the applicable interim route until that module becomes mandatory. Other PSURs are made available to the notified body and competent authorities upon request.
  • grouping: if one PSUR covers multiple Basic UDI-DIs or device families, justify the grouping, identify the leading device where used, keep device-specific performance data readable, and avoid hiding signals across different risk profiles.
Sources for this answer
Regulation (EU) 2017/745 on medical devices
MDR Articles 85 and 86 define PMS report and PSUR outputs, class-based update frequencies, PSUR content, and submission or availability routes.
MDCG 2022-21 PSUR guidance
MDCG 2022-21 provides PSUR scope, grouping, data collection period, issuance, submission, and schedule guidance for MDR and legacy devices.
European Commission - EUDAMED overview
Confirms that the Vigilance and post-market surveillance module remains under development as of 24 July 2026.
Recommended next step

Turn the PMS plan into traceable MDR evidence

Use Sorena to keep PMS sources, complaint signals, PMCF records, PSUR or PMS report outputs, citations, owners, and review triggers connected across the medical device technical documentation.

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Answer MDR PMS, PMCF, vigilance, and PSUR questions with cited outputs.

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Section 6

6. Responsibilities, review cadence, and evidence records

Finish the 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, 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.

  • Responsibility matrix: owner, QMS owner, complaint handler, vigilance reporter, PRRC, clinical evaluation owner, PMCF owner, risk management owner, regulatory affairs owner, post-market data analyst, CAPA owner, and final approver.
  • Scheduled review triggers: PMS report update, cycle, PMCF evaluation report date, management review, notified-body surveillance, risk-management review, clinical evaluation update, and defined trend-observation periods.
  • Event-driven review triggers: serious incident, FSCA, trend threshold breach, repeated complaint pattern, new or changed risk, label or IFU change, intended-purpose change, design or supplier change, new clinical evidence, registry signal, authority request, or notified-body feedback.
  • Plan-change record: when a signal, new data source, changed market, device change, or authority or notified-body request alters the surveillance method, threshold, cadence, or responsibility, revise and approve the and retain the reason for the change.
  • Evidence register: approved , data-source inventory, raw-data extracts or query records, complaint files, vigilance decisions, MIR or FSCA records, trend calculations, CAPA records, PMCF plan and evaluation report, PMS report or , technical-documentation updates, and approval history.
  • Traceability rule: every conclusion in the PMS report or should trace back to a PMS data source, analysis method, date range, owner, and decision record.
Sources for this answer
Regulation (EU) 2017/745 Annex III
Annex III requires clear, organised, searchable PMS technical documentation and PMS plan methods for collection, assessment, complaints, trend reporting, communications, corrective actions, traceability, PMCF, and PMSR or PSUR outputs.
MDCG 2020-7 PMCF plan template
MDCG 2020-7 supports the PMCF evidence register by tying PMCF activities to clinical evaluation, risk management, technical documentation, and PMCF evaluation report timing.
Primary sources

References and citations

MDCG 2020-7 PMCF plan template
health.ec.europa.eu
Referenced sections
  • MDCG 2020-7 supports the PMCF evidence register by tying PMCF activities to clinical evaluation, risk management, technical documentation, and PMCF evaluation report timing.
"clinical evaluation report and the technical documentation"
MDCG 2022-21 PSUR guidance
health.ec.europa.eu
Referenced sections
  • MDCG 2022-21 provides PSUR scope, grouping, data collection period, issuance, submission, and schedule guidance for MDR and legacy devices.
"more consistent, standardized and systematic review"
MDCG 2023-3 Rev.2 vigilance Q&A
health.ec.europa.eu
Referenced sections
  • MDCG 2023-3 clarifies incident versus serious incident concepts, reportability uncertainty, complaint and PMS sources, MIR reporting, trend reports, and interim notified-body information handling before mandatory VGL use.
"must still investigate"
Regulation (EU) 2017/745 Annex III
eur-lex.europa.eu
Referenced sections
  • Annex III requires clear, organised, searchable PMS technical documentation and PMS plan methods for collection, assessment, complaints, trend reporting, communications, corrective actions, traceability, PMCF, and PMSR or PSUR outputs.
"clear, organised, readily searchable"
Regulation (EU) 2017/745 on medical devices
eur-lex.europa.eu
Referenced sections
  • MDR Articles 85 and 86 define PMS report and PSUR outputs, class-based update frequencies, PSUR content, and submission or availability routes.
"Throughout the lifetime of the device"
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