PMCF Support
PMCF Evidence Pathways Designed for Reliable Data Collection, Statistical Validity, and Regulatory Alignment
PMCF Support Services Overview
We support medical device companies in designing, executing, and documenting PMCF activities fully aligned with MDR Annex XIV Part B, MDCG 2020-7 and MDCG 2020-8.
PMCF Plan
PMCF Evaluation Report
PMCF Survey Plan
PMCF Survey Report
PMCF Plan Development
Fully aligned with MDR Annex XIV Part B
Device-specific and risk-based
Integrated with CER, PMS, and Risk Management outputs
Our PMCF Plan Process
Review of intended purpose, clinical claims, and risk profile
Identification of evidence gaps from CER/PMS data
Definition of PMCF objectives and endpoints
Selection of PMCF activities (registries, clinical data collection, user surveys, case series, device tracking, etc.)
Study design, methodology & sample considerations
Data collection, responsibilities, and timelines
Statistical and analysis framework
Linkage to CER, PMS, and RMF updates
Outcome
A complete, audit-ready PMCF Plan that justifies the chosen PMCF pathway and details how post-market evidence will be generated and evaluated.
PMCF Evaluation Report (PMCF ER)
Comprehensive review of PMCF data collected via surveys, clinical follow-ups, case series, registries, and other sources
Analysis of device safety and performance against PMCF endpoints
Assessment of residual risks, adverse events, complications, and complaint trends
Verification of benefit–risk profile and comparison with CER conclusions
Recommendations for updates to PMSR/PSUR, CER, and risk management documentation
Outcome
A defensible PMCF ER that demonstrates continued safety, performance, and clinical benefit.
PMCF User Surveys
We design and implement PMCF surveys based on device risk, novelty, clinical uncertainties, and Notified Body expectations.
Rank 4 Surveys - User Feedback Surveys
For higher-risk, implantable devices where data to support clinical outcomes are required.
PMCF Survey Plan with clearly defined clinical endpoint
Detailed questionnaire aligned with intended purpose, clinical claims, and specific anatomy/indication
Bias mitigation strategies
Data capture structured for statistical analysis
Subgroup analysis (e.g., indication, anatomy, device size, patient demographics)
PMCF Survey Report with evidence mapped to PMCF objectives and CER claims
Outcome
Implantables, orthopedic anchors, complex surgical devices, devices with performance uncertainties.
Rank 8 Surveys - Patient/User Experience Surveys
Suitable for low-risk devices, accessories, or technologies with well-established performance.
Post-use feedback from end-users or patients
Capturing safety, handling, satisfaction, and perceived outcomes
PMCF Survey Design & Methodology Offerings
PMCF Survey Plan Development
Objectives, rationale, methodology, endpoints, safety indicators, and sample size logic.
Survey Questionnaire Development
Structured, validated questionnaires designed to generate clinically meaningful evidence.
Sample Size & Statistical Plan
Statistical justification for Rank 4/8 surveys and creation of comprehensive Statistical Analysis Plan.
HCP & Patient Recruitment Strategy
Region, indication, and specialty-specific recruitment tailored to device risk and intended population.
PMCF Survey Execution & Reporting Offerings
Survey Deployment & Data Collection
Secure, compliant platforms with traceable responses.
Data Cleaning & Statistical Analysis
Descriptive statistics, cross-tabulation, trend detection, and safety signal assessment.
PMCF Evaluation Report Development
Integration of survey outcomes with PMS, risk management, and CER.
NB Query Support
Justification of methodology, survey representativeness, and sample robustness.
PMCF Survey Key Deliverables
PMCF Survey Plan
Rank 4 & Rank 8 Survey Questionnaires
Sample Size & Statistical Plan
Data Collection Logs
PMCF Evaluation Report
PMS / CER Integration Summary
Why Choose Us for PMCF Support?
Deep expertise in PMS, CER, PMCF, and SLR
Strong understanding of Notified Body expectations (TÜV, BSI, DEKRA, DNV, GMED)
Experience across Class I–III and implantable devices
Fully traceable, audit-ready documentation
Fast turnaround without compromising quality
Ability to manage multiple anatomies, indications, and device families
Have a Business Enquiry?
Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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