PMCF Surveys: Your Guide to MDR Compliance

The process begins with assessing the device’s risk class. For higher-risk devices, such as those in Class III or IIb, high-quality, clinician-led surveys or observational studies are typically required to gather robust clinical performance data. In contrast, devices classified as Class IIa or I may be adequately supported by patient-reported outcomes (PROs) or general usability surveys.

Clinicians are best suited to provide insights into technical performance, adverse events, and clinical outcomes.

Patients, on the other hand, can offer valuable feedback on usability, satisfaction, and symptom relief. In some cases, other users such as caregivers may be relevant, especially for home-use devices.

Next, it’s essential to identify the specific clinical data gaps that remain after the initial evaluation. These may include questions about safety in particular patient populations, long-term performance, off-label use, or issues related to device handling. Understanding these gaps helps define the objectives of the PMCF activity.

High-quality PMCF surveys, classified as level 4 evidence under MDCG 2020-6, are specifically designed to collect robust, prospective, and device-specific clinical data. These surveys are typically completed by clinicians who rely on patient records to ensure accuracy and relevance. For each procedure or use of the device, a single questionnaire is filled out, allowing for consistent data collection across cases.

This approach helps minimize recall bias and supports meaningful statistical subgroup analysis. Due to their methodological rigor, these surveys are particularly suitable for higher-risk medical devices or those with limited pre-existing clinical data, providing valuable insights into real-world performance and safety.

General usability PMCF surveys, categorized as level 8 evidence under MDCG 2020-6, are more recollective in nature and less rigorous compared to higher-tier clinical data sources. These surveys are typically completed by patients or end users, with one questionnaire administered per individual.

Their primary focus is on capturing feedback related to general satisfaction, usability, and the device's handling in real-world settings. Due to their simplicity and user-centered design, these surveys are particularly appropriate for low-risk medical devices or technologies that are already well-established in clinical practice.

Depending on the target population and the specific data needs of the PMCF activity, various formats can be employed to conduct surveys effectively.

Online questionnaires, distributed via email, electronic data capture (EDC) systems or web platforms, offer a convenient and scalable method for reaching a broad audience.

Telephone interviews provide a more personal approach, allowing for clarification and deeper insights, while face-to-face interviews are ideal for gathering detailed feedback in clinical settings.

Clinician-reported outcomes (ClinRO) are particularly valuable for capturing objective clinical observations, whereas patient-reported outcomes (PRO) focus on the patient’s perspective regarding symptoms, satisfaction, and usability.

For remote data collection, electronic PROs (ePROs) offer a flexible and efficient solution, enabling real-time input from users across diverse locations.

To ensure PMCF surveys are both effective and compliant with regulatory expectations, several key design principles should be followed.

Clear Objectives

First, it is essential to define clear objectives that align with the overall PMCF plan, ensuring the survey addresses specific clinical questions or data gaps.

Questionnaire Types

In PMCF activities, two main types are used: validated questionnaires and custom questionnaires, each serving specific regulatory and clinical purposes.

• Validated questionnaires are standardized tools that have undergone scientific testing to ensure reliability and relevance. Recognized by regulatory bodies, they are widely used across therapeutic areas. Their structured format makes them easier to defend during regulatory reviews, especially with Notified Bodies. They support consistent data collection and enable comparisons across studies, strengthening the credibility of PMCF evidence.
• Custom questionnaires, in contrast, are tailored to a device’s specific use, claims, or evidence gaps. These are either newly developed or adapted from existing tools to suit the device’s context. While offering flexibility, they require careful design to ensure usability and regulatory compliance. Their acceptance depends on clear clinical objectives, robust methodology, and justification for not using validated tools. Both formats are valuable in PMCF strategies.

Validated questionnaires offer generalizable data, while custom ones provide targeted insights. The choice should reflect the device’s risk level, existing evidence, and regulatory needs.

Ethical considerations are also critical; surveys must guarantee respondent anonymity and adhere to data protection standards.

Before full deployment, a pilot test should be conducted to identify and resolve any issues with question clarity, format, or response flow.

Also, a thorough statistical approach should be applied in determining the sample size and analytical power of the survey, ensuring that the results are meaningful and representative of the target population.

Training PMCF survey responders is vital to ensure data quality, reliability, and regulatory compliance. Whether clinicians, patients, or other users, their understanding of the survey’s purpose and structure directly affects response accuracy.

Untrained participants may misinterpret questions or skip sections, compromising the survey’s validity. Clinician training should cover documentation practices, clinical interpretation, and ethical standards like confidentiality. For patients or users, clear instructions and support materials help reduce confusion, especially with electronic or remote formats.

Trained responders better understand their role in post-market surveillance and provide more meaningful input, especially when surveys address clinical data gaps or support regulatory submissions. Investing in training improves data quality and strengthens the credibility of the PMCF process.

Data analysis is essential to the success and regulatory relevance of PMCF surveys. While collecting post-market clinical data is important, its value depends on how well it’s processed and interpreted. Without solid analysis, even well-designed surveys may fail to show a device’s ongoing safety and performance.

Proper analysis ensures results are statistically valid, representative, and capable of identifying trends or risks. It helps detect patterns like off-label use or adverse events, and subgroup analysis reveals performance differences across demographics or settings.

Regulators expect PMCF data to be analyzed with scientific rigor, including sample size calculations, bias control, and clear documentation. This supports MDR compliance and strengthens the credibility of clinical evaluations. Ultimately, strong data analysis turns raw responses into meaningful evidence, guiding product improvements, risk assessments, and continued conformity with safety and performance standards.

• Our QbD Regulatory team ensures your Technical Documentation is complete and compliant, covering risk management and PMS in line with MDR.

• QbD Clinical Medical Writing identifies gaps in clinical evidence and addresses them through literature review and analysis, delivering precise Clinical Evaluation Plans and Reports.

• When surveys are the preferred PMCF activity, we help define the right format, target population, and objectives. We create tailored PMCF Plans and Reports that feed into updated CERs, ensuring continued compliance.
• QbD Clinical Operations manages PMCF surveys end-to-end—from design and deployment to data collection and analysis. Whether you need coaching, review, or full-service support, QbD Clinical is your trusted partner for scientifically sound, regulator-ready PMCF surveys.