Case Study
PMCF Survey for Venous Access Port (USCAN & EU)
A structured 3-phase PMCF program designed to collect 200 high-quality clinical case forms across USCAN, Europe, and RoW in just 6 weeks for EU-MDR 745/2017 compliance.
The Client Challenge
- ✔ Legacy Venous Access Port with limited clinical evidence.
- ✔ Required PMCF data to meet EU MDR 745/2017 standards.
- ✔ Needed fast, cost-efficient, high-quality clinical insights.
- ✔ Mandatory requirement to achieve Rank 4 clinical evidence.
Objectives
- ✔ Confirm clinical safety & performance of the port device.
- ✔ Identify side effects & previously unknown risks.
- ✔ Assess device usability in real-world conditions.
- ✔ Address gaps identified in the Clinical Evaluation Reports (CERs).
Our Approach
- ✔ Phase 1 – CER Gap Analysis.
- ✔ Phase 2 – Sample size, PMCF plan, QRE development.
- ✔ Online clinical data collection from HCPs across USCAN & EU.
- ✔ Phase 3 – Development of PMCF Survey Report.
The Scope
- ✔ CER gap analysis & PMCF plan alignment.
- ✔ Collection of 200 retrospective patient case forms.
- ✔ 6-week accelerated data collection timeline.
- ✔ Coverage across USCAN, Europe, and RoW.
Outcome
- Phase 1 Outcomes:
- • Established clear clinical endpoints & acceptance criteria.
- • Validated endpoints supporting the intended purpose.
- • Strengthened literature evidence for performance & safety.
- • Added comprehensive state-of-the-art and benchmark device review.
- Phase 2 Outcomes:
- • PMCF plan fully aligned with endpoints & criteria.
- • Justified sample size with strong statistical rationale.
- • Collected key clinical data: patient age, dwell time, adverse events, off-label use, indications, imaging methods.
- • Enhanced evaluation of specific indications through added parameters.
- Phase 3 Outcomes:
- • Primary endpoint achieved (long-term vascular access, etc.).
- • Secondary endpoints achieved (low port removal rate, minimal DVT/VTE events).
- • PMCF Report accepted by the Notified Body.
- • No updates needed to technical documentation.
- • Device confirmed compliant, safe, stable & EU-MDR aligned.
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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