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Solutions Circle: Effective Strategies for High-Quality Clinical Data Collection Through Post-Market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
Description: Since the introduction of the EU MDR 2017/745, Post Market Clinical Follow-up (PMCF) has emerged as essential for detecting safety concerns or performance issues that may arise from real-world (RW) medical device (MD) use, providing a more comprehensive understanding of MDs long-term effects. In comparison to premarket clinical trials, PMCF allows the identification of rare or long-term adverse events by collecting data from larger and more diverse patient populations over extended periods of time.
As such, PMCF surveys and MD registries gained prominence for RW data collection, becoming crucial for assessing MD performance. By combining the insights from these two data collection tools, healthcare stakeholders can form a more complete understanding of the RW impact of MDs, leading to improve patient care, enhance device quality, and better regulatory compliance.
PMCF surveys come in two types: general usability surveys (Level 8 data) and patient/case-level surveys (Level 4 data), with Notified Bodies and manufacturers favoring high-quality level 4 PMCF surveys for their specificity and reliability. But implementation of such surveys requires careful consideration of various factors, and a solution-oriented approach to overcome associated challenges.
Alas, current medical device registries lack uniformity and standardization in structure, methodologies, and data collection practices, making it difficult to compare and generalize findings across countries. This lack of transparency hinders the ability of regulators and other stakeholders to assess the reliability and validity of the data collected.
This solution circle intends to provide a platform for attendees to share their experiences when collecting data from surveys and registries. Guidance will be offered on important factors to consider during design and implementation of level 4 PMCF surveys; and in developing comprehensive trustworthy MD registries with clearly define outlier detection methods and objective performance classification systems, in order to enable a lifetime evaluation of MDs.
Learning Objectives:
Discuss PMCF collection data options and understand which are most appropriate to meet specific objectives depending on device type
Understand how PMCF surveys can help to collect Level 4 data, including both the key considerations for implementation and pitfalls to avoid
Discuss the implementation of objective performance classification in MD registries, and recognize the principles needed to evaluate whether the quality of clinical data meets the scientific standards needed for PMCF
