High quality PMCF surveys under the EU MDR – from planning through to execution and data analysis

English

Post Market Clinical Follow up (PMCF) is a continuous process conducted by manufacturers to proactively collect and evaluate clinical data for the medical devices that they have placed on the market. With the implementation of Regulation (EU) 2017/745 on medical devices (MDR), PMCF became mandatory for all devices placed on the market in the European Union (EU). This article by Christopher Webb, Marcus Torr, Jorn van Binsbergen, Amber Majoor, Martha Vakalopoulou Paschalidou and Lily Pitter outlines all applicable stages in the process of creating and executing high quality PMCF surveys, often illustrated with practical examples. The elements required within a PMCF survey have been extensively discussed with specific emphasis on how to link clinical claims to measurable outcome parameters and acceptance criteria. Questionnaire design has been identified as the critical factor in ensuring accurate and measurable data are collected. Moreover, a proper methodology for execution of a PMCF survey has been set out, including survey programming and validation, data collection and data management. Finally, some examples of final data analysis have been described, alongside guidance on what to do should the data collected not be as anticipated and unable to meet the acceptance criteria.

Specification: 18 pages plus covers, in English, supplied by email as a PDF.

This article has been published in the February 2025 issue of the Journal of Medical Device Regulation.