Abstract

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.

Begin

2023-02-22

WI

00206096

Planned document number

DIN EN ISO 18969

Project number

02703396

Responsible national committee

NA 027-07-20-01 AK - Clinical Evaluation  

Responsible european committee

CEN/TC 206 - Biological and clinical evaluation of medical devices  

Responsible international committee

ISO/TC 194/WG 4 - Clinical investigation and evaluation of medical devices in humans  

draft standard

Clinical evaluation of medical devices (ISO/DIS 18969:2025); German and English version prEN ISO 18969:2025
2026-01
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