From data to confidence: PMCF survey success for a Class III Guidewire
The challenge
As part of compliance with the EU Medical Device Regulation (MDR), the manufacturer of a Class III guidewire needed to generate robust Post Market Clinical Follow-Up (PMCF) data to confirm ongoing safety and performance. The study was designed to evaluate two key endpoints:
• Procedural success, which served as the primary performance measure
• Freedom from adverse events, which addressed safety
The acceptance criteria was defined according to the current State of the Art (SOTA), with a target of at least 90% procedural success and an overall adverse event rate of no more than 4%.
A major challenge involved addressing clinical evidence gaps across both device variants and patient populations. Data was required for all available guidewire sizes, from the smallest to the largest French sizes, as well as across the full spectrum of patients, ranging from neonates to adults. Ensuring adequate representation of each subgroup was essential for demonstrating consistent device performance and safety across all intended uses.
The solution
To address these requirements, a structured PMCF survey approach was implemented to collect Level 4 clinical data. Healthcare professionals who had used the device within the previous 30 days were invited to participate. Each completed survey corresponded to one patient case in which the guidewire had been used. Respondents were asked to provide data based on patient records or charts, ensuring the information reflected real-world clinical use.
Participants were permitted to complete multiple surveys, each representing a different patient, allowing for broader data capture and more comprehensive analysis. The study combined both retrospective and prospective data collection methods, providing flexibility and ensuring that sufficient data were gathered across all device variants and patient demographics.
The outcomes
This targeted PMCF approach successfully addressed the identified clinical gaps by capturing age specific and variant specific data. Responses were collected across six distinct patient age groups, ensuring that performance and safety outcomes could be validated from neonatal through adult populations. In addition, feedback was obtained for the entire range of device variants, including multiple French sizes, thereby demonstrating consistent usability and reliability across the product line.
Survey questions were designed to directly evaluate the predefined performance and safety endpoints:
Performance: clinicians were asked whether the device was able to be used as intended during each procedure
Safety: clinicians were asked whether any adverse events or complications occurred, if so, whether they were related to the guidewire.
The resulting PMCF data provided strong evidence supporting the device’s continued safety and effectiveness. The study achieved a 95% procedural success rate, surpassing the target of ≥90%, and demonstrated an overall adverse event rate of 2.5%, well below the acceptance threshold of ≤4%.
Conclusion
Through conducting a sound and well executed PMCF survey, the manufacturer was able to collect Level 4 clinical data that met EU-MDR post market evidence requirements. The findings confirmed validated performance and safety across all patient age groups and device variants, thereby strengthening the manufacturer’s regulatory position. By leveraging real-world data collection through clinician surveys, our client not only fulfilled its EU-MDR obligations but also reinforced confidence in the guidewire’s clinical performance and safety profile.