医用外科口罩CE认证使用范围说明

迈入2020年，新型冠状病毒疫情从袭击中国到全球墓延。由于这场病毒的特殊性以及恐怖的传摇能力，截至目前除中国以外全球受新冠肺炎疫情影响的国家和地区数

已经过百，确诊人数也已经超过十万。意大利，韩国，伊朗，日本，德国，法国，西班牙，美国等国家已经启动了卫生应急响应，口罩在许多国家已经供不应求。国

内医疗器械制造商在满足国内[罩需求的同时也开始抓紧筹备欧盟市场和美国市场。

近期，Crtification Experts B,V.中国分公司收到很多国内医疗器械制造商关于医用外科口罩欧盟CE认证的咨询，我们将大多数问题汇集整理。现在我们来了解下医

用外科口罩的CE认证以及欧盟要求。

医用外科口罩的要求:

根据新医疗器械法规(MDR) Chapter I中Article2对于医疗器械的定义，医用外科[罩属于医疗器械，应符合新医疗器械法规(MDR)的相关要求。

2017年5月5日，欧盟官方期刊(official Journal of the European Union)正式发布了欧盟医疗器械法规(REGULATION (EU) 2017/745,简称"MDR" ) MDR

将取代Directives 90/385/EEC (有源植 入类医疗器械指令) and 93/42/EEC (医疗器械指令)依据MDR Article 123的要求，MDR于2017年5月26日正式生效， 并

52020年5月26日期正式取代MDD (93/42/EEC) 和AIMDD (90/385/EEC)

医用外科口罩的分类:

根据医疗器械法规(MDR)的Chapter V中Article 41对于医疗器械的分类，非无菌医用外科口罩属于类医疗器械，无菌医用外科口罩属于Is类医疗器械。

医用外科口罩的符合性评定:

Manufacturers of devices classified as class，other than custommade or investigational devices, shall declare the conformity of their products by issuing

the EU declaration of conformity referred to in Article 17 after drawing up the technical documentation set out in Annex II. If the devices are placed on

the market in sterile condition, are reusable surgical instruments or have a measuring function, the manufacturer shall apply the procedures set out in

Annex VII, Chapter | (Quality Management System) and Chapter I Administrative provisions), or in Part A of Annex X. However, the involvement of the

notified body shall be limited:

a.in the case of devices placed on the market in sterile condition, to the aspects concerned with establishing, securing and maintaining sterile

conditions,

b. in the case of devices with a measuring function, to the aspects concerned with the conformity of the devices with the metrological requirements;

c. in the case of reusable surgical instruments, to the aspects related to the reuse of the device, in particular cleaning, disinfection, sterilization,

maintenance and functional testing and the related instructions for use.

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