全球受新冠肺炎疫情影响的国家和地区数量已经过百，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口罩需求的同时也开始抓紧筹备欧盟市场和美国市场。
近期，Certification 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，医用外科口罩属于医疗器械，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，并与2020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I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 I, 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 VIII, Chapter I (Quality Management System) and Chapter III (Administrative provisions), or in Part A of Annex X. However, the involvement of the notified body shall be limited:
in the case of devices placed on the market in sterile condition, to the aspects concerned with establishing, securing and maintaining sterile conditions,
in the case of devices with a measuring function, to the aspects concerned with the conformity of the devices with the metrological requirements;
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.
医用外科口罩的技术文件：
The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organized, readily searchable and unequivocal way and shall include in particular the following elements: described in this annex II.
Device description and specification, including variants and accessories
Information supplied by the manufacturer
Design and manufacturing information
General safety and performance requirements
Risk/benefit analysis and risk management
Product verification and validation
Technical documentation on post-market surveillance
EU declaration of conformity
从上述要求来看，对于无菌医用外科口罩，如果目前还没有获得公告机构（Notified Body）的审核，临时去申请CE认证已经没有任何可能性。因此目前出口到欧洲的医用外科口罩产品应该只有非无菌医用外科口罩这一个选项。但是非无菌医用外科口罩并不是对生产环境和生产工艺完全不控制，EN 14683对于医用外科口罩的初始污染菌要求是不大于30cfu/g。