PMCF surveys, or 'end user' surveys, are a valid method of collecting post-market clinical data. They provide structured questionnaires to healthcare professionals and patients to gain valuable insights on device performance, safety, and user experience in real-world settings.
These are not typical 'marketing' surveys—they are clinical data generation tools designed to meet regulatory requirements under MDR.
Survey design varies based on device risk classification and technology maturity—from general feedback to specific patient-level case studies.
Questions are carefully crafted based on device nature, target population, and specific data gaps identified in your PMCF plan.
Choose the right survey approach based on your device risk classification and data requirements.
Best for: Lower-risk devices and established technologies
Design: Retrospective—asking end-users to recall information about the device and its use
Focus: General user feedback and satisfaction
Data Quality: Moderate—suitable for routine PMCF activities
✓ Quick to deploy
✓ Cost-effective
✓ Broad user reach
PMCF surveys offer unique advantages for post-market data collection, making them an ideal choice in many scenarios.
Manufacturers with direct access to healthcare professionals or patients can efficiently gather targeted feedback without intermediaries.
Perfect for established customer relationships and direct distribution channels
Surveys are flexible and can reach different user groups regardless of size—from small pilot studies to large-scale post-market surveillance.
Adaptable to any sample size and multiple therapeutic areas
Cost-effective in terms of financial commitment and staff resources. Remote data collection reduces burden on patients and research personnel.
Lower costs, faster deployment, minimal patient disruption
Important Note: While general surveys are highly resource-efficient, specific case studies and prospective survey series (Level 4) require more time and financial investment but deliver higher-quality clinical data essential for high-risk device compliance.
Overcome common obstacles in PMCF survey implementation with strategic planning.
Manufacturers struggle to pinpoint exactly what clinical data is missing from their PMCF documentation and how surveys can fill those gaps.
Review your PMCF plan and Clinical Evaluation Report to identify specific data gaps. Align survey objectives and questions directly with these gaps to ensure meaningful data collection.
→ Maintain clear focus to feed appropriate data into your PMCF activities
Post-market data needs change over time as new safety signals emerge or regulatory expectations evolve.
Plan for multiple surveys over time as part of your ongoing PMCF plan development. Conduct periodic gap analyses to identify new data needs and adapt survey design accordingly.
→ Build flexibility into your PMCF strategy for continuous improvement
Low response rates and incomplete or biased responses can compromise the validity of survey data.
Use validated questionnaires, keep surveys concise, and leverage user-friendly ePRO platforms. Implement reminder systems and offer incentives where appropriate to boost response rates.
→ MILO's ePRO platform ensures GDPR compliance and data traceability
Our expert team guides you through every stage of PMCF survey design, implementation, and regulatory compliance.
We review your PMCF plan and Clinical Evaluation Report to identify data gaps, then design scientifically valid surveys tailored to your device and regulatory requirements.
Deploy your surveys on MILO Healthcare's compliant ePRO platform with built-in GDPR compliance, data traceability, and real-time monitoring capabilities.
Our CRA team manages survey distribution, monitors response rates, implements reminder systems, and ensures data quality throughout the collection period.
We analyze survey data, generate comprehensive statistical reports, and integrate findings into your PMCF documentation and Clinical Evaluation Reports.
MILO Healthcare's ePRO platform is purpose-built for medical device clinical data collection with comprehensive compliance and advanced features.
21 CFR Part 11, ICH-GCP, GDPR, HIPAA, ISO 14155:2020 compliant. Audit trails, electronic signatures, and data encryption ensure regulatory readiness.
No coding required. Intuitive interface allows you to design complex surveys with conditional logic, skip patterns, and validated questionnaires (PROMs, FACE-Q).
Live dashboard shows response rates, completion status, and data quality metrics. Identify issues immediately and optimize survey performance.
Supports 20+ languages with automatic translation management. Fully responsive design works seamlessly on desktop, tablet, and mobile devices.
Scientific Board Member & PMCF Survey Expert
"PMCF surveys are a powerful tool when designed correctly. The key is aligning survey questions with specific data gaps identified in your PMCF plan. For high-risk devices, prospective case studies provide the robust clinical evidence needed for regulatory confidence."
— Dr. Marko Lukic
PMCF Survey Design & Implementation
Clinical Evaluation & Gap Analysis
MDR Compliance & Regulatory Strategy
Post-Market Data Collection Methods
