口罩CE認(rèn)證！歐盟官方通告、政策重點(diǎn)解說(shuō)、認(rèn)證資格查驗(yàn)

2020/3/24 19:11:00 來(lái)源: 評(píng)論(0)12509

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面對(duì)新冠疫情，為滿(mǎn)足口罩、防護(hù)服等防疫用品日益增長(zhǎng)的需求，歐盟開(kāi)啟綠色通道，無(wú)需CE標(biāo)識(shí)，可進(jìn)入歐盟，供醫(yī)療工作者使用。允許部分防疫物資（如一類(lèi)滅菌的醫(yī)用口罩）在符合安全有效的情況下，即使尚未獲得CE認(rèn)證，也可以在歐盟市場(chǎng)上市銷(xiāo)售。

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。

◆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(xiāo)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。

個(gè)人防護(hù)用品（PPE）方面：

◆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(lèi)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)。

◆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(xiāo)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)。

重點(diǎn)如下?。?！

◆緊急物資專(zhuān)供醫(yī)療人員使用，不可在市場(chǎng)上流通；

關(guān)于CE標(biāo)識(shí)

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(mǎn)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。

出口各國(guó)推薦閱讀：史上最詳盡！口罩出口通關(guān)申報(bào)官方指南

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。

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。

01、貴司是否為NB機(jī)構(gòu)? 機(jī)構(gòu)號(hào)是否可以查詢(xún)？

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)，今天Mike將歐盟通告原文貼出，大家可以自己好好研究一下每種標(biāo)準(zhǔn)的具體陳述；昨天給了鏈接后，很多人說(shuō)打不開(kāi)網(wǎng)頁(yè)，其實(shí)應(yīng)該是你們的局域網(wǎng)問(wèn)題，不過(guò)沒(méi)關(guān)系，我給你們貼出來(lái)：

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:

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,

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

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.

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.

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.

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.

Done at Brussels, 13 March 2020.

Thierry BRETON

原文查看（實(shí)在打不開(kāi)的，建議換瀏覽器或電腦試試）：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：

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。

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）。

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。

8、在發(fā)生COVID-19威脅的情況下，此類(lèi)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。

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(xiāo)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(lèi)。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(lèi)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。

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(lèi)。

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。

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(mǎn)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。

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(lài)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。

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(lèi)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(lèi)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。

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，

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(lèi)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(lèi)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，

通過(guò)了此建議：

合格評(píng)定程序

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(hù)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(lèi)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(xiāo)渠道，并可供其他用戶(hù)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。

<span style="font-family:SimSun;font-size:16px;color:#d92142;margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;Helvetica Neue", Helvetica, "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif;">附：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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