Making claims about a device appears deceptively simple as a statement about what a device does. But in regulatory practice - especially under the EU MDR and UK MDR - claims are far more than that. They define the device’s intended purpose, which not only describes what the device is designed to do but also dictates the regulatory scope of the device itself.

Clinical Evaluation is more than documentation. It is an ongoing process of analysing evidence, assessing safety and performance, and demonstrating that a medical device delivers clinical benefit throughout its lifecycle.

In December 2025, the European Commission proposed targeted amendments to the EU medical device framework aimed at simplifying MDR and IVDR requirements. Among the most significant changes are broader acceptance of clinical and non-clinical data, more flexible equivalence provisions, and the introduction of “well-established technologies” for legacy devices - developments that could reshape clinical evidence strategies in 2026 and beyond.

This article outlines how clinical evaluation under the EU MDR can, in certain cases, be conducted without new clinical trials, and explains the regulatory pathways, evidence requirements, and role of PMCF in demonstrating safety and performance.

This article outlines the types of clinical data sources that are accepted, identifies common sources of non-compliance, and provides practical guidance for building a robust, compliant clinical evidence strategy under the MDR framework.