Understanding medical device classes in patient monitoring

Developing a patient monitoring device brings unique regulatory challenges, where classification decisions can significantly affect evidence requirements, timelines, and risk. This practical guide, written by our MedTech regulatory expert, helps innovators understand how patient monitoring technologies are classified and what that means in practice for development and approval.

It explains how intended use, clinical context, and system design influence regulatory expectations across UKCA, CE, and FDA pathways, and highlights where teams commonly encounter avoidable delays. Written for startups, SMEs, and large organisations looking for a refresher, the guide provides clear insight into how regulatory strategy should shape technical and clinical decisions. Download it to build a more informed approach and progress your patient monitoring device towards market with confidence.