PMCF Under MDR: When is a Healthcare Professional Survey Approach Justifiable?

EU Medical Device Regulation (MDR) 2017/745 implementation has increased expectations for clinical evidence. Manufacturers must now generate and evaluate clinical data throughout the entire lifecycle of a medical device, particularly through Post-Market Clinical Follow-up (PMCF).

PMCF is defined in Annex XIV Part B of the MDR as a continuous process that proactively collects and evaluates clinical data once a device is placed on the market. Its objectives include:

• Confirming long-term safety and clinical performance
• Identifying previously unknown risks or complications
• Monitoring real-world device use

Ensuring that the benefit–risk profile remains favorable over time

Under MDR, PMCF is expected for most devices. If a manufacturer determines that PMCF is not required, a clear and scientifically justified rationale must be provided. As a result, manufacturers must adopt structured and risk-based PMCF approaches to maintain adequate clinical evidence throughout the device lifecycle.

For organizations managing large device portfolios – particularly those that include legacy products, developing a proportionate PMCF strategy has become a significant regulatory challenge. While clinical investigations, registries, and observational studies remain the most robust sources of clinical evidence, they may not always be proportionate or operationally feasible for every device. Consequently, manufacturers are increasingly considering Healthcare Professional (HCP) surveys as part of their PMCF approach. However, Notified Bodies often scrutinize whether survey-based PMCF methods are scientifically justified and capable of generating meaningful clinical evidence. Therefore, it is important for manufacturers to clearly understand where surveys fit within the overall PMCF evidence hierarchy.

Where HCP Surveys Fit in the Evidence Hierarchy

Although surveys are not explicitly referenced in MDR, regulatory guidance such as MDCG 2020-6 Guidance on PMCF recognizes them as a potential source of post-market clinical data. Appendix III of this guidance outlines a hierarchy of post-market evidence sources based on their evidentiary strength. Within this framework, high-quality PMCF surveys are categorized as Level 4 evidence, while general user feedback surveys are considered Level 8 evidence.

Level 4 surveys are intended to capture structured clinical observations from healthcare professionals. These surveys typically include clearly defined objectives, case-level reporting of patient outcomes, and predefined sampling strategies designed to minimize bias. When clinicians report outcomes linked to individual patient cases rather than general experience, the resulting dataset can approximate real-world observational evidence.

In contrast, Level 8 surveys generally collect broad retrospective feedback related to usability, device handling, or perceived effectiveness. Because these surveys rely largely on subjective recollection rather than structured clinical observations, their evidentiary value is limited, and they are typically suitable only for low-risk or well-established devices.

When HCP Surveys Are a Justifiable PMCF Tool

1. Bridging Evidence Gaps for Legacy Devices

   One of the most common applications of HCP surveys is for legacy devices transitioning to the requirements of EU MDR. Many long-marketed technologies were originally approved with limited prospective clinical data. Under MDR, manufacturers must now demonstrate sufficient clinical evidence to support continued market access. In such cases, surveys can help confirm ongoing safety and performance while complementing existing literature and vigilance data. For well-established technologies with extensive clinical use, surveys can provide valuable real-world confirmation of the device’s benefit–risk profile.

2. Proportionate PMCF for Low-to-Moderate Risk Devices

   For Class I, Class IIa, and certain Class IIb devices, the primary objective of PMCF is often to capture real-world clinical experience rather than generate detailed comparative outcomes. Examples include surgical accessories, reusable instruments, and ancillary diagnostic tools. In these situations, surveys can capture clinician observations related to device handling, frequency of use, and any observed complications. When interpreted alongside other post-market data sources such as complaints, vigilance reports, and literature reviews – survey data can contribute to a proportionate PMCF strategy aligned with the device’s risk profile.

3. Understanding Real-World Device Use

   Surveys are particularly useful for understanding how devices are actually used in clinical practice. Real-world usage may differ from the controlled environments described in clinical studies or instructions for use. Structured questionnaires can help identify off-label use patterns, variations in clinical techniques, device handling challenges, and potential training gaps. These insights can inform usability improvements and support updates to risk management documentation.

4. Investigating Early Post-Market Signals

   Surveys can also play a role in early signal detection within PMCF activities. Manufacturers may deploy targeted surveys to collect feedback on device modifications, updated indications, or newly introduced features. If survey responses indicate potential concerns, manufacturers can escalate their PMCF strategy by initiating more robust studies, such as observational investigations or clinical registries.

Despite these advantages, surveys rarely meet regulatory expectations for higher-risk devices or novel technologies. Devices introducing new mechanisms of action, materials, or indications typically require prospective clinical investigations. Similarly, Class III and implantable devices are expected to demonstrate a high level of clinical evidence under Article 61(1) of MDR, often through structured clinical studies or registries that capture defined clinical endpoints.

While surveys may still provide supportive real-world insights in these contexts, they generally cannot replace formal clinical investigations. Furthermore, if complaints, vigilance reports, or published literature suggest potential safety concerns, survey data alone is unlikely to provide sufficient evidence to fully assess the associated risks.

Designing Surveys That Withstand Regulatory Scrutiny

To ensure regulatory acceptance, PMCF surveys must be scientifically robust and clearly justified. Key elements include:

• Clearly defined clinical objectives
• Respondents with relevant clinical experience using the device
• Structured questionnaires capturing meaningful clinical observations
• Adequate sample size and sampling methodology
• Integration of survey findings with other PMS vigilance, and literature data
• Control potential bias including methodological bias
• Integration between survey findings and Risk Management activities

It is suggested that the survey data should be analyzed alongside complaints, vigilance reports, literature reviews, and trend analyses. This integrated evaluation strengthens the overall clinical evidence package supporting the device.

Emerging Regulatory Perspectives

Regulators increasingly acknowledge that generating robust clinical evidence can be challenging for certain device categories, particularly those intended for rare conditions, niche indications, or limited patient populations. Guidance such as MDCG 2024-10 Orphan Devices Guidance acknowledges that gaps in pre-market clinical data may be addressed through targeted PMCF activities. These may include PMCF investigations, clinical registries, and other clinically relevant post-market information, including real-world data. In such scenarios, a well-designed survey may play a meaningful role in closing evidence gaps from real-world data while maintaining regulatory compliance.

Conclusion

Healthcare Professional surveys are not a substitute for clinical investigations, but they can be a valuable component of a well-designed PMCF strategy. When properly structured, surveys provide real-world insights that help confirm device safety, performance, and patterns of clinical use.

Their regulatory acceptability ultimately depends on whether they address clearly defined clinical questions, generate structured and analyzable data, and complement other post-market evidence sources.

As Notified Bodies continue to apply risk-based scrutiny to clinical evidence under MDR, manufacturers must ensure that survey-based PMCF approaches are scientifically robust and integrated within a broader post-market surveillance framework.

Celegence can support medical device manufacturers for PMCF strategy and execution with a structured, compliant, and efficient approach. Reach out to info@celegence.com learn more.