近期，歐美口罩的認(rèn)證和標(biāo)準(zhǔn)成為廣大外貿(mào)出口和貨代物流企業(yè)關(guān)注的焦點(diǎn)！據(jù)搜航網(wǎng)最新獲悉，上周，美國(guó)疾病控制與預(yù)防中心(CDC)正式發(fā)布涉及口罩標(biāo)準(zhǔn)規(guī)定的《優(yōu)化N95口罩供應(yīng)策略：危機(jī)/替代策略》！
CDC宣布接受N95口罩中國(guó)標(biāo)準(zhǔn)
這是一個(gè)事關(guān)所有計(jì)劃出口美國(guó)的外貿(mào)物流企業(yè)的事件，公告指出：新冠肺炎疫情期間，當(dāng)N95口罩供給不足時(shí)，按下表中標(biāo)準(zhǔn)生產(chǎn)的口罩，是N95口罩合適的替代品。其中包括采用中國(guó)標(biāo)準(zhǔn)GB 2626-2006 和GB/T 18664—2002生產(chǎn)的口罩。
Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies
Crisis/Alternate Strategies
These crisis capacity or alternate strategies accompany and build on the conventional and contingency capacity strategies. The following measures are not commensurate with current U.S. standards of care.
However, individual measures or a combination of these measures may need to be considered during periods of expected or known N95 respirator shortages. It is important to consult with entities that include some combination of: local healthcare coalitions, federal, state, or local public health officials, appropriate state agencies that are managing the overall emergency response related to COVID-19, and state crisis standards of care committees.
Even when state/local healthcare coalitions or public health authorities can shift resources between health care facilities, these strategies may still be necessary.
目前在疫情期間，進(jìn)入美國(guó)市場(chǎng)都需要進(jìn)口商向FDA申請(qǐng)獲取口罩的緊急使用資質(zhì)，符合以下標(biāo)準(zhǔn)的N95口罩，可以簡(jiǎn)化原美國(guó)FDA注冊(cè)流程以及NIOSH的檢測(cè)流程，快速投入使用。
國(guó)家 | 執(zhí)行標(biāo)準(zhǔn) | 可接受的產(chǎn)品等級(jí) | 標(biāo)準(zhǔn)/指導(dǎo)文件 | 防護(hù)系數(shù)≥ 10 |
澳大利亞 | AS/NZS 1716:2012 | P3 P2 | AS/NZS 1715:2009 | YES |
巴西 | ABNT/NBR 13698:2011 | PFF3 PFF2 | Fundacentro CDU 614.894 | YES |
中國(guó) | GB 2626-2006 | KN100 KP100 KN95 KP95 | GB/T 18664—2002 | YES |
歐盟 | EN 149-2001 | FFP3 FFP2 | EN 529:2005 | YES |
日本 | JMHLW-2000 | DS/DL3 DS/DL2 | JIS T8150: 2006 | YES |
韓國(guó) | KMOEL-2017-64 | Special 1st | KOSHA GUIDE H-82-2015 | YES |
墨西哥 | NOM-116-2009 | N100, P100, R100，N99, P99, R99， N95, P95, R95 | NOM-116 | YES |
美國(guó)NIOSH要求 | NIOSH approved
42 CFR 84 | N100, P100, R100，N99, P99, R99， N95, P95, R95 | OSHA 29CFR1910.134 | YES |
▲表格來(lái)源深圳海關(guān)官網(wǎng)
早前，美國(guó)副總統(tǒng)彭斯在3月5日新聞發(fā)布會(huì)上告訴大家，“除非病了，否則無(wú)需購(gòu)買(mǎi)口罩”。
這真是啪啪的打臉，但也給國(guó)內(nèi)口罩生產(chǎn)商和貿(mào)易企業(yè)創(chuàng)造了出口機(jī)會(huì)，而且美國(guó)也已取消口罩等部分防疫產(chǎn)品的關(guān)稅加征。
不僅美國(guó)，同樣深陷新冠肺炎疫情的歐洲，同樣特事特辦，緊急開(kāi)通了口罩類防疫物資的綠色通道。
近日，歐美緊急放寬口罩等防疫物資準(zhǔn)入要求（CE認(rèn)證和FDA認(rèn)證），需要機(jī)構(gòu)認(rèn)證的產(chǎn)品在完成合規(guī)性評(píng)估程序之前（即取得CE/FDA標(biāo)志之前）可以先出口，但是要確保認(rèn)證工作會(huì)繼續(xù)完成。
歐盟成員國(guó)主管當(dāng)局可在疫情期間評(píng)估和集中采購(gòu)沒(méi)有CE標(biāo)記的防疫產(chǎn)品，該產(chǎn)品僅可以提供給醫(yī)護(hù)人員使用，不能在市場(chǎng)上流通銷售。如果你的產(chǎn)品不是政府集中采購(gòu)，且要在當(dāng)?shù)厥袌?chǎng)上銷售的，則不屬于上述放寬準(zhǔn)入的條件范圍。
2020年3月13日，歐盟會(huì)員會(huì)在歐洲官方雜志( Official Journal of the EuropeanUnion）發(fā)布了疫情期間針對(duì)醫(yī)療器械和個(gè)人防護(hù)用品 (PPE)的符合性評(píng)價(jià)和市場(chǎng)監(jiān)督程序的建議。
醫(yī)療器械方面：
◆如果市場(chǎng)監(jiān)督機(jī)構(gòu)確定產(chǎn)品符合醫(yī)療器械的基本安全和性能要求，即使其符合性評(píng)價(jià)還未完成，市場(chǎng)監(jiān)督機(jī)構(gòu)可以允許其在一定的時(shí)間內(nèi)進(jìn)行銷售，同時(shí)該產(chǎn)品必須繼續(xù)完成其符合性評(píng)價(jià)過(guò)程。
◆成員國(guó)主管當(dāng)局也可在疫情期間評(píng)估和組織采購(gòu)沒(méi)有CE標(biāo)記的醫(yī)療器械，該產(chǎn)品僅可提供給醫(yī)療工作者使用，不能在市場(chǎng)上流通銷售。同時(shí)市場(chǎng)抽查將會(huì)重點(diǎn)抽查防疫相關(guān)醫(yī)療器械，以防止不合格產(chǎn)品導(dǎo)致嚴(yán)重風(fēng)險(xiǎn)。
個(gè)人防護(hù)用品（PPE）方面：
◆涉及的產(chǎn)品包括拋棄式和可重復(fù)使用的口罩、可重復(fù)使用的工作服、手套和眼罩等（主要是預(yù)防病毒和有害物質(zhì)的產(chǎn)品）。需要具有PPE法規(guī)授權(quán)資格的公告機(jī)構(gòu)進(jìn)行符合性評(píng)價(jià)。
◆應(yīng)急審批產(chǎn)品如果不采用PPE法規(guī)協(xié)調(diào)標(biāo)準(zhǔn)作為產(chǎn)品技術(shù)要求而采用其它技術(shù)要求，比如WHO的推薦要求，須確保采用的技術(shù)要求與PPE法規(guī)基本健康與安全要求同等防護(hù)水平。公告機(jī)構(gòu)對(duì)這類采用其它技術(shù)要求的PPE產(chǎn)品進(jìn)行發(fā)證時(shí)，需要立即通知主管當(dāng)局和其它PPE法規(guī)的公告機(jī)構(gòu)。
◆如果市場(chǎng)監(jiān)督機(jī)構(gòu)確定產(chǎn)品符合PPE法規(guī)的基本健康和安全要求，即使其符合性評(píng)價(jià)還未完成，市場(chǎng)監(jiān)督機(jī)構(gòu)可以允許其在一定的時(shí)間內(nèi)進(jìn)行銷售，同時(shí)該產(chǎn)品必須繼續(xù)完成其符合性評(píng)價(jià)過(guò)程。
◆成員國(guó)主管當(dāng)局也可在疫情期間評(píng)估和組織采購(gòu)沒(méi)有CE標(biāo)記的PPE產(chǎn)品，該產(chǎn)品僅可提供給醫(yī)療工作者使用，不能在市場(chǎng)上流通銷售。同時(shí)市場(chǎng)抽查將會(huì)重點(diǎn)抽查防疫相關(guān)PPE產(chǎn)品，以防止不合格產(chǎn)品導(dǎo)致嚴(yán)重風(fēng)險(xiǎn)。
也就是說(shuō)，只要處于正在進(jìn)行符合性評(píng)估的過(guò)程中，就可以在沒(méi)有CE標(biāo)志的情況下先行進(jìn)入歐盟市場(chǎng)。由市場(chǎng)監(jiān)督部門(mén)進(jìn)行抽查，發(fā)現(xiàn)問(wèn)題再進(jìn)行處罰。
重點(diǎn)如下?。?！
◆成員國(guó)可采購(gòu)安全有效，但沒(méi)有CE標(biāo)記的醫(yī)療產(chǎn)品；
◆緊急物資專供醫(yī)療人員使用，不可在市場(chǎng)上流通；
◆僅疫情期間有效。
關(guān)于CE標(biāo)識(shí)
CE標(biāo)簽就像一把巨傘，底下是規(guī)定各類產(chǎn)品安全標(biāo)準(zhǔn)、細(xì)分到不同材料和生產(chǎn)模式等的各種歐盟指令。自1985年成立以來(lái)，它就成為了高質(zhì)量、高標(biāo)準(zhǔn)和嚴(yán)格執(zhí)法的標(biāo)志，缺少這一標(biāo)志的商品將不予獲準(zhǔn)進(jìn)入歐盟市場(chǎng)。
如今CE標(biāo)識(shí)已經(jīng)成為了全球認(rèn)可的質(zhì)量標(biāo)志，CE標(biāo)志可以證明該批在歐盟制作或進(jìn)口至歐盟成員國(guó)的產(chǎn)品符合質(zhì)量標(biāo)準(zhǔn)，滿足保護(hù)消費(fèi)者健康、供應(yīng)鏈安全和環(huán)境可持續(xù)發(fā)展的要求。
| 歐盟口罩要求 |
|---|
| 在歐盟，口罩屬于PPE個(gè)人防護(hù)用品，“危及健康的物質(zhì)和混合物”。2019年起，歐盟新法規(guī)PPE Regulation (EU) 2016/425強(qiáng)制執(zhí)行，所有出口歐盟的口罩必須在新法規(guī)的要求下獲得CE認(rèn)證證書(shū)。CE認(rèn)證證書(shū)的有效期是5年左右，一般費(fèi)用是10000-15000元人民幣。
歐盟對(duì)于口罩歐洲統(tǒng)一，CE認(rèn)證的標(biāo)準(zhǔn)包括BSEN140、BSEN14387、BSEN143、BSEN149、BSEN136，其中BSEN149使用多，為可防護(hù)微粒的過(guò)濾式半口罩，根據(jù)測(cè)試的粒子穿透率分為P1(FFP1)，P2(FFP2)，P3(FFP3)三個(gè)等級(jí)，F(xiàn)FP1低過(guò)濾效果≥80%，F(xiàn)FP2低過(guò)濾效果≥94%，F(xiàn)FP3低過(guò)濾效果≥97%。FFP2口罩與上文提到的醫(yī)用防護(hù)口罩、KN95口罩、N95口罩過(guò)濾效率十分接近。醫(yī)療口罩必須遵循BSEN14683標(biāo)準(zhǔn)，可以分為三個(gè)等級(jí):低標(biāo)準(zhǔn)Type、然后是Type和TypeR。上一個(gè)版本是BSEN146832014，已被新版BSEN146832019所取代。EN 14683:2019年版主要的變化之一是壓力差，Type、Type、TypeR壓力差分別由2014年版的29.4、29.4、49.0Pa/cm，上升至40、40、60Pa/cm。
CE認(rèn)證是歐盟實(shí)行的強(qiáng)制性產(chǎn)品安全認(rèn)證制度，目的是為了保障歐盟國(guó)家人民的生命財(cái)產(chǎn)安全。
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新手小白可以問(wèn)自己的發(fā)證機(jī)構(gòu)兩個(gè)問(wèn)題：
01、貴司是否為NB機(jī)構(gòu)? 機(jī)構(gòu)號(hào)是否可以查詢？
02、出具的CE證書(shū)在官網(wǎng)可查嗎？
NB機(jī)構(gòu)可以理解為被歐盟授權(quán)或認(rèn)可的機(jī)構(gòu)。如果CE證書(shū)是NB機(jī)構(gòu)發(fā)證的，在歐盟就具有一定的效應(yīng)，清關(guān)的風(fēng)險(xiǎn)才會(huì)相對(duì)較小。
正常情況下，根據(jù)歐盟法規(guī)，所有出口歐盟的產(chǎn)品都需要獲得CE認(rèn)證，加貼CE標(biāo)識(shí)才能進(jìn)入歐洲市場(chǎng)。CE認(rèn)證的審核和發(fā)證，歐盟公布了一系列由歐盟統(tǒng)一監(jiān)管和認(rèn)證資質(zhì)授權(quán)的機(jī)構(gòu)，并授予每家機(jī)構(gòu)一個(gè)唯一的四位數(shù)編碼即公告號(hào)，CE證書(shū)的申請(qǐng)和頒發(fā)就由對(duì)應(yīng)法規(guī)和指令授權(quán)的公告號(hào)機(jī)構(gòu)頒發(fā)。
在歐盟官方網(wǎng)站-歐盟公告機(jī)構(gòu)查詢官網(wǎng)，廠家可以查詢到目前從0001-2786 兩千多家歐盟公告號(hào)機(jī)構(gòu)詳細(xì)信息，每家機(jī)構(gòu)對(duì)應(yīng)的指令和法規(guī)授權(quán)以及發(fā)證機(jī)構(gòu)信息都可在該網(wǎng)站查詢到。
附：CE認(rèn)證查驗(yàn)：
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main
附：FDA查驗(yàn)(出口美國(guó)需要FDA和NIOSH）：
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
近期，大家都在對(duì)口罩等醫(yī)療物資的歐盟標(biāo)準(zhǔn)犯愁，都是一知半解的狀態(tài)。在此附上原文查看：
COMMISSION RECOMMENDATION (EU) 2020/403
of 13 March 2020
on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
In the context of the current COVID-19 global outbreak as well as the rapid spread of the virus across various regions of the EU, the demand for personal protective equipment (hereinafter ‘PPE’) such as face masks, gloves, protective coveralls or eyewear protection, as well as for medical devices such as surgical masks, exploration gloves and some gowns, has seen an exponential growth. In particular, the supply chain of certain types of PPE such as the disposable face masks is under severe strain, due to the exponential growth of the demand both via existing as well as via new channels. In addition, the global supply chain of such products has also sustained significant disruptions, which have induced repercussions on the EU market as well.
Bearing in mind that the health and safety of the EU citizens is of upmost priority, it is of paramount importance to ensure that the most appropriate PPE and medical devices ensuring adequate protection are swiftly made available to those who need it most.
Economic operators active across the EU are working relentlessly to increase their respective manufacturing and distribution capacity. In order to mitigate the effects of the various disruptive factors, the economic operators are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base. These efforts by the industrial stakeholders would not be able to produce their full effects if the increased supply cannot feed into the market without any undue delays.
The requirements for the design, manufacturing and placing on the market of personal protective equipment are laid down by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (1).
The requirements for the design, manufacturing and placing on the market of medical devices are laid down by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2). That Directive is repealed by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (3), with effect from 26 May 2020.
Disposable and re-usable face masks ensuring protection against particulate hazards, disposable and re-usable coveralls, gloves and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses are products falling within the scope of the Regulation (EU) 2016/425.
Surgical masks, examination gloves and some types of gowns are products falling within the scope of Directive 93/42/EEC and of Regulation (EU) 2017/745.
In the context of the COVID-19 threat, such PPE and medical devices are essential for healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread.
Regulation (EU) 2016/425 fully harmonises the rules for the design, manufacturing and placing on the Union market of PPE and sets out a number of essential health and safety requirements for PPE based on a classification of PPE depending on the risk against which it is intended to protect users. Thus, items of PPE manufactured in accordance with the Regulation (EU) 2016/425 can circulate freely throughout the internal market and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.
Directive 93/42/EEC and Regulation (EU) 2017/745 fully harmonise the rules for the design, manufacturing and placing the Union market of medical devices, and set up a number of essential requirements and of general safety and performance requirements, based on a classification of medical devices depending on specific rules governed by the intended purpose of the devices. Thus, devices manufactured in accordance with the Council Directive 93/42/EEC and Regulation (EU) 2017/745 can circulate freely throughout the internal market and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.
PPE intended to protect against harmful biological agents, such as viruses are listed in Annex I of Regulation (EU) 2016/425 as category III, which includes exclusively the risks that may cause ‘very serious consequences such as death or irreversible damage to health’.
Relevant medical devices as non-invasive devices are in Class I, unless specific rules apply.
In accordance with Article 8 of Regulation (EU) 2016/425, in order to place PPE products on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, affix the CE marking.
In accordance with Article 11 of Directive 93/42/EEC and with Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, in order to place medical devices on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential requirements or general safety and performance requirements has been demonstrated by the appropriate procedure, affix the CE marking. Derogations from conformity assessment procedures may be authorised by Member States, on duly justified request, for the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices the use of which is in the interest of protection of health.
Regulation (EU) 2016/425 is technologically neutral and does not lay down any specific mandatory technical solutions for the design of PPE products. Instead, Annex II to Regulation (EU) 2016/425 sets the essential health and safety requirements, which PPE should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.
Directive 93/42/EEC and Regulation (EU) 2017/745 are technologically neutral and do not lay down any specific mandatory technical solutions for the design of medical devices. Instead, Annex I to Directive 93/42/EEC sets the essential requirements, and Annex I to Regulation (EU) 2017/745 sets the general safety and performance requirements, which medical devices should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.
Article 14 of Regulation (EU) 2016/425 offers the possibility for manufacturers to rely on specific technical solutions, which are detailed in harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union. In accordance with this Article, should a manufacturer choose to adopt such a technical solution, the PPE is presumed to be in conformity with the essential health and safety requirements covered by the said harmonised standard or parts thereof. However, compliance with the harmonised standards is not mandatory. Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the PPE complies with the applicable essential health and safety requirements.
Article 5 of Directive 93/42/EEC and Article 8 of Regulation (EU) 2017/745 offer the possibility for manufacturers to rely on specific technical solutions, which are detailed in harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union. In accordance with this Article, should a manufacturer choose to adopt such a technical solution, the medical device is presumed to be in conformity with the requirements covered by the said harmonised standard or parts thereof. However, compliance with the harmonised standards is not mandatory. Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the medical device complies with the applicable essential health and safety requirements.
Article 19 of Regulation (EU) 2016/425 lays down the specific conformity assessment procedures, which apply to the different categories of PPE. Pursuant to this Article, items of PPE of category III, such as the ones designed protect against harmful biological agents should be subjected to specific combination of conformity assessment procedures, which are described respectively in Annexes V, VII and VIII of the same Regulation. Each of the different conformity assessment procedures, which may be used, require the mandatory involvement of a third party conformity assessment body.
Article 11 of Directive 93/42/EEC and Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, lay down the specific conformity assessment procedures, which apply to the different classes of medical devices. Pursuant to these Articles, medical devices falling within Class I, other than custom-made or investigational devices, should be subjected to the conformity assessment procedure for the EC declaration of conformity, without the involvement of a third party conformity assessment body.
Notified bodies are the conformity assessment bodies designated by Member States and authorised to carry out third party conformity assessment tasks under Regulation (EU) 2016/425. According to Article 26(4) and point 7 (f) of Annex V of Regulation (EU) 2016/425, notified bodies are required to assess that a PPE product meets the applicable essential health and safety requirements. Notified bodies need to carry out this assessment not only where the manufacturer has applied the harmonised standards, but also in a situation where the manufacturer has followed other technical solutions. When delivering the conformity assessment certificates, notified bodies are required to inform their notifying authorities and may also be required to inform other notified bodies of the certificates they have issued, as set out in Article 34 of Regulation (EU) 2016/425.
Notified bodies should thus assess whether products manufactured in line with other technical solutions, such as the ones contained in the WHO recommendations on the appropriate selection of PPE also meet the applicable essential health and safety requirements. In view of the importance to ensure an efficient exchange of information between all stakeholders in the PPE supply chain, where notified bodies conclude that a PPE following another specific standard or technical solution is compliant with the essential health and safety requirements applicable to it, sharing this information will be instrumental in facilitating the assessment of other products manufactured according to the same specific standard or technical solution in a swift manner. To that effect, notified bodies can make use of the existing channels for exchange of information in the framework of the coordination groups established in accordance with Article 36 of Regulation (EU) 2016/425.
In addition, pursuant to the relevant market surveillance procedures in Regulation (EU) 2016/425 and in particular Article 38(1) and (2) thereof, where a market surveillance authority encounters a non-CE marked PPE product they are required to evaluate it. Where, in the course of the evaluation, the market surveillance authorities find that the PPE does not comply with the requirements laid down in the Regulation, they shall require the economic operator to take corrective action to bring the PPE into compliance or to recall or withdraw it, commensurate with the nature of the risk. They shall also inform the Commission and other Member State of the results of the evaluation and the actions which they have required the economic operator to take.
Accordingly, to address the shortage of PPE necessary in the context of the COVID-19 outbreak, where non-CE marked PPE are intended to enter the EU market, the relevant market surveillance authorities should evaluate the products and, if they are found to be compliant with the essential health and safety requirements laid down by the relevant Regulation should take measures allowing the placing of such PPE on the Union market for a limited period of time or while the conformity assessment procedure with the notified body is being carried out. In order to ensure that such products can be made available in other Member States and in view of the importance to ensure an efficient exchange of information as well as a coordinated response to all threats to the citizens’ health and safety, it is appropriate that the market surveillance authority carrying out such an evaluation communicates its decision to other Member States authorities and to the Commission through the regular market surveillance information exchange channels.
Considering that certain types of PPE or medical devices that are used in the context of the COVID-19 outbreak, may also be used for other purposes, it is necessary that Member States take all appropriate measures to ensure that PPE or medical devices not bearing the CE marking, which may be placed on the Union market in accordance with paragraph 8 of the present Recommendation are only made available to healthcare workers,
HAS ADOPTED THIS RECOMMENDATION:
1. With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users’ health and safety.
CONFORMITY ASSESSMENT PROCEDURES
2.The notified bodies under Regulation (EU) 2016/425 should prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
3.In the case of PPE products manufactured following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.
4.Notified bodies which issue certificates to PPE products manufactured following other technical solutions than harmonised standards, should immediately inform the relevant notifying authority as well as the other notified bodies under Regulation (EU) 2016/425 of the certificates issued and the specific technical solution followed. Notified bodies should exchange such information through the coordination of notified bodies group established under Article 36 of Regulation (EU) 2016/425.
5.In the case of medical devices, the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.
MARKET SURVEILLANCE PROCEDURES
6.The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
7.Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
8.PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.
9.Market surveillance authorities should inform immediately the Commission and other Member States of any temporary arrangement they have granted to specific PPE or medical devices. For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS).
Done at Brussels, 13 March 2020.
For the Commission
Thierry BRETON
Member of the Commission
翻譯版供參考，具體請(qǐng)以英文原版為準(zhǔn)：COVID-19威脅范圍內(nèi)的合格評(píng)定和市場(chǎng)監(jiān)督程序
歐洲委員會(huì)，考慮到《歐洲聯(lián)盟運(yùn)作條約》，特別是其第292條，鑒于：
1、在當(dāng)前的COVID-19全球爆發(fā)以及病毒在歐盟各個(gè)地區(qū)的快速傳播的背景下，對(duì)個(gè)人防護(hù)設(shè)備（以下稱“ PPE”）的需求，例如口罩，手套，防護(hù)工作服或眼鏡防護(hù)以及用于外科口罩，探查手套和某些禮服等醫(yī)療設(shè)備的數(shù)量呈指數(shù)增長(zhǎng)。特別是，由于通過(guò)現(xiàn)有渠道以及通過(guò)新渠道的需求呈指數(shù)增長(zhǎng)，某些類型的PPE（例如一次性口罩）的供應(yīng)鏈承受著巨大的壓力。此外，此類產(chǎn)品的全球供應(yīng)鏈也遭受了嚴(yán)重破壞，這也引起了歐盟市場(chǎng)的反響。
2、牢記歐盟公民的健康和安全是重中之重，因此，確保向最需要的人迅速提供最適當(dāng)?shù)膫€(gè)人防護(hù)設(shè)備和醫(yī)療設(shè)備，以確保提供足夠的保護(hù)，這一點(diǎn)至關(guān)重要。
3、活躍于整個(gè)歐盟的經(jīng)濟(jì)運(yùn)營(yíng)商正在不懈努力，以提高各自的制造和分銷能力。為了減輕各種破壞性因素的影響，經(jīng)濟(jì)運(yùn)營(yíng)商正在通過(guò)啟動(dòng)新的生產(chǎn)線和/或使其供應(yīng)商基礎(chǔ)多樣化來(lái)重新設(shè)計(jì)其供應(yīng)鏈。如果供應(yīng)增加而沒(méi)有任何不適當(dāng)?shù)难诱`，則工業(yè)利益相關(guān)者的這些努力將無(wú)法發(fā)揮全部作用。
4、有關(guān)個(gè)人防護(hù)設(shè)備的設(shè)計(jì)，制造和投放市場(chǎng)的要求，由歐洲議會(huì)和理事會(huì)于2016年3月9日頒布的第（EU）2016/425號(hào)條例（關(guān)于個(gè)人防護(hù)設(shè)備）以及廢除理事會(huì)第89/686號(hào)指令規(guī)定/ EEC （1）。
5、1993年6月14日關(guān)于醫(yī)療器械的理事會(huì)指令93/42 / EEC對(duì)醫(yī)療器械的設(shè)計(jì)，制造和投放市場(chǎng)提出了要求 （2）。歐洲議會(huì)和2017年4月5日關(guān)于醫(yī)療器械的理事會(huì)（EU）2017/745條例，該指令2001/83 / EC，條例（EC）178/2002和條例（EC）的修訂已廢除該指令1223/2009和廢除理事會(huì)指令90/385 / EEC和93/42 / EEC （3），自2020年5月26日起生效。
6、一次性和可重復(fù)使用的口罩，可防止顆粒物危害，一次性和可重復(fù)使用的工作服，手套和眼鏡防護(hù)，用于預(yù)防和防止有害生物制劑（如病毒）屬于本法規(guī)范圍內(nèi)的產(chǎn)品（歐盟）2016/425。
7、外科口罩，檢查手套和某些長(zhǎng)袍類型的產(chǎn)品屬于93/42 / EEC指令和2017/745法規(guī)（EU）的范圍。
8、在發(fā)生COVID-19威脅的情況下，此類PPE和醫(yī)療設(shè)備對(duì)于參與遏制病毒并避免其進(jìn)一步傳播的醫(yī)護(hù)人員，急救人員和其他人員至關(guān)重要。
9、（EU）2016/425法規(guī)充分協(xié)調(diào)了PPE的設(shè)計(jì)，制造和投放市場(chǎng)的規(guī)則，并根據(jù)PPE的類別（取決于其所面臨的風(fēng)險(xiǎn)）對(duì)PPE提出了一些基本的健康和安全要求旨在保護(hù)用戶。因此，根據(jù)法規(guī)（EU）2016/425制造的PPE物品可以在整個(gè)內(nèi)部市場(chǎng)自由流通，成員國(guó)不得對(duì)此類產(chǎn)品的制造和投放市場(chǎng)引入額外的和不同的要求。
10、93/42 / EEC指令和（EU）2017/745法規(guī)充分協(xié)調(diào)了醫(yī)療器械聯(lián)盟市場(chǎng)的設(shè)計(jì)，制造和銷售規(guī)則，并根據(jù)以下內(nèi)容建立了一些基本要求以及一般安全和性能要求根據(jù)受器械預(yù)期用途支配的特定規(guī)則對(duì)醫(yī)療器械進(jìn)行分類。因此，根據(jù)理事會(huì)指令93/42 / EEC和法規(guī)（EU）2017/745制造的設(shè)備可以在整個(gè)內(nèi)部市場(chǎng)自由流通，成員國(guó)不得對(duì)此類設(shè)備的制造和投放市場(chǎng)引入額外的和不同的要求產(chǎn)品。
11、PPE旨在防止有害生物制劑，如病毒在法規(guī)附件I（EU）四百二十五分之二千零十六為III類，其中包括完全可能導(dǎo)致的風(fēng)險(xiǎn)上市“非常嚴(yán)重的后果，如死亡或不可逆的損害健康 ” 。
12、除非適用特定規(guī)則，否則與非侵入性設(shè)備相關(guān)的醫(yī)療設(shè)備屬于I類。
13、根據(jù)（EU）2016/425號(hào)法規(guī)第8條，為了將PPE產(chǎn)品投放市場(chǎng)，制造商應(yīng)執(zhí)行適用的合格評(píng)定程序，并在符合條件的情況下證明符合適用的基本健康和安全要求按照適當(dāng)?shù)某绦?，貼上CE標(biāo)志。
14、根據(jù)指令93/42 / EEC的第11條和（EU）2017/745法規(guī)的第52條，一旦后者適用，為了將醫(yī)療設(shè)備投放市場(chǎng)，制造商應(yīng)執(zhí)行適用的合格評(píng)定程序并且，如果通過(guò)適當(dāng)?shù)某绦蜃C明符合適用的基本要求或一般安全和性能要求，請(qǐng)貼上CE標(biāo)志。會(huì)員國(guó)可應(yīng)正當(dāng)理由要求批準(zhǔn)從合格評(píng)定程序中減損，以便在有關(guān)會(huì)員國(guó)領(lǐng)土內(nèi)投放市場(chǎng)并在使用中保護(hù)受保護(hù)的單個(gè)設(shè)備健康。
15、法規(guī)（EU）2016/425在技術(shù)上是中立的，沒(méi)有為PPE產(chǎn)品的設(shè)計(jì)規(guī)定任何特定的強(qiáng)制性技術(shù)解決方案。相反，法規(guī)（EU）2016/425的附件II規(guī)定了基本的健康和安全要求，PPE應(yīng)該滿足這些基本要求，以便能夠投放市場(chǎng)并在整個(gè)歐盟市場(chǎng)上自由流通。
16、93/42 / EEC指令和法規(guī)（EU）2017/745在技術(shù)上是中立的，沒(méi)有為醫(yī)療設(shè)備的設(shè)計(jì)規(guī)定任何特定的強(qiáng)制性技術(shù)解決方案。相反，指令93/42 / EEC的附件I設(shè)置了基本要求，法規(guī)（EU）2017/745的附件I設(shè)置了一般安全性和性能要求，醫(yī)療設(shè)備應(yīng)滿足這些要求才能將其放置在市場(chǎng)，并在整個(gè)歐盟市場(chǎng)上自由流通。
17、（EU）2016/425號(hào)法規(guī)第14條為制造商提供了依賴特定技術(shù)解決方案的可能性，這些解決方案在統(tǒng)一標(biāo)準(zhǔn)或其部分中進(jìn)行了詳細(xì)說(shuō)明，其參考文獻(xiàn)已在《歐盟官方雜志》上發(fā)表。根據(jù)本條，如果制造商選擇采用這樣的技術(shù)解決方案，則假定個(gè)人防護(hù)設(shè)備符合上述統(tǒng)一標(biāo)準(zhǔn)或其部分所涵蓋的基本健康和安全要求。但是，并非必須遵守協(xié)調(diào)標(biāo)準(zhǔn)。制造商可以自由選擇其他技術(shù)解決方案，前提是保留的特定解決方案可確保PPE符合適用的基本健康和安全要求。
18、指令93/42 / EEC的第5條和法規(guī)（EU）2017/745的第8條為制造商提供了依賴特定技術(shù)解決方案的可能性，這些解決方案在統(tǒng)一標(biāo)準(zhǔn)或其部分中作了詳細(xì)說(shuō)明，其參考文獻(xiàn)已在歐盟官方雜志。根據(jù)本條，如果制造商選擇采用這種技術(shù)解決方案，則假定醫(yī)療器械符合上述協(xié)調(diào)標(biāo)準(zhǔn)或其部分所涵蓋的要求。但是，并非必須遵守協(xié)調(diào)標(biāo)準(zhǔn)。制造商可以自由選擇其他技術(shù)解決方案，前提是保留的特定解決方案可確保醫(yī)療設(shè)備符合適用的基本健康和安全要求。
19、（EU）2016/425號(hào)法規(guī)第19條規(guī)定了具體的合格評(píng)定程序，該程序適用于不同類別的PPE。根據(jù)本條，第三類個(gè)人防護(hù)裝備的項(xiàng)目，例如旨在防止有害生物制劑的項(xiàng)目，應(yīng)進(jìn)行合格評(píng)定程序的特定組合，分別在同一法規(guī)的附件V，VII和VIII中進(jìn)行描述?？赡苁褂玫拿糠N不同的合格評(píng)定程序都需要第三方合格評(píng)定機(jī)構(gòu)的強(qiáng)制參與。
20、93/42 / EEC指令的第11條和法規(guī)（EU）2017/745的第52條一旦適用，就制定適用于不同類別醫(yī)療設(shè)備的特定合格評(píng)定程序。根據(jù)這些條款，屬于第一類的醫(yī)療設(shè)備（定制或研究用設(shè)備除外）應(yīng)接受EC合格聲明的合格評(píng)定程序，而無(wú)需第三方合格評(píng)定機(jī)構(gòu)的參與。
21、公告機(jī)構(gòu)是成員國(guó)指定的合格評(píng)定機(jī)構(gòu)，并有權(quán)執(zhí)行法規(guī)（EU）2016/425中的第三方合格評(píng)定任務(wù)。根據(jù)第（EU）2016/425號(hào)法規(guī)第26條第4款和附件V第7點(diǎn)（f）的規(guī)定，指定機(jī)構(gòu)必須評(píng)估PPE產(chǎn)品是否符合適用的基本健康和安全要求。認(rèn)證機(jī)構(gòu)不僅需要在制造商采用統(tǒng)一標(biāo)準(zhǔn)的地方進(jìn)行評(píng)估，還需要在制造商遵循其他技術(shù)解決方案的情況下進(jìn)行評(píng)估。交付合格評(píng)定證書(shū)時(shí)，指定機(jī)構(gòu)必須通知其通知當(dāng)局，也可能需要將其簽發(fā)的證書(shū)通知其他指定機(jī)構(gòu)，
22、因此，公告機(jī)構(gòu)應(yīng)評(píng)估根據(jù)其他技術(shù)解決方案生產(chǎn)的產(chǎn)品（例如，世衛(wèi)組織關(guān)于適當(dāng)選擇個(gè)人防護(hù)裝備的建議中所包含的產(chǎn)品）是否也符合適用的基本健康和安全要求?？紤]到確保個(gè)人防護(hù)裝備供應(yīng)鏈中所有利益相關(guān)者之間有效信息交換的重要性，公告機(jī)構(gòu)得出結(jié)論認(rèn)為，遵循另一項(xiàng)特定標(biāo)準(zhǔn)或技術(shù)解決方案的個(gè)人防護(hù)裝備符合適用于其的基本健康和安全要求，這些信息將有助于快速評(píng)估根據(jù)同一特定標(biāo)準(zhǔn)或技術(shù)解決方案生產(chǎn)的其他產(chǎn)品。為此，
23、此外，根據(jù)法規(guī)（EU）2016/425中的相關(guān)市場(chǎng)監(jiān)督程序，尤其是其中的第38（1）和（2）條，如果市場(chǎng)監(jiān)督機(jī)構(gòu)遇到非CE標(biāo)志的PPE產(chǎn)品，則需要對(duì)其進(jìn)行評(píng)估它。市場(chǎng)評(píng)估機(jī)構(gòu)在評(píng)估過(guò)程中發(fā)現(xiàn)個(gè)人防護(hù)設(shè)備不符合本規(guī)章的要求時(shí)，應(yīng)要求經(jīng)濟(jì)經(jīng)營(yíng)者采取糾正措施以使個(gè)人防護(hù)設(shè)備符合要求或召回或撤回它，與風(fēng)險(xiǎn)的性質(zhì)相稱。他們還應(yīng)將評(píng)估結(jié)果以及他們要求經(jīng)濟(jì)經(jīng)營(yíng)者采取的行動(dòng)告知委員會(huì)和其他成員國(guó)。
24、因此，為了解決在COVID-19爆發(fā)時(shí)（非CE標(biāo)志的PPE打算進(jìn)入歐盟市場(chǎng)）所必需的PPE短缺的問(wèn)題，相關(guān)的市場(chǎng)監(jiān)督機(jī)構(gòu)應(yīng)對(duì)產(chǎn)品進(jìn)行評(píng)估，如果發(fā)現(xiàn)這些產(chǎn)品屬于符合相關(guān)法規(guī)所規(guī)定的基本健康與安全要求的人員，應(yīng)采取措施，在有限的時(shí)間內(nèi)或在與指定機(jī)構(gòu)進(jìn)行合格評(píng)定程序的同時(shí)，將此類PPE投放到歐盟市場(chǎng)。為了確?？梢栽谄渌麜?huì)員國(guó)提供此類產(chǎn)品，并考慮到確保有效交換信息以及對(duì)對(duì)公民健康和安全的所有威脅作出協(xié)調(diào)反應(yīng)的重要性，
25、考慮到在COVID-19爆發(fā)中使用的某些類型的PPE或醫(yī)療設(shè)備也可能用于其他目的，有必要使會(huì)員國(guó)采取一切適當(dāng)措施，以確保不攜帶PPE或醫(yī)療設(shè)備的醫(yī)療設(shè)備。根據(jù)本建議書(shū)第8段可以在歐盟市場(chǎng)上投放的CE標(biāo)記僅提供給醫(yī)護(hù)人員，
通過(guò)了此建議：
1.為了確保在COVID-19爆發(fā)中提供個(gè)人防護(hù)設(shè)備和醫(yī)療設(shè)備以提供適當(dāng)?shù)谋Ｗo(hù)，委員會(huì)邀請(qǐng)整個(gè)供應(yīng)鏈中的所有經(jīng)濟(jì)運(yùn)營(yíng)商以及指定機(jī)構(gòu)和市場(chǎng)監(jiān)督機(jī)構(gòu)在其部署中采取所有措施處置以支持旨在確保整個(gè)歐盟市場(chǎng)的個(gè)人防護(hù)設(shè)備和醫(yī)療設(shè)備的供應(yīng)與不斷增長(zhǎng)的需求相匹配的工作。但是，此類措施不應(yīng)對(duì)整體健康和安全水平產(chǎn)生不利影響，所有相關(guān)利益相關(guān)方應(yīng)確保投放到歐盟市場(chǎng)的任何個(gè)人防護(hù)設(shè)備或醫(yī)療設(shè)備繼續(xù)為用戶提供足夠的保護(hù)水平' 健康和安全。
合格評(píng)定程序
2、根據(jù)（EU）2016/425號(hào)條例的指定機(jī)構(gòu)，應(yīng)優(yōu)先考慮并迅速進(jìn)行PPE經(jīng)濟(jì)運(yùn)營(yíng)商在保護(hù)COVID-19時(shí)應(yīng)保護(hù)的PPE經(jīng)濟(jì)運(yùn)營(yíng)商所有新提交的要求中的合格評(píng)定活動(dòng)。
3、對(duì)于遵循非統(tǒng)一標(biāo)準(zhǔn)的技術(shù)解決方案生產(chǎn)的PPE產(chǎn)品，只要這些技術(shù)解決方案確保足夠的保護(hù)水平，WHO關(guān)于適當(dāng)選擇PPE的建議可以用作此類技術(shù)解決方案的潛在參考來(lái)源。符合法規(guī)（EU）2016/425規(guī)定的適用基本健康與安全要求。
4、向遵循統(tǒng)一標(biāo)準(zhǔn)以外的其他技術(shù)解決方案生產(chǎn)的PPE產(chǎn)品頒發(fā)證書(shū)的認(rèn)證機(jī)構(gòu)，應(yīng)立即將其頒發(fā)的證書(shū)和遵循的具體技術(shù)解決方案通知相關(guān)的通報(bào)機(jī)構(gòu)以及根據(jù)（EU）2016/425條的其他認(rèn)證機(jī)構(gòu)。公告機(jī)構(gòu)應(yīng)通過(guò)根據(jù)法規(guī)（EU）2016/425第36條成立的公告機(jī)構(gòu)小組的協(xié)調(diào)來(lái)交換此類信息。
5，就醫(yī)療器械而言，根據(jù)指令93/42 / EEC第11（13）條和法規(guī)（EU）2017/745的第59條，還應(yīng)考慮成員國(guó)授權(quán)從合格評(píng)定程序中減損的可能性。后者在不需要指定機(jī)構(gòu)介入的情況下也適用。
市場(chǎng)監(jiān)督程序
6、成員國(guó)的相關(guān)市場(chǎng)監(jiān)督機(jī)構(gòu)應(yīng)優(yōu)先關(guān)注不合規(guī)的個(gè)人防護(hù)設(shè)備或醫(yī)療設(shè)備，這些設(shè)備會(huì)對(duì)其預(yù)期用戶的健康和安全造成嚴(yán)重風(fēng)險(xiǎn)。
7、市場(chǎng)監(jiān)督機(jī)構(gòu)發(fā)現(xiàn)PPE或醫(yī)療設(shè)備可確保根據(jù)（EU）2016/425法規(guī)或93/42 / EEC指令或2017（EU）法規(guī)的基本要求確保足夠的健康和安全水平/ 745，即使尚未按照協(xié)調(diào)規(guī)則完全完成包括CE標(biāo)志在內(nèi)的合格評(píng)定程序，它們?nèi)钥梢允跈?quán)在限定的時(shí)間內(nèi)在歐盟市場(chǎng)上提供這些產(chǎn)品程序正在執(zhí)行中。
8、不帶CE標(biāo)志的PPE或醫(yī)療設(shè)備也可以進(jìn)行評(píng)估，并由相關(guān)成員國(guó)當(dāng)局組織購(gòu)買(mǎi)的一部分，前提是要確保此類產(chǎn)品僅在當(dāng)前健康危機(jī)期間可供醫(yī)護(hù)人員使用，并確保它們沒(méi)有進(jìn)入常規(guī)分銷渠道，并可供其他用戶使用。
9、市場(chǎng)監(jiān)督機(jī)構(gòu)應(yīng)立即將其授予特定PPE或醫(yī)療設(shè)備的任何臨時(shí)安排告知委員會(huì)和其他成員國(guó)。對(duì)于個(gè)人防護(hù)設(shè)備，應(yīng)通過(guò)用于市場(chǎng)監(jiān)視的信息和通信系統(tǒng)（ICSMS）來(lái)完成。
歐盟成員國(guó)名單（27國(guó)）：
奧地利、比利時(shí)、保加利亞、塞浦路斯、捷克、克羅地亞、丹麥、愛(ài)沙尼亞、芬蘭、法國(guó)、德國(guó)、希臘、匈牙利、愛(ài)爾蘭、意大利、拉脫維亞、羅馬尼亞、立陶宛、盧森堡、馬耳他、荷蘭、波蘭、葡萄牙、斯洛伐克、斯洛文尼亞、西班牙、瑞典。
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