Post Market Clinical Follow-Up (PMCF) Surveys
Why Companies Choose NAMSA
Panel of HCP and Administrator Participants in Our Global Database
Consultants with Previous EU Notified Body Experience
Native Language In-House Researchers to Conduct In-Depth InterviewsMedical
Case-Specific Surveys and General End-User Surveys
Why PMCF Surveys Matter
Under the EU MDR and IVDR, manufacturers are required to proactively gather and assess clinical data throughout the lifecycle of their devices. PMCF surveys are a powerful way to do just that – by capturing real-world insights directly from healthcare professionals and patients.
Whether you’re preparing for CE marking, responding to a Notified Body, or simply aiming to stay ahead of regulatory expectations, PMCF surveys help you:
- Validate the continued safety and performance of your device
- Identify emerging risks or trends in clinical use
- Support robust clinical evaluation reports
- Build trust with regulators and stakeholders
Types of PMCF Surveys
- Low-Quality Survey (Level 8): Designed to gather insights directly from healthcare professionals based on their overall experience with your device. They focus on topics like product performance, ease of use, safety, and general satisfaction. Think of them as structured feedback forms that help you understand how your device is perceived in real-world clinical settings.
- High-Quality Survey (Level 4): When regulators require more robust clinical evidence, especially for higher-risk devices, this is where high-quality surveys come in. These are more detailed and data-driven, collecting information at the individual patient level. Participating physicians are asked to complete a survey for each patient treated with your device, capturing clinical outcomes, adverse events, and other indication-specific data. But they also provide a much deeper level of insight, exactly the kind of evidence that Notified Bodies expect when reviewing your MDR documentation.
Post-Market Clinical Evidence
Want to learn more about developing your post-market clinical evidence strategy and define the purpose of your study?
End-to-End PMCF Survey Service
At NAMSA, we offer a fully integrated PMCF survey service – from initial strategy to final regulatory reporting. Our approach is designed to be flexible, scalable, and fully aligned with your device’s risk profile and market needs.
1. Strategic Planning & Protocol Development
We begin by working closely with your team to define the right PMCF strategy. Our regulatory consultants and biostatisticians collaborate to:
- Define survey objectives and endpoints
- Calculate statistically sound sample sizes
- Identify the right target population
- Develop a compliant and effective survey protocol
2. Survey Design
Once the strategy is defined, we move into designing the survey itself – this is where your clinical and regulatory goals are translated into a clear, structured questionnaire. Our team works closely with you to develop a scientifically sound and regulator-ready questionnaire that captures exactly the data you need. This includes:
- Relevant questions tailored to your device, indication, and target audience
- Aligning with regulatory expectations, ensuring the questions support your PMCF objectives
- Balancing clinical depth with usability, so the survey is easy for physicians to complete without compromising data quality
- Incorporating screening criteria, especially when targeting specific physician profiles or usage volumes
We host the final survey on a secure, user-friendly online platform, ensuring a smooth experience for participants. Whether it’s a simple perception survey or a complex patient-level data collection, our setup ensures high-quality data capture and compliance from the start.
3. Participant Recruitment
Recruitment is where many surveys fall short. It’s also where we excel. Whether you provide a list of contacts or not, our multilingual research team taps into:
- Our proprietary global database of healthcare professionals
- Direct outreach via different channels
- Custom screeners to identify high-volume, relevant users
- Strategic partnerships with trusted panel providers when needed
We specialize in finding hard-to-reach profiles—even when your product is sold through distributors and you don’t have direct customer access.
4. Data Collection & Biostatistical Analysis
Once the data is in, our biostatistics team takes over. They ensure the data is clean, complete, and analyzed according to regulatory expectations. We generate validated data tables and insights that feed directly into your PMCF documentation.
5. Regulatory Reporting
We deliver a comprehensive PMCF Survey Report, written by NAMSA’s regulatory experts and ready for submission. This report can be seamlessly integrated into your Clinical Evaluation Report (CER).
Why Leading MedTech Companies Trust NAMSA
- NAMSA manages the entire PMCF Survey process, from the earliest stages of PMCF strategy development to the final regulatory report. Our integrated team of regulatory consultants, biostatisticians, clinical researchers, and project managers ensures seamless execution and consistent quality.
- Our PMCF survey reports are built to meet the highest standards of regulatory scrutiny. Developed by NAMSA’s regulatory experts, these reports are designed to integrate seamlessly into your broader MDR documentation. Our long-standing relationships with Notified Bodies mean we understand what they expect and we deliver exactly that.
- With a multilingual research team fluent in over 35 languages and deep connections across hospitals and healthcare systems worldwide, with access to thousands of verified contacts across specialties, NAMSA is equipped to recruit the right participants.
- NAMSA is built for medical devices. We understand the nuances of your industry, the language of regulators, and the expectations of clinical stakeholders.
Frequently Asked Questions (FAQ)
What is a PMCF survey? Why is it important under MDR?
A PMCF (Post-Market Clinical Follow-Up) survey is a method of collecting real-world clinical data after a medical device has been placed on the market. Under the EU MDR and IVDR, manufacturers are required to continuously monitor the safety and performance of their devices. PMCF surveys help fulfill this obligation by gathering structured feedback from healthcare professionals or patients, supporting regulatory compliance and clinical evaluation updates.
What is the difference between a low- quality and a high-quality PMCF survey?
A high-quality PMCF survey is quantitative and collects data at the patient level. Each survey response corresponds to a single patient case, often through retrospective reviews of patient records. These surveys are typically used for devices that are newer to the market, have less existing clinical data, or fall into higher-risk classifications. They aim to measure safety and performance outcomes—such as whether the device improved patient health or caused any adverse events. Because of the nature of the data, ethical approval may be required in some countries, especially if the data is not fully anonymized.
In contrast, a low-quality PMCF survey is qualitative and focuses on the general experience of the end user—either the clinician or the patient. These surveys are more subjective and are used for devices that have been on the market longer and already have a solid base of clinical data. They are ideal for gathering feedback on usability, clarity of instructions, and overall satisfaction. Since they don’t involve direct patient data, they typically do not require ethical approval.
What types of data are typically collected in a PMCF survey?
PMCF surveys are especially useful when there is limited clinical data available, when a device has undergone significant changes, or when it is used in new indications or populations. They are also recommended when Notified Bodies request additional evidence to support the device’s continued safety and performance. Surveys can be a cost-effective way to gather this data without launching a full clinical investigation.
When should a manufacturer consider conducting a PMCF survey?
PMCF surveys are especially useful when there is limited clinical data available, when a device has undergone significant changes, or when it is used in new indications or populations. They are also recommended when notified bodies request additional evidence to support the device’s continued safety and performance. Surveys can be a cost-effective way to gather this data without launching a full clinical investigation.
Meet Our Experts
Explore the depth of our team’s expertise in PMCF Survey.
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Jasper Van de Sande
Senior Business ConsultantView Bio -
Rachel Gibbs, BSc, PhD
Principal Regulatory ConsultantView Bio -
Matt Royle, PhD
Principal Regulatory ConsultantView Bio -
Thomas Miramond, PhD, MSc, M-Eng.
Senior Regulatory ConsultantView Bio -
Jane Arnold-Round, MSc
Senior Principal Consultant, RegulatoryView Bio
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