体外诊断医疗器材申请CE认证指南

Guidance for In-vitro Diagnostic Medical Device application for CE mark

欧盟的体外诊断医疗器材指令98/79/EC已在2003年12月开始强制执行,所有体外诊断医疗器材,包括性能评价的器材,在它们投放市场前必须打上CE符合性的标记。欧盟所有的成员国在该指令生效后符合此指令的体外诊断医疗器材,在本国的版图内必须接纳它。本文提供了一个指南,针对体外诊断医疗器材申请CE认证,它教给制造商如何一步一步地获得CE认证。

Directive 98/79/EC for In-vitro Diagnostic Medical Device (IVDD) came to be mandatory on Dec 2003 in European Communities. All In-vitro Medical Devices, other than devices for performance evaluation must bear the CE marking of conformity when they are placed on the market. Member States shall accept the placing on the market of devices which conform to the rules in force in their territory on the date on which this Directive enters into force. This document provides guidance on In-vitro Diagnostic Medical Device application for CE mark. It provides a step-by-step procedure to help manufacture how to do.