NEWS

The EN ISO 18113 series outlines key requirements that manufacturers must provide for information accompanying in vitro diagnostic (IVD) medical devices, including the product label and instructions for use. It encompasses various aspects of IVD medical devices, with specific parts in the standard series dedicated to reagents and instruments intended to meet the specific needs of both professional and self-testing users.

The motivation for this Workshop came from multiple European research projects and large-scale pilots that found that they were all needing to identify the most suitable lawful basis for collecting and processing personal health data for the development, deployment, testing and evaluation of digital health innovations. This CWA aims to combine the experience of various R&I projects regarding this topic in a best practice guide on how to obtain user consent for personal health information.