歐盟對(duì)防護(hù)服的準(zhǔn)入要求有哪些？

What are the access requirements of EU for protective clothing?

答：防護(hù)服分為醫(yī)用防護(hù)服和個(gè)人防護(hù)服，管理要求與口罩基本類似。醫(yī)用防護(hù)服按照醫(yī)療器械管理，其中無菌醫(yī)用防護(hù)服需按照歐盟醫(yī)療器械指令93/42/EEC（MDD）或歐盟醫(yī)療器械條例EU2017/745（MDR）獲得CE認(rèn)證，非無菌醫(yī)用防護(hù)服只需進(jìn)行CE自我聲明。個(gè)人防護(hù)服需按照歐盟個(gè)人防護(hù)設(shè)備條例EU2016/425（PPE）獲得CE認(rèn)證。

歐盟口罩、防護(hù)服等防疫物資CE認(rèn)證公告機(jī)構(gòu)在哪里查詢？

答：歐盟醫(yī)療器械指令93/42/EEC（MDD）授權(quán)的公告機(jī)構(gòu)查詢地址：

歐盟醫(yī)療器械條例EU 2017/745（MDR）授權(quán)的公告機(jī)構(gòu)查詢地址：

歐盟個(gè)人防護(hù)裝備條例EU2016/425（PPE）授權(quán)的公告機(jī)構(gòu)查詢地址：

A: the protective clothing is divided into medical protective clothing and personal protective clothing. The management requirements are basically similar to those of masks. Medical protective clothing is managed according to medical devices. Sterile medical protective clothing shall obtain CE certification according to EU medical device directive 93 / 42 / EEC (MDD) or EU medical device regulation eu2017 / 745 (MDR). Non sterile medical protective clothing only needs CE self declaration. Personal protective clothing shall be CE certified in accordance with the EU personal protective equipment regulation eu2016 / 425 (PPE).

Where is the CE certification body for EU respirators, protective clothing and other epidemic prevention materials?

Answer: inquiry address of notified body authorized by EU medical device directive 93 / 42 / EEC (MDD):

Inquiry address of notified body authorized by EU medical device regulation EU 2017 / 745 (MDR):

Inquiry address of the notified body authorized by EU personal protective equipment regulation eu2016 / 425 (PPE):

李國(guó)杰（經(jīng)理）：18202125732  

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