欧盟为了统一联盟内各国医疗器材的管理规定,而制订医疗器材指令,简称MDD。这些指令已于95年起陆续生效,凡符合该指令的产品必须贴CE标志,制造者通过CE标志声明其生产的产品符合欧盟对该类产品安全及卫生 In order to unify management regulations of medical equipment in various countries within the Union, the EU has formulated the Medical Equipment Directive, or MDD for short. These directives have been put into effect since 1995, where the products comply with the directive CE mark must be affixed, manufacturers declare by CE mark that their products comply with the EU’s safety and health of such products