Case Study
PMCF Survey for PICC Catheter (USCAN & EU)
A 3-phase PMCF survey approach designed to collect 575 high-quality clinical responses across USCAN and Europe in just 8 weeks to support EU-MDR 745/2017 compliance.
The Client Challenge
- ✔ Legacy PICC device with limited clinical evidence.
- ✔ Required PMCF data for EU MDR 745/2017 compliance.
- ✔ Needed quick, cost-effective, high-quality clinical insights.
- ✔ Mandatory requirement to achieve Rank 4 Clinical Evidence.
Objectives
- ✔ Confirm clinical safety & performance.
- ✔ Identify side effects & previously unknown risks.
- ✔ Assess usability of the PICC device.
- ✔ Address gaps identified in CERs.
Our Approach
- ✔ Phase 1 – CER Gap Analysis.
- ✔ Phase 2 – Sample size, PMCF survey plan, QRE development.
- ✔ Execution via online HCP data collection (APNs, IRs, etc).
- ✔ Phase 3 – Drafting the PMCF Survey Report.
The Scope
- ✔ CER Gap Analysis & PMCF streamlining.
- ✔ 575 retrospective case forms collected.
- ✔ 8-week data collection timeline.
- ✔ Regions: USCAN, Europe & RoW.
Outcome
- Phase 1 Outcomes:
- • Added survey questions to address clinical endpoint gaps.
- • Incorporated latest product insights.
- • Gathered parameters for evaluation of specific indications.
- • Improved assessment of performance endpoints.
- • Collected real-world dwell time & implantation success data.
- Phase 2 Outcomes:
- • PMCF plan aligned with endpoints & acceptance criteria.
- • Justified sample size with strong rationale.
- • Key data collected: age, usage duration, adverse events, indications, off-label use, imaging tech used.
- • Added parameters for detailed indication-level evaluation.
- Phase 3 Outcomes:
- • Primary endpoints successfully met.
- • Low PICC removal rate due to CRBSI.
- • Minimal PICC-related adverse events requiring exchange/removal.
- • Successful submission & acceptance by the Notified Body.
- • No updates required to technical documentation.
- • Device confirmed safe, effective, and compliant under EU-MDR.
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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