The International Medical Device Regulators Forum (IMDRF) have released a guidance document intended to aid with the design, implementation and appropriate use of post-market clinical follow-up (PMCF) studies.
PMCF studies have been identified as one of many viable tools to use in a post-market surveillance program, they also contribute to the risk management process. They are useful to identify and understand uncertainties about a device post-approval such as rare adverse events, potential benefits, long-term safety and the clinical effectiveness. The guidance provides a list of circumstances in which these uncertainties are more likely to exist and therefore would indicate the need for a PMCF study:
- Unanswered questions of long-term safety, clinical performance and/or effectiveness
- Novel technologies or new intended use
- Higher-risk device and use scenarios
- Uncertainties in generalising clinical investigation results
- Devices approved with clinical data from comparable devices
- Emergence of new information relating to safety, clinical performance and/or effectiveness
- Urgent market access in public health emergencies
- Rare anticipated adverse events
- Effectiveness of the mitigation for a known risk.
The IMDRF also provide insight into the necessary elements of a PMCF study. It is required that the objectives of a study are clearly stated. In addition, a scientifically sound study design with appropriate rationale and statistical analysis must be outlined in the study plan. The implementation of the study will be done according to this study plan, with the results being interpreted and appropriate conclusions drawn.
This last point forms the basis of the final section of the core guidance where the IMDRF highlights how information from PMCF studies should be used. The data and conclusions drawn from a PMCF study form part of the post-market surveillance program and are used in the clinical evaluation and risk management processes. PMCF studies may lead to a reassessment of a device that results in corrective or preventive actions being conducted. Additionally, clinical data generated from PMCF studies can then be used as premarket clinical evidence or supplementary data for future marketing authorisation applications, be used to develop objective performance criteria/goals and form control/comparison groups.
The document also contains three appendices:
- Appendix A – Examples of clinical experience data sources for PMCF studies
- Appendix B – Considerations for using clinical experience data for PMCF studies
- Appendix C – Potential biases and confounding in PMCF studies and controlling methods.
To view the guidance in full, click here.