Case Study
End-to-End EU-MDR Support for a Class III Legacy Medical Device
PMCF survey-based solution with 500+ data points collected across USCAN & Europe in just 8 weeks.
Client Challenge / Objective
- ✔ Capture PMCF data for legacy PICC device with limited clinical evidence.
- ✔ Ensure EU MDR 745/2017 compliance quickly and cost-effectively.
- ✔ Achieve mandatory Rank 4 Clinical Evidence.
Scope
- ✔ Streamlining PMCF plan + survey protocol
- ✔ Sample size: 575 retrospective case forms
- ✔ Timeline: 8 weeks
- ✔ Regions: USCAN & Europe
Outcome
- ✔ Achieved Level 4 Clinical Data ranking
- ✔ Full regulatory + ISO 14155 + GDPR alignment
- ✔ Major cost & timeline savings vs. alternate PMCF methods
Cetas Healthcare’s Comprehensive PMCF Solution
CER Gap Analysis
- • Review CER for gaps in clinical data
- • Identify clinical endpoints (Primary & Secondary)
- • Literature review for inadequacy
- • SOTA review for benchmark comparison
- • Map clinical data sources & indications
- • Map adverse events as per IFU
Draft PMCF Survey Plan
- • Define clinical outcomes & sample size
- • Prepare PMCF survey questions
PMCF Survey Execution
- • Design questionnaire with best practices
- • Program survey & finalize with client
- • Launch survey on EDC platform
- • Collect raw clinical data including outcomes & AEs
PMCF Survey Report
- • Deep clinical data analysis
- • Graphical representation of outcomes & AEs
- • Map indications against each product
- • Submit draft report to client
CER Remediation
- • Prepare updated CER
- • Ensure full regulatory compliance
PMSR / PSUR
- • Update PMSR/PSUR for submission
- • Provide supporting documentation
NB Liaison
- • Support interim PMCF report for NB
- • Respond to NB clinical/biological inquiries
CER Gap Analysis Overview
Gaps Identified
- 1. Gaps in clinical endpoints & acceptance criteria
- 2. Brief SOTA (State of the Art) section
- 3. Insufficient data for several indications
- 4. Inadequate performance endpoint measurement
- 5. Lack of literature supporting dwell time & treatment completion
Our Solution
- ✔ Additional clinical data collected via PMCF survey
- ✔ Enhanced SOTA insights using updated survey data
- ✔ Additional parameters for indication-level evaluation
- ✔ Inputs for better performance endpoint assessment
- ✔ Real-world dwell time & success metrics gathered
Speak with our PMCF team
Get a Rapid Assessment Of Your CER/PMCF Needs
Cetas Healthcare is a global leader in conducting ISO 14155-compliant Post-Market Clinical Follow-up (PMCF) surveys for MedTech devices. We specialize in designing and managing robust PMCF studies that capture real-world clinical evidence for Class II and III devices. To date, we’ve handled 25,000+ patient case forms, enabling clients to strengthen CE certification submissions and maintain full compliance with EU MDR requirements. By combining rigorous clinical research with actionable insights, we help MedTech companies continuously monitor device performance and enhance patient safety.
Contact Us: communication@cetas-healthcare.com
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