PMCF expertise published in Journal of Medical Device Regulation

How can high-quality PMCF surveys be conducted under the EU MDR? We are excited to share a free article published in the JMDR February 2025 issue, “𝐇𝐢𝐠𝐡-𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐏𝐌𝐂𝐅 𝐬𝐮𝐫𝐯𝐞𝐲𝐬 𝐮𝐧𝐝𝐞𝐫 𝐭𝐡𝐞 𝐄𝐔 𝐌𝐃𝐑 – 𝐟𝐫𝐨𝐦 𝐩𝐥𝐚𝐧𝐧𝐢𝐧𝐠 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐭𝐨 𝐞𝐱𝐞𝐜𝐮𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐝𝐚𝐭𝐚 𝐚𝐧𝐚𝐥𝐲𝐬𝐢𝐬.” The article is written in collaboration with Jorn van Binsbergen, Amber Majoor, Marcus Torr, Chris Webb, Martha Vakalopoulou-Paschalidou, and Lily Pitter.

Jorn van Binsbergen, one of our writers, sums it up best:

“A well-structured PMCF survey is not just a compliance exercise—it’s the key to generating meaningful clinical evidence that truly supports patient safety and product performance.”

Download the article to gain integral PMCF insights, including:

• Understand all applicable stages in the process of creating and executing high-quality PMCF surveys, often illustrated with practical examples;
• Identify the elements required within a PMCF survey, with specific emphasis on how to link clinical claims to measurable outcome parameters and acceptance criteria;
• Understand that the questionnaire design is the critical factor in ensuring accurate and measurable data are collected;
• Learn how a proper methodology for the execution of a PMCF survey is set out, including survey programming and validation, data collection, and data management;
• Study some examples of final data analysis, along with guidance on what to do should the data collected not be as anticipated and unable to meet the acceptance criteria.

Download the article via the link: https://lnkd.in/eZimnhnS.