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Solution

PMCF Surveys

PMFC surveys are cost-effective alternatives for clinical studies to obtain post-market clinical data for legacy devices well established on the market and where the EU MDR requires clinical data.

PMCF Surveys

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. For devices that are CE-certified under the Medical Device Directive 93/42/EEC and do not have sufficient clinical data, a post-market clinical follow-up (PMCF) survey is an effective and low-cost solution to gather clinical data as an alternative to doing a PMCF study. PMCF survey data collected in EU countries where your device has been on the market, can be used to obtain market access for your device in another country. 

Qserve has done over 250 PMCF surveys that have been accepted by Notified Bodies to support MDR CE certification. Our team of experts designs the PMCF survey protocol in compliance with the requirements of GCP/ISO 14155, ensuring high-quality data collection and analysis in compliance with regulatory requirements. Based on the protocol and your input, we design the questionnaire to be completed by the healthcare professionals using your devices. After the plan's finalization, the questionnaire will be programmed in an electronic data capturing (EDC) system, followed by the survey deployment. The incoming surveys will be reviewed and managed. Data will be analyzed when all surveys have been collected, including statistical analysis to ensure that the study's endpoints are met, and a PMCF survey report will be written. 

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Satisfied Clients
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MedTech Trainings
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Trainers
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Functional Services

Explore the several ways in which we can help you with a full PMCF survey or only elements:

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 Surveys

Prevent Loss and Operational Inefficiency

To prevent loss and operational inefficiency in PMCF (Post-Market Clinical Follow-up) surveys, it is essential to implement a structured and well-documented approach from the outset. This includes clearly defining objectives timelines, responsibilities, and data collection methods. Poorly planned surveys can lead to:  

- Low response rates 
- Unusable data 
- Regulatory noncompliance 
- Wasted resources.


Leveraging digital tools for electronic survey delivery, automating data validation, and establishing a robust data management system helps reduce human error and ensures the quality and traceability of clinical evidence. Regular monitoring and interim analysis can identify issues early, allowing for timely adjustments and minimizing delays or data loss. 

Ensure your PMCF surveys are strategically planned, efficiently executed, and fully compliant with the support from Qserve’s experts, proven methods, and validated tools. Stay focused on innovation while we help you meet regulatory expectations with confidence.

Talk to Our Experts
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FAQ
Frequently Asked Questions About PMCF Surveys
Still have questions? We are here to help, including with PMCF Surveys.

What is the purpose of a PMCF survey, and why is it important?

PMCF surveys are conducted to gather real-world clinical data on a medical device after it has been approved and marketed. Their primary purpose is to confirm the device’s safety, performance, and benefit-risk profile throughout its lifecycle, in compliance with EU MDR requirements. They are critical for identifying potential issues early and supporting ongoing clinical evaluation and regulatory submissions.

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.

What role does Qserve firm 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, saving time and resources for manufacturers.

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.