Post-Market Surveillance Plans for MDR and MFDS: Unified Approach

The PMS Convergence Opportunity

EU MDR Article 83-86 and Korean MFDS Notice 2023-104 both require:

• Documented PMS plan covering device lifetime
• Active and reactive surveillance components
• Periodic safety reporting
• Integration with vigilance
• Plan updates based on findings

They differ in:

• Reporting frequency (PSUR annually for MDR; annual report for MFDS)
• Specific data elements required
• Korean-specific patient population analysis
• Notification timelines for action

A unified PMS plan with jurisdiction-specific outputs is operationally efficient.

Unified PMS Plan Architecture

Section 1: Device Scope and Risk Classification

• Devices covered by plan
• EU classification (Class I, IIa, IIb, III)
• Korean classification (Class I, II, III, IV)
• Risk classification rationale

Section 2: Surveillance Methodology

• Active surveillance (proactive data collection)
• Reactive surveillance (complaint and event reporting)
• PMCF (Post-Market Clinical Follow-up) for EU MDR
• Korean-specific surveillance elements

Section 3: Data Sources

Source	Purpose	EU/Korea Coverage
Customer complaints	Reactive	Both
Adverse event reports	Reactive	Both
Distributor feedback	Active + Reactive	Both
Literature monitoring	Active	Both
Regulatory database monitoring (FDA MAUDE, EU Eudamed)	Active	Both
Korean medical literature	Active	Korea-specific
Clinical investigator feedback	Active (PMCF)	EU emphasis
Hospital network data	Active	Korea-specific
User surveys	Active	Both

Section 4: Data Analysis

• Statistical methods
• Trend analysis frequency (quarterly recommended)
• Korean subgroup analysis
• Comparison with benefit-risk profile
• Performance vs intended use

Section 5: Periodic Reports

Report Type	Jurisdiction	Frequency
PSUR (Periodic Safety Update Report)	EU MDR	Annually (Class IIa+), every 2 years (Class I)
PMS Report	EU MDR Class I non-implantable	Updated as needed
Annual Report	Korean MFDS	Annually
Significant Update Report	Both	When trends suggest action

Section 6: Action Triggers

• Performance trends requiring CAPA
• Vigilance thresholds requiring FSCA (Field Safety Corrective Action)
• Regulatory notification triggers
• Plan update triggers

Section 7: Integration with Vigilance

• Adverse event reporting feeds PMS data
• PMS trends inform vigilance thresholds
• Unified investigation workflow
• KLH interface (Korea-specific)

Section 8: Records and Documentation

• PMS data archive (5+ years for Korea, lifecycle + 5 for EU MDR)
• Periodic report archives
• Decision documentation
• Plan revision history

EU MDR vs MFDS — Detailed Comparison

Requirement	EU MDR	Korean MFDS
Plan required	Yes (Article 84)	Yes (Notice 2023-104)
Active surveillance	Yes	Yes
Reactive surveillance	Yes	Yes
PMCF (clinical follow-up)	Yes (most classes)	Recommended (not strictly required for all)
Periodic safety report	PSUR annually	Annual report
Trend reporting	Required	Required
FSCA reporting	Per MDR Article 87-89	Per MFDS Notice 2023-104
Korean population analysis	N/A	Required
Korean clinical literature monitoring	N/A	Recommended
KLH interface	N/A	Required

PSUR vs MFDS Annual Report

Both required annually but differ in detail:

Element	PSUR (EU MDR)	MFDS Annual Report
Sales volume	Yes	Yes
Adverse event summary	Yes (Eudamed reportable)	Yes (Korean events)
Trend analysis	Yes	Yes
Benefit-risk reassessment	Yes (formal)	Yes (less formal)
CAPA summary	Yes	Yes
Regulatory actions taken	Yes	Yes
Korean clinical literature	N/A	Yes
Korean subgroup analysis	N/A	Yes
Submission to	Notified Body / Eudamed	MFDS via KLH

A unified data collection produces both outputs through different reporting templates.

Korean-Specific PMS Elements

Beyond EU MDR alignment, MFDS expects:

Korean Patient Population Analysis

• Performance in Korean patients
• Demographic subgroup analysis (age, gender, comorbidity)
• Comparison with Korean clinical practice guidelines

Korean Healthcare Environment Considerations

• Korean hospital usage patterns
• Korean medical device combination scenarios
• Korean healthcare workflow integration

Korean Regulatory Updates Tracking

• MFDS notice monitoring
• Korean medical device standard updates
• Korean clinical guideline evolution

Operational PMS Workflow

Daily

• Customer complaint intake
• Adverse event triage
• Distributor feedback monitoring

Weekly

• Vigilance event review
• Reportable event determination
• KLH coordination for Korean events

Monthly

• PMS data aggregation
• Trend analysis
• KPI dashboard update

Quarterly

• Comprehensive PMS review
• Action trigger evaluation
• Management review input

Annually

• PSUR generation (EU MDR)
• MFDS annual report generation
• Plan update review
• Benefit-risk reassessment

Cost Estimates

Initial Setup (One-Time)

Component	Cost
Unified PMS plan development	$20K–$45K
Data collection infrastructure	$15K–$50K
Analysis tools and templates	$5K–$15K
Training	$5K–$15K
Total Initial	$45K–$125K

Annual Operating Costs

Component	Cost
Daily/weekly PMS operations	$40K–$100K
Quarterly reviews	$10K–$30K
PSUR generation	$15K–$40K
MFDS annual report generation	$10K–$25K
Tool subscriptions	$5K–$20K
Total Annual	$80K–$215K

Common PMS Pitfalls

Pitfall 1: Separate Plans per Jurisdiction

Maintaining EU MDR PMS plan + MFDS annual reporting separately. Duplicates effort 60%+.

Fix: Unified plan with jurisdiction-specific outputs.

Pitfall 2: Reactive-Only Surveillance

Relying on complaint intake; missing active surveillance.

Fix: Active data collection (literature, distributor feedback, hospital data).

Pitfall 3: No Korean Subgroup Analysis

Korean events analyzed as part of global data; missing Korean-specific patterns.

Fix: Korean subgroup analysis in quarterly reviews and annual reports.

Pitfall 4: PSUR Generated Annually Without Quarterly Foundation

Annual PSUR rushed; quality suffers.

Fix: Quarterly PMS reviews build PSUR throughout year.

Pitfall 5: Vigilance and PMS Disconnected

Vigilance events not feeding PMS analysis.

Fix: Unified investigation workflow; vigilance events automatically inform PMS.

Frequently Asked Questions

Q: Can our distributor handle PMS?

A: Some yes, but most distributors lack capacity. KLH-driven PMS with manufacturer-supplied analysis is more reliable.

Q: How does FDA post-market surveillance fit?

A: FDA MAUDE-based reporting is reactive. FDA does not have PSUR equivalent for most devices. Active surveillance can be unified across FDA, EU MDR, and MFDS.

Q: What if we have many products?

A: Portfolio-level PMS plan with device-specific subsections. Pooled data analysis with device-specific risk assessment.

Q: Does Leanabl provide PMS services?

A: Yes. Leanabl's Vigilance & Post-Market Reporting and Korea Post-Market Operations services include PMS plan development and operations.

Q: How often should we update the PMS plan?

A: Minimum annually. Updates triggered by: significant adverse events, regulatory changes, product changes, plan effectiveness review.

How Leanabl Helps

• Vigilance & Post-Market Reporting — vigilance + PMS operations
• Korea Post-Market Operations — portfolio-wide post-market
• Korea License Maintenance — license maintenance with integrated PMS

Contact Leanabl for unified PMS planning.

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Last updated: 2026-05-15.