naSRPS EN ISO 18969:2023

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

Scope

This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended.
The requirements of this document are applicable throughout the life cycle of a medical device. The process described in this document applies to the assessment of risks and benefits from clinical data obtained from the use of medical devices in humans.

This document specifies general requirements intended to
— verify the safety of medical devices when used in accordance with their instructions for use;
— verify that the clinical performance or effectiveness of a medical device meet the claims of the manufacturer in relation to its intended use;
— verify that there is sufficient clinical evidence to demonstrate the achievement of a positive benefit/risk balance when a medical device is used in the intended patient population in accordance with its intended use;
— ensure the scientific conduct of a clinical evaluation and the credibility of conclusions drawn on the safety and performance of a medical device;
— define the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation; and
— assist manufacturers, clinicians, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Note 1 This standard can be used for regulatory purposes.
Note 2 This document does not apply to in vitro diagnostic medical devices. However, there may be situations, dependent on the device and national or regional requirements, where sections and/or requirements of this document might be applicable.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.