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EU Medical Device Regulation (MDR) 2017/745 PMS Plan Template

Build a PMS plan you can execute (not just file).

This outline focuses on operational details: data sources, owners, thresholds, actions, and report outputs.

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Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

A PMS plan only helps if it describes a working system. Use this template as a copy-ready outline and fill it with specifics: who collects what data, how signals are detected, what thresholds trigger CAPA or vigilance actions, and how outputs (PMS report/PSUR) are produced and reviewed.

Section 1

PMS plan template (Annex III-aligned structure)

Use this structure for one device family and intended purpose. Keep a change log and link updates to change control and PMS signals.

Tip: put detailed evidence tables (data source definitions, KPIs, thresholds) in annexes so the main PMS plan stays readable.

1) Scope: device family, intended purpose, variants/accessories, markets, user groups, use environments.
2) PMS objectives: what safety/performance questions you must answer post-market; residual uncertainties from CER and risk management.
3) PMS data sources: complaints, service, returns, user feedback, registries, literature monitoring, supplier data, cybersecurity inputs (if relevant).
4) Data collection and quality: definitions, coding, de-duplication, minimum fields, privacy/data governance constraints.
5) Signal detection and trending: thresholds, statistical methods (where appropriate), review cadence, escalation criteria.
6) Analysis and actions: CAPA triggers, risk management updates, labeling/IFU updates, clinical evaluation updates, design changes.
7) Vigilance interface: reportability decision workflow, serious incident handling, FSCA and field safety notice workflows.
8) Reporting outputs: PMS report/PSUR responsibilities, cadence, and management review inputs.
9) Roles and responsibilities: owners, deputies, review boards, escalation pathways, and training requirements.
10) Effectiveness checks and audits: how you test the PMS system and track CAPA effectiveness.

Recommended next step

Keep EU Medical Device Regulation (MDR) 2017/745 PMS Plan Template in one governed evidence system

SSOT can take EU Medical Device Regulation (MDR) 2017/745 PMS Plan Template from reusing this material inside a governed evidence system to a reusable workflow inside Sorena. Teams working on EU Medical Device Regulation (MDR) 2017/745 can keep owners, evidence, and next steps aligned without copying this guide into separate documents.

Evidence system

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Start from EU Medical Device Regulation (MDR) 2017/745 PMS Plan Template and keep documents, evidence, and control records in one governed system.

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Section 2

Metrics and KPIs (examples that are actually usable)

Pick metrics you can collect reliably. A smaller set of high-quality indicators beats a long list of noisy metrics.

Control: define thresholds and the required action for each threshold (not just the metric).

Complaint rate per 1,000 uses/units and by failure mode; severity distribution and time-to-resolution.
Serious incident assessment turnaround time; vigilance submission timeliness; FSCA execution time and effectiveness rate.
Trend signals: increasing frequency of a specific harm scenario or near-miss; software anomaly rates where clinically relevant.
CAPA effectiveness: recurrence rate after corrective action; verification/validation completion time for fixes.
Data quality: missing-field rate in complaint records; linkage rate from complaints to UDI/device variant.

Section 3

Minimum artifacts to attach (your audit-ready PMS pack)

Auditors look for records that prove the system is running. Attach or link to these artifacts and keep them current.

If you can't retrieve them quickly, build retrieval first.

PMS plan (this document) + change log and approval history.
Complaint handling SOP + coding taxonomy and training records.
Signal/trend log + meeting minutes for review boards and escalations.
Vigilance log + reportability decisions + FSCA records and effectiveness checks.
PSUR/PMS report outputs + management review records + CAPA effectiveness evidence.

Primary sources