欧盟医疗器械标准简介

Standards Used in the Regulation of Medical Device in EU

欧盟医疗器械标准管理体系由指令、协调标准以及符合性评估程序组成。欧盟指令规定的是产品的"基本要求";协调标准则是规定符合指令基本要求的技术规范,如果产品满足相关协调标准,即可推断该产品符合相应指令规定的基本要求;符合性评估程序是指直接或间接用来确定产品是否达到技术法规或标准相关要求的任何程序。产品评定合格后加贴CE标志,可在欧盟市场内自由流通。本文从医疗器械指令、医疗器械协调标准以及符合性评估程序三部分来介绍欧盟医疗器械标准体系。

Medical devices standards system in EU is composed of directive,harmonized standards and confortuity assessment procedures. The directive nules essential requirements to products and describes the methods, by which conformity with these requirements can be demonstrated. The harmonized standard is a technical specification with the purpose of supporting the essential requirements of the directive. The conformity assessment procedures are used to demonstrate if the devices meet the essential requirements. Production with CE mark can be sold freely in EU market. This article introduced the medical devices standards system in EU from the directive, harmonized standards and conformity assessment procedures.