Planning, designing and implementing high-quality (Level 4) post-market clinical follow-up surveys

English

Since the implementation of the European Medical Device Regulation (MDR), device manufacturers are required to be more proactive in assessing the safety and performance of their products, backing this up with clinical data and post-market monitoring. The data collected are then used to update risk management and the clinical evaluation of each device. Post-market clinical follow-up (PMCF) surveys have become a hot topic across the industry, as they offer a cost-effective solution for PMCF data collection, albeit implementing them effectively can be troublesome. This article by Marcus Torr, Martha Vakalopoulou, Tonika Chester, Christopher Webb and Tom Melvin focuses on high-quality, case/patient specific PMCF surveys, providing Level 4 data, and outlining how to plan, design and implement these for successful submission to the Notified Bodies and for MDR certification.

Specification: 14 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the November 2023 issue of the Journal of Medical Device Regulation and is made available free of charge by the authors.