“Our clinical strategy expertise and risk-based approach ensures we guide you to the PMCF activity that fits your business in the most feasible way, taking into account your company’s risk tolerance as well.”
—Niki Spaniel, Senior Consultant
CMD MedTech provides comprehensive post-market clinical follow-up (PMCF) solutions, including PMCF strategies, PMCF Plans, PMCF retrospective chart review study, and PMCF reporting services to help medical device manufacturers navigate the EU Medical Device Regulation (MDR). Under MDR, medical device manufacturers are required to maintain continuous oversight of their products through post-market surveillance (PMS), including PMCF. Unlike the Medical Device Directive (MDD), which had more lenient requirements, MDR mandates a continuous proactive and systematic approach to collecting real-world clinical data to support your device’s safety and performance throughout the lifetime of the device.
Why Choose CMD MedTech as Your PMCF Consultant
- Clinical strategy expertise that guides you to the most appropriate PMCF activities
- Right-sized approach that fits your business needs while meeting regulatory requirements
- Understanding of notified body expectations regarding the quality of clinical evidence
- Experience with both FDA and EU MDR pathways, helping align global strategies that will serve multiple markets.
- Ability to analyze existing clinical data that companies may not realize can be leveraged
- Strategic guidance that balances your company’s risk tolerance with regulatory requirements
- Experience transitioning devices from MDD to MDR compliance
- PMCF Retrospective Chart Review Study Activities are a cost-conscious solution to high-quality clinical data without the burden of an expensive and time-consuming prospective clinical study.
- Our PMCF Study Activities are GDPR compliant and can cover many regions around the world.
UNDERSTANDING POST-MARKET CLINICAL FOLLOW-UP REQUIREMENTS
The PMCF process is proactive, requiring manufacturers to collect clinical data on their devices in real-world settings after market placement. This approach recognizes that clinical studies are controlled environments where devices tend to perform better, while complaints are typically underreported.
Under MDR, every device must have a PMCF plan, even if you determine no specific PMCF activities are needed (in which case you must provide justification). PMCF is the proactive part of the broader post-market surveillance framework, which works alongside clinical evaluation and risk management processes.
The goal of PMCF is to:
PMCF Planning Process
1. EVALUATE CLINICAL EVIDENCE
• Understand and assess existing clinical evidence
• Gather clinical data on the device
• Incorporate inputs from clinical, post-market, and risk management teams
• Compare to state-of-the-art data and performance and safety objectives
2. REVIEW AVAILABLE DATA
• Review existing data with a cross-functional team
• Determine if data is sufficient
• Verify clinical benefits, objectives, and claims are supported
• Assess whether it makes sense to market the product under MDR
3. DEVELOP PMCF STRATEGY
• Create a comprehensive PMCF strategy
• Develop PMCF plan in line with MDCG 2020-7
• Look to MEDDEV 2.12-2 for additional insight
• Determine appropriate timing for PMCF activities
4. IMPLEMENTATION SUPPORT
• Guidance on executing selected PMCF activities
• PMCF Retrospective Chart Review Survey Activity subject matter experts
• Facilitation of data collection and analysis
• Documentation preparation for PMCF Evaluation Report and to update the CER
• Continuous PMCF support throughout the lifetime of the device
Options for PMCF Activities
Clinical Literature
Reviews of published research on your device or similar devices to demonstrate state-of-the-art standards, though not clinical data under the MDR, can support well-established technologies.
User Feedback
Collection of general real-world performance data through customer surveys, focus groups, expert user input, and observations during training programs to supplement other clinical evidence sources. (Not generally considered high-quality data).
Database/Registries
Utilization of device or implant registries and hospital or national databases to provide high-quality longitudinal evidence particularly valuable for implantable devices and complex medical equipment.
Retrospective Chart Review Surveys
As a PMCF consultant, our specialized approach using healthcare provider panel-based high-quality surveys to collect patient-specific clinical outcomes data serves as a strong, cost-effective alternative to full clinical studies.
Prospective Clinical Study
The highest quality evidence recognized by notified bodies, ranging from randomized controlled trials to investigator-sponsored research, necessary for high-risk devices or novel technologies where other evidence types are insufficient.
FREQUENTLY ASKED QUESTIONS ABOUT PMCF SERVICES
This is often the first question manufacturers ask. The answer depends on your device’s risk classification, how long it’s been on the market, available clinical evidence, and whether you’ve relied on equivalence claims in the past. We can review your current documentation to determine if additional data collection is needed and what PMCF activities would be most appropriate.
Options range from focused literature reviews to full clinical studies, with retrospective chart review surveys offering a strong middle ground. The appropriate activity depends on your device risk class, legacy status, well-established technology perspective, available clinical data, and business considerations. We can help you select activities that will be perceived favorably by notified bodies while remaining feasible for your organization.
Notified bodies assess clinical evidence quality on a scale, with prospective controlled clinical studies ranking highest and general surveys or limited uncontrolled studies ranking lower. Our retrospective chart review methodology typically achieves a higher quality level than many alternatives, enhancing the likelihood of regulatory acceptance.
Many companies design primarily for the US market, then later seek EU market access. This approach can create gaps in required documentation for MDR compliance. If your device is already on the US market, we can help you collect appropriate data that will support your EU submission, potentially avoiding the need for additional clinical studies.
The frequency depends on your device’s risk classification. Class III and implantable devices require annual updates, while lower-risk devices may have less frequent requirements. Your PMCF plan for medical devices should leverage your CER update frequency requirements or establish a schedule that accounts for both regulatory requirements and business feasibility.