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Since the implementation of the Medical Device Regulation (2017/745) (MDR) in Europe, manufacturers must proactively monitor the safety and performance of their medical devices throughout their entire lifecycle. Post-Market Clinical Follow-Up (PMCF) surveys have become widely accepted as an essential component of PMCF data collection. These surveys are a valuable tool for gathering real-world data about a device’s safety and performance.
Significance of PMCF surveys
Level 4 & 8 Evidence Levels
The Medical Device Co-ordination Group (MDCG) 2020-6 guidance document ranks data collection methods for legacy devices based on the level of evidence they can provide, with 1 being the highest, and 12 being the lowest. Between clinical investigations, registries, and other non-clinical sources of data, PMCF surveys fall into two categories–with high-quality user surveys assigned an evidence level of 4 and general usability surveys assigned a lower evidence level of 8. PMCF surveys typically fall under Level 4 Evidence as long as they are properly designed and conducted. A certain level of adherence to ISO 14155 is highly recommended.
Risk Classification & Supplementing Clinical Data
Higher-risk devices with limited clinical data require more extensive evidence. In a PMCF strategy, high-quality surveys could be used to supplement clinical findings with real-world evidence, especially when data gaps exist (e.g., specific age groups or device variants).
Statistical Power
During the set-up phase, biostatistical analysis will define robust sample sizes to enable sufficient statistical power. High-quality surveys allow for robust subgroup analysis because you can explore variations across demographics, medical conditions, or device usage patterns. This enables researchers to detect trends, rare adverse events, or subgroup impacts more effectively.
When to Use PMCF Surveys
PMCF surveys are typically used after a device has been marketed. They are particularly useful when:
- There’s a need to confirm the safety and performance of the device in a real-world setting.
- There’s a need to identify rare complications or long-term performance issues that were not detected in pre-market clinical trials.
- The device has been modified in a way that could impact its safety or performance.
- The device is being used in a new patient population or for a new indication.
Why Use PMCF Surveys
PMCF surveys offer several benefits:
- Real-World Evidence: They provide real-world evidence that is essential for assessing a device’s safety and performance over its entire lifecycle.
- Regulatory Compliance: They help to fulfill the requirements under the EU Medical Device Regulation (MDR) and other regulatory frameworks.
- Cost-Effectiveness: Surveys offer a cost-effective method for collecting data. Unlike resource-intensive clinical trials, surveys can provide valuable insights without cutting into your budgets too much. Typically, high quality surveys are only a fraction of a clinical trial/registry budget. This allows manufacturers to save on budget and conduct other clinical programs.
- Time Efficiency: High-quality surveys are swift in execution. Unlike lengthy clinical trials, which can span years, surveys yield results promptly–allowing for timely decision-making. Typically, collecting data through high-quality surveys can be achieved in a matter weeks, or at most, months.
- Global Reach: Online surveys transcend geographical boundaries. Manufacturers can tap into a diverse global population, enhancing the representativeness of findings by including geographies, sub-populations, or other characteristics.
- Versatility: Surveys can collect a variety of data, including information on device performance, usage, potential safety issues and patient satisfaction.
How to Use PMCF Surveys
Here are some key steps to using PMCF surveys effectively:
Design the Survey: The survey should be designed to collect relevant data about the device’s safety and performance. This includes adverse events, device deficiencies, and patient-reported outcome measures.
Tips for Designing High-Quality Level 4 PMCF Surveys:
- Define Clear Objectives: Before you start designing your survey, have a clear understanding of what you want to achieve. This will guide the type of questions you ask and the data you collect.
- Know Your Audience: Understand who will be responding to your survey. This will help you tailor your questions to be relevant and understandable to your audience.
- Keep it Simple: Make sure your questions are simple, clear, and concise. Avoid using complex language that might confuse respondents.
- Question Types: Closed-ended questions can be designed to score values, items from lists, percentages, and many other measurements. Design the questions correctly so it will fill the data gaps but will not result in additional questions.
- Ensure Anonymity: If possible, ensure that your survey is fully anonymous. This will allow you to collect clinical data as ethically as possible.
- Pilot Test Your Survey: Before rolling out your survey, conduct a pilot test with a small group of respondents. This can help you identify any issues or confusion with the survey questions.
Conduct the Survey: The survey can be conducted through various methods, such as online questionnaires, telephone interviews, or face-to-face interviews. The choice of method will depend on the nature of the data to be collected.
Analyze the Data: The data collected through the survey should be analyzed to draw meaningful conclusions. This includes statistical analysis of the data and interpretation of the results.
Report the Findings: The findings of the PMCF survey should be reported in a clear and transparent manner. This includes documenting the methods used, the results obtained, and the conclusions drawn. Reports also need to meet Notified Body expectations.
How NAMSA Can Help
Surveys are new activities PMCF introduced with MDR. They provide real-world evidence, complement clinical findings, and facilitate global insights. Whether assessing safety, performance, or patient satisfaction, surveys also support informed decision-making.
At NAMSA, we understand the importance of PMCF and the role it plays in maintaining regulatory compliance. Our team of clinical and regulatory experts can provide comprehensive support in the design, implementation, recruitment, and analysis of your PMCF surveys.
Whether you need assistance in designing a robust PMCF survey, recruiting the right participants, or interpreting the survey results, NAMSA is here to help. Our goal is to provide you with the tools and support you need to successfully navigate the PMCF process.