Post-Market Surveillance (PMS/PMCF)

Available Plans

Pro / Max / CRO

Overview

EU MDR mandates comprehensive post-market surveillance. Reguverse provides complete PMS workflows from planning to reporting.

Available Workflows

Workflow	Description	Output
PMS Plan	Post-market surveillance planning	PMS Plan document
PMCF Plan	Post-market clinical follow-up planning	PMCF Plan document
CE Update	Periodic clinical evaluation update	Updated CER
PMCF Report	PMCF evaluation report	PMCF Report
PSUR	Periodic Safety Update Report	PSUR document

PMS Plan

Defines post-market monitoring strategy including adverse event monitoring, FSCA procedures, trend reporting, and complaint handling.

PMCF Plan

Defines post-market clinical data collection strategy: objectives, data sources, analysis methods, endpoints, and timelines.

CE Update

Periodic clinical evaluation updates incorporating latest safety and performance data, comparing against previous literature pools, and updating benefit-risk conclusions.

PMCF Report

Evaluation report based on PMCF activities: data collection summary, clinical data analysis, safety conclusions, and recommendations.

PSUR

Periodic safety update reports as required by EU MDR: safety data summary, adverse event analysis, corrective actions, and benefit-risk reassessment.

Regulatory Requirements

• Class IIa and above: PSUR at least annually
• Class III and implants: PSUR submitted to EUDAMED
• Class I: PMS report as needed (not PSUR)