prEN ISO 18969

Clinical evaluation of medical devices (ISO/DIS 18969:2025) prEN ISO 18969

Publication date:   Dec 18, 2025

Scope

This document specifies principles and a process for the clinical evaluation of medical devices. The process describes planning and performing clinical evaluations. It covers the collection, appraisal and analysis of evidence derived from clinical and where relevant, non-clinical data, to assess and verify the safety and performance or effectiveness including clinical benefit(s) of the device under evaluation (DUE).
This document also:



establishes the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation on behalf of the manufacturer;
 provides manufacturers with a framework within which to conduct the clinical evaluation of medical devices;
provides guidance on the scientific conduct of a clinical evaluation, thereby supporting the credibility of conclusions.



Not all requirements of this document apply to each device type or medical device life cycle phase.
While other parties can contribute to the clinical evaluation process, the responsibility and accountability remain with the manufacturer.
This document does not apply to in vitro diagnostic medical devices.

Related legislation

Legislation related to this standard