深圳深圳醫用外科口罩CE認證第三方檢測報告

全球受新冠肺炎疫情影響的國家和地區數量已經過百，確診人數也已經超過十萬。意大利，韓國，伊朗，日本，德國，法國，西班牙，美國等國家已經啟動了衛生應急響應，口罩在許多國家已經供不應求。國內醫療器械制造商在滿足國內口罩需求的同時也開始抓緊籌備歐盟市場和美國市場。

近期，Certification Experts B,V. 中國分公司收到很多國內醫療器械制造商關于醫用外科口罩歐盟CE認證的咨詢，我們將大多數問題匯集整理?，F在我們來了解下醫用外科口罩的CE認證以及歐盟要求。

醫用外科口罩的要求：

根據新醫療器械法規（MDR）Chapter I 中Article2對于醫療器械的定義，醫用外科口罩屬于醫療器械，應符合新醫療器械法規（MDR）的相關要求。

2017年5月5日，歐盟官方期刊（Official Journal of the European Union）正式發布了歐盟醫療器械法規（REGULATION (EU) 2017/745，簡稱“MDR”）。MDR將取代Directives 90/385/EEC （有源植入類醫療器械指令）and 93/42/EEC（醫療器械指令）。依據MDR Article 123的要求，MDR于2017年5月26日正式生效，并與2020年5月26日期正式取代MDD（93/42/EEC）和AIMDD（90/385/EEC）。

醫用外科口罩的分類：

根據醫療器械法規（MDR）的Chapter V中Article 41對于醫療器械的分類，非無菌醫用外科口罩屬于I類醫療器械，無菌醫用外科口罩屬于Is類醫療器械。

醫用外科口罩的符合性評定：

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.

醫用外科口罩的技術文件：

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

從上述要求來看，對于無菌醫用外科口罩，如果目前還沒有獲得公告機構（Notified Body）的審核，臨時去申請CE認證已經沒有任何可能性。因此目前出口到歐洲的醫用外科口罩產品應該只有非無菌醫用外科口罩這一個選項。但是非無菌醫用外科口罩并不是對生產環境和生產工藝完全不控制，EN 14683對于醫用外科口罩的初始污染菌要求是不大于30cfu/g。