PMS Plan Template: Risk-Based Monitoring for Class II/III Devices

What This Template Includes

A complete Post-Market Surveillance (PMS) Plan template structured to satisfy multi-jurisdictional requirements:

• Scope and applicability sections per regulatory framework
• Data sources matrix identifying inputs by source and frequency
• Analysis cadence with trigger thresholds and escalation paths
• Roles and responsibilities mapping including manufacturer-KLH split
• Reporting outputs by regulatory authority and frequency
• Integration with vigilance, complaint handling, and CAPA
• Annual PMS report skeleton (the deliverable that emerges from the plan)
• Korean-specific overlay for MFDS requirements

The template is suitable for Class II and Class III devices, including SaMD/AI-based devices. Class I devices have lighter PMS requirements but can use the same template with reduced scope.

Why a Structured PMS Plan Matters

The Post-Market Surveillance Plan is one of the most-audited and least-functional documents in the typical medical device QMS. A common pattern:

• The plan exists because regulators require it
• It describes data sources that are never actually monitored
• It specifies analysis cadences that are never actually executed
• The annual PMS report is generated retroactively from whatever data happens to be available
• Auditors find this gap and flag it as a CAPA-level non-conformity

The fix is a PMS Plan that is operationally executable — written so that the actual day-to-day work can be performed against it, with measurable evidence that the plan is being followed.

Section 1: Scope and Applicability

The opening section establishes what device(s) the plan covers and which regulatory frameworks apply.

Template content:

• Device(s) covered (by name, model, SKU, UDI-DI)
• Classification per applicable jurisdiction (FDA, EU MDR, MFDS)
• Applicable regulations and standards cited
• Plan effective date and review cycle (typically annual)
• Document control number and version

Practical note: a single PMS Plan can cover a product family if the family shares risk profile and intended use. Distinct product families warrant distinct plans.

Section 2: Data Sources Matrix

The most operationally important section. This matrix identifies where PMS data comes from, how often it is collected, and who is responsible.

A starter matrix structure:

Data Source	Frequency	Owner	Output
Customer complaints (direct)	Daily intake	Customer support	Complaint database
Customer complaints (KLH, Korea)	Daily intake (KLH) → weekly sync to manufacturer	KLH + RA	Korean complaint records
Service and repair data	Monthly	Service operations	Service ticket aggregation
Distributor field reports	Quarterly	Sales operations	Distributor report templates
Hospital/clinic surveys	Annual or post-incident	Clinical affairs	Survey results
Literature surveillance	Monthly	Clinical affairs / RA	Literature scan reports
Competitor adverse event database	Quarterly	RA	Competitor event summary
Social media and online forums	Monthly	Marketing (with RA review)	Social listening summary
Internal audit findings	Per audit	QA	Audit reports
Returns and disposal data	Monthly	Logistics + QA	Returns analysis

Each row in the matrix should have a working data flow. Rows that describe data sources nobody is actually monitoring should be removed; pretending to monitor is worse than admitting non-coverage.

Section 3: Analysis Cadence and Thresholds

Data collection alone is not PMS. The data must be analyzed against pre-defined thresholds with action triggers.

Template content:

• Trend analysis cadence (typical: quarterly trending, annual review)
• Trigger thresholds per metric (e.g., complaint rate exceeding 2× baseline triggers investigation)
• Action escalation per trigger
• Methodology for analysis (control charts, period-over-period, Pareto analysis)

A common failure: trigger thresholds are defined but never actually checked. The fix is to embed threshold checks into the data flow rather than a separate manual analysis step. Many modern complaint-handling systems can automate trend trigger detection.

Sample trigger thresholds:

Metric	Baseline	Investigation Trigger	Escalation Trigger
Complaints per 1,000 units	TBD per device	2× baseline over 30 days	3× baseline OR severity trend
Serious adverse events	TBD	Any single event	Any cluster (3+ in 90 days)
Returns rate	TBD per SKU	1.5× baseline	2× baseline
Field service calls	TBD	1.5× baseline	2× baseline OR safety-related cluster

Section 4: Roles and Responsibilities

Particularly important for foreign-manufactured devices where the KLH/distributor-tied responsibilities differ from the manufacturer's internal structure.

A worked split for a foreign manufacturer with Korean operations:

Activity	Manufacturer	KLH	Distributor
Korean complaint intake	—	Primary	Forwards to KLH
Korean complaint translation	—	Primary	—
Complaint database entry	Primary (global)	Primary (Korean records)	—
Trend analysis	Primary	Provides Korean-specific data	—
Korean vigilance reporting	Provides technical RCA	Files with MFDS	—
Annual PMS report (Korea section)	Primary	Provides input data	—
MFDS audit response	Provides technical content	Primary contact	—

The split is captured in the KLH agreement and should be operationally enforceable. PMS plans that show theoretical responsibility splits without enforceable operational support are typical audit findings.

Section 5: Reporting Outputs

The PMS Plan should specify what reports are produced, to whom, and on what cadence.

Internal outputs:

• Quarterly PMS trend report (internal)
• Annual PMS report (regulatory deliverable)
• Triggered investigation reports (event-driven)

External outputs:

• FDA periodic safety update (where applicable, typically for higher-risk devices)
• EU MDR PSUR (Class IIa: every 2 years, Class IIb/III: annually)
• MFDS annual quantity and adverse event report
• Other jurisdiction-specific reports

The annual PMS report is the most-audited output. Its skeleton is included in the template — typically 20–40 pages covering: scope, data summary, complaint analysis, vigilance summary, trend analysis, conclusions, and CAPA actions taken.

Section 6: Integration with Adjacent Systems

PMS does not operate in isolation. The plan should describe integration with:

• Vigilance — when PMS analysis identifies a reportable event, the handoff to vigilance reporting
• CAPA — when PMS analysis identifies a trend requiring corrective action
• Risk management — when PMS data updates the risk profile, triggering risk file updates
• Design change control — when PMS data identifies a need for design change
• Labeling — when PMS data triggers labeling updates (new warning, refined indication)
• Clinical evaluation — when PMS data feeds into the periodic clinical evaluation update (PCER under EU MDR)

These are typically described as references to other procedures (CAPA procedure, vigilance procedure, etc.) with handoff criteria specified.

Section 7: Korean-Specific Overlay

For Korean-marketed devices, the PMS Plan must address MFDS-specific requirements:

• KLH as primary Korean complaint intake party
• Translation of Korean complaints within defined SLA
• Integration with MFDS Adverse Event Reporting System (formal reporting channel)
• Annual quantity reporting to MFDS
• Korean labeling change tracking
• KGMP surveillance audit support

The Korean overlay is typically 4–6 pages of the full PMS Plan, with cross-references to the main sections.

What Auditors Actually Check

Three sample audit checks for PMS plans:

Check 1: Pull a complaint from 90 days ago. Trace it through the plan. The complaint should appear in the complaint database, be categorized per the plan's taxonomy, contribute to the trend analysis output, and be either closed or escalated per the plan's trigger thresholds. Gaps anywhere in this trace become findings.

Check 2: Pull the most recent quarterly trend analysis. It should exist as a documented output, not just as a planned activity. The methodology described in the plan should match the methodology actually used.

Check 3: Pull the annual PMS report. Compare its content to the plan's specified content. Identify any data source listed in the plan that does not appear in the report — that is evidence the plan describes activities not actually performed.

Three Recommendations

Recommendation 1: Write the plan to match what you actually do. A perfect-looking PMS Plan that does not match operational reality is worse than a leaner plan that does. Be conservative in scope and accurate in execution.

Recommendation 2: Build automated trigger detection. Manual trend-trigger checks are routinely missed. Modern eQMS and complaint-handling systems can automate threshold-based alerts.

Recommendation 3: Treat the KLH as an extension of your PMS team. For Korean operations, the KLH is functionally part of the PMS data collection and reporting infrastructure. Train them, give them access to the relevant procedures, and integrate their data flow into the manufacturer's system.

Download

Download the PMS Plan Template — Word format with editable sections, the data sources matrix, sample trigger thresholds, and the annual PMS report skeleton.

Where Leanabl Plugs In

The PMS and Vigilance services together cover the full post-market surveillance and reporting infrastructure. For consolidated Korean post-market operations including KLH integration, Korea Post-Market Operations bundles the work. License-maintenance touchpoints triggered by PMS findings flow through Korea License Maintenance.