PMCF Surveys & Studies
Post-market clinical follow-up evidence for your medical device or IVD under EU MDR and IVDR: from cost-effective PMCF surveys for well-established legacy devices, through to structured PMCF studies when surveys aren't enough and Notified Bodies demand higher-level clinical evidence.
Integrated Clinical and Regulatory Support for Medical Device and IVD Manufacturers
Integrated Clinical and Regulatory Support for Medical Device and IVD Manufacturers
The Medical Device Regulation 2017/745 introduced the term “sufficient clinical data” as a requirement for market approval in Europe. Generating that evidence after a device is on the market is the job of post-market clinical follow-up (PMCF). Depending on your device, its risk class, and the evidence already in your file, the right route is either a PMCF survey or a full PMCF study.
Qserve supports both, as a ladder rather than a choice in isolation. For devices CE-certified under the old Medical Device Directive 93/42/EEC that lack sufficient clinical data, a PMCF survey is an accessible, low-cost entry point. For high-risk devices and IVDs that need higher-level evidence, a structured PMCF study is the fuller engagement.
PMCF Surveys
PMCF Surveys
A PMCF survey is a structured, questionnaire-based method for collecting real-world clinical data from healthcare professionals using a device already on the market. Under EU MDR, it is a cost-effective alternative to a full clinical study for legacy devices that are well established and need additional clinical data.
PMCF survey data collected in EU countries where your device has already been marketed can be used to obtain market access in another country. Qserve has done over 250 PMCF surveys accepted by Notified Bodies to support MDR CE certification.
Our team designs the PMCF survey protocol in compliance with GCP/ISO 14155, ensuring high-quality data collection and analysis. Based on the protocol and your input, we design the questionnaire for the healthcare professionals using your devices. After the plan is finalized, the questionnaire is programmed into an electronic data capturing (EDC) system, followed by survey deployment. Incoming surveys are reviewed and managed. Data is analyzed once all surveys are collected, including statistical analysis to confirm that the study's endpoints are met, and a PMCF survey report is written.
PMCF Survey Services
PMCF Survey Plan Development
We can design a comprehensive PMCF survey protocol and questionnaire tailored to regulatory requirements and clinical objectives, ensuring alignment with the device's intended use and risk profile.
Delivery of Electronic PMCF Survey
We can implement and distribute electronic PMCF surveys using secure digital platforms to collect real-world clinical data from users and healthcare professionals efficiently.
Data Management
We can manage all aspects of PMCF survey data, including secure storage, quality checks, coding, and database maintenance, ensuring data integrity and compliance.
Data Analysis and Reporting
We can analyze collected survey data and produce clear, actionable reports to support clinical evaluation and regulatory submissions.
Statistical Analysis Planning
We can develop a detailed statistical analysis plan (SAP) outlining methodologies and endpoints to ensure robust, compliant data evaluation.
Statistical Analysis Report
We can generate a comprehensive statistical analysis report summarizing methods, results, and interpretations following regulatory expectations.
PMCF Survey Report
We can compile the final PMCF survey report integrating clinical findings, statistical results, and regulatory insights to demonstrate continued safety and performance of the device.
PMCF Studies
PMCF Studies
A PMCF study is a formal post-market clinical investigation that generates Level 1–2 clinical evidence on a device in real-world use. Under the EU MDR 2017/745 and IVDR 2017/746, PMCF studies are mandatory for high-risk devices and IVDs, and are required for Class IIb, Class III, and implantable devices where surveys are insufficient.
Qserve CRO has conducted over 75 PMCF studies across therapeutic areas, from cardio to implantable orthopedic devices, designing scientifically rigorous studies that balance regulatory expectations with operational feasibility while avoiding the costly pitfalls of poor study design or insufficient data collection. We provide PMCF study services from protocol development through final reporting, ensuring your evidence strengthens your Clinical Evaluation Report (CER), supports CE Mark maintenance, and withstands Notified Body scrutiny.
PMCF Study Services
PMCF Strategy & Study Design
Strategies and designs aligned with your device risk class, claims, and residual risks, for proportional and compliant evidence generation.
PMCF Study Protocol Development
Regulator-ready protocols including objectives, endpoints, methodologies, and data collection plans aligned with MDCG guidance.
Regulatory & Ethics Submissions
Submissions to ethics committees and competent authorities, ensuring timely approvals and regulatory alignment.
Site & Stakeholder Management
Identifying and managing clinical sites, investigators, and stakeholders; coordinating start-up, training, and communication.
Data Collection & Management
Structured collection, monitoring, and validation for high-quality, traceable, reliable data.
PMCF Study Reporting
Comprehensive reports supporting your PMS system, clinical evaluation updates, and regulatory submissions.
PMCF Survey Report
We can compile the final PMCF survey report integrating clinical findings, statistical results, and regulatory insights to demonstrate continued safety and performance of the device.
Why PMCF Studies are Critical for MDR & IVDR Compliance
Why PMCF Studies are Critical for MDR & IVDR Compliance
PMCF is a continuous obligation under MDCG 2020-6 and MDCG 2020-13, not a one-off task. For many manufacturers, a structured PMCF study is the only way to generate the ongoing evidence required for conformity assessment. It does this by:
- Closing clinical evidence gaps identified in your CER / Performance Evaluation Report (PER)
- Demonstrating long-term safety and performance for implantable and life-sustaining devices
- Validating clinical claims under real-world conditions of use
- Satisfying Notified Body requirements during MDR/IVDR conformity assessments
- Supporting PSUR and trend reporting with objective, traceable clinical data
- Fulfilling Article 61(4) MDR requirements for Class III and implantable devices lacking sufficient clinical evidence
Key regulatory drivers:
- MDR Article 61 & Annex XIV Part B. PMCF obligations for ongoing clinical evaluation.
- IVDR Annex XIII Part B. Performance evaluation update requirements.
- ISO 14155:2020. Clinical investigation standards for medical devices.
- MDCG 2020-7. PMCF Evaluation Report template and requirements.
Where surveys fit and where studies fit
PMCF surveys reward a structured, well-documented approach from the outset, with clear objectives, timelines, responsibilities, and data collection methods. Poorly planned surveys lead to low response rates, unusable data, regulatory noncompliance, and wasted resources. Digital tools for electronic delivery, automated data validation, and a robust data management system reduce human error and protect the traceability of clinical evidence, while regular monitoring and interim analysis surface issues early enough to fix.
PMCF studies carry the same logic at higher stakes. Ineffective studies produce insufficient data or adverse findings during audits and inspections, and poor design or documentation drives up costs and delays regulatory acceptance. Qserve's structured, practical approach keeps studies operationally feasible: by aligning study objectives with clinical evaluation needs and proactively managing sites and data quality, we generate meaningful post-market evidence while keeping timelines and resources under control.
Where surveys fit and where studies fit
PMCF surveys reward a structured, well-documented approach from the outset, with clear objectives, timelines, responsibilities, and data collection methods. Poorly planned surveys lead to low response rates, unusable data, regulatory noncompliance, and wasted resources. Digital tools for electronic delivery, automated data validation, and a robust data management system reduce human error and protect the traceability of clinical evidence, while regular monitoring and interim analysis surface issues early enough to fix.
PMCF studies carry the same logic at higher stakes. Ineffective studies produce insufficient data or adverse findings during audits and inspections, and poor design or documentation drives up costs and delays regulatory acceptance. Qserve's structured, practical approach keeps studies operationally feasible: by aligning study objectives with clinical evaluation needs and proactively managing sites and data quality, we generate meaningful post-market evidence while keeping timelines and resources under control.
Still have questions? We are here to help.
When should you choose a PMCF survey instead of a PMCF study?
A PMCF survey is suitable for legacy devices that are well established on the market and need additional clinical data cost-effectively. A PMCF study is the route when a device is higher-risk, when Notified Bodies require Level 1–2 evidence, or when surveys cannot close the evidence gaps in your CER.
How can operational inefficiencies in PMCF surveys be avoided?
Clearly defining survey objectives, using electronic tools for data collection, and implementing robust data management and monitoring practices can prevent operational inefficiencies. Proper planning, regular progress tracking, and early issue identification help ensure surveys are conducted smoothly and yield high-quality, usable data.
Are PMCF studies mandatory under EU MDR for all medical devices?
Under EU MDR, PMCF studies are required unless sufficient clinical evidence already exists, particularly for higher-risk and innovative medical devices.
How does Qserve support ISO 14155-compliant clinical trials?
Qserve provides full-service support for clinical trials aligned with ISO 14155, with experts experienced in executing compliant studies and using proven eTMF, CTMS and EDC software to maintain full transparency and documentation.
What role does Qserve play in PMCF activities?
Qserve provides expert guidance across the entire PMCF process. Our experience with regulatory standards, clinical methodologies, and statistical tools helps streamline operations, reduce risks, and ensure compliance.
What are the risks of conducting PMCF surveys without professional support?
Without professional support, PMCF surveys may suffer from poor design, low response rates, data quality issues, and regulatory noncompliance. These problems can lead to delays, rework, or even regulatory penalties. Engaging a consultancy helps mitigate these risks by ensuring the process is scientifically sound and strategically aligned.
Relevant Blogs
Discover the top 5 reasons PMCF plans fail under MDR. Learn how MedTech manufacturers can design audit-ready PMCF strategies for Notified Body review.
Internal PMCF efforts often fall short under MDR. Learn what’s missing and how Qserve CRO helps MedTech manufacturers build audit-ready PMCF strategies.
Struggling with PMCF under EU MDR? Discover what works best for your team: in-house efforts or outsourcing to experts like Qserve.