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口罩CE认证!欧盟官方通告、政策重点解说、认证资格查验

2020/3/24 19:11:00 来源: 评论(0)2

口罩CE认证欧盟

面对新冠疫情,为满足口罩、防护服等防疫用品日益增长的需求,欧盟开启绿色通道,无需CE标识,可进入欧盟,供医疗工作者使用。允许部分防疫物资(如一类灭菌的医用口罩)在符合安全有效的情况下,即使尚未获得CE认证,也可以在欧盟市场上市销售。


2020年3月13日,欧盟会员会在欧洲官方杂志( Official Journal of the EuropeanUnion)发布了疫情期间针对医疗器械和个人防护用品 (PPE)的符合性评价和市场监督程序的建议。


◆如果市场监督机构确定产品符合医疗器械的基本安全和性能要求,即使其符合性评价还未完成,市场监督机构可以允许其在一定的时间内进行销售,同时该产品必须继续完成其符合性评价过程。


个人防护用品(PPE)方面:


◆应急审批产品如果不采用PPE法规协调标准作为产品技术要求而采用其它技术要求,比如WHO的推荐要求,须确保采用的技术要求与PPE法规基本健康与安全要求同等防护水平。公告机构对这类采用其它技术要求的PPE产品进行发证时,需要立即通知主管当局和其它PPE法规的公告机构。


◆成员国主管当局也可在疫情期间评估和组织采购没有CE标记的PPE产品,该产品仅可提供给医疗工作者使用,不能在市场上流通销售。同时市场抽查将会重点抽查防疫相关PPE产品,以防止不合格产品导致严重风险。


重点如下!!!


◆紧急物资专供医疗人员使用,不可在市场上流通;


关于CE标识


如今CE标识已经成为了全球认可的质量标志,CE标志可以证明该批在欧盟制作或进口至欧盟成员国的产品符合质量标准,满足保护消费者健康、供应链安全和环境可持续发展的要求。


出口各国推荐阅读史上最详尽!口罩出口通关申报官方指南


在欧盟,口罩属于PPE个人防护用品,“危及健康的物质和混合物”。2019年起,欧盟新法规PPE Regulation (EU) 2016/425强制执行,所有出口欧盟的口罩必须在新法规的要求下获得CE认证证书。CE认证证书的有效期是5年左右,一般费用是10000-15000元人民币。


FFP2口罩与上文提到的医用防护口罩、KN95口罩、N95口罩过滤效率十分接近。医疗口罩必须遵循BSEN14683标准,可以分为三个等级:低标准Type、然后是Type和TypeR。上一个版本是BSEN146832014,已被新版BSEN146832019所取代。EN 14683:2019年版主要的变化之一是压力差,Type、Type、TypeR压力差分别由2014年版的29.4、29.4、49.0Pa/cm,上升至40、40、60Pa/cm。


01、贵司是否为NB机构? 机构号是否可以查询?

近期,大家都在对口罩等医疗物资的欧盟标准犯愁,都是一知半解的状态,今天Mike将欧盟通告原文贴出,大家可以自己好好研究一下每种标准的具体陈述;昨天给了链接后,很多人说打不开网页,其实应该是你们的局域网问题,不过没关系,我给你们贴出来:


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:

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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(实在打不开的,建议换浏览器或电脑试试):COVID-19威胁范围内的合格评定和市场监督程序

欧洲委员会,考虑到《欧洲联盟运作条约》,特别是其第292条,鉴于:


2、牢记欧盟公民的健康和安全是重中之重,因此,确保向最需要的人迅速提供最适当的个人防护设备和医疗设备,以确保提供足够的保护,这一点至关重要。


4、有关个人防护设备的设计,制造和投放市场的要求,由欧洲议会和理事会于2016年3月9日颁布的第(EU)2016/425号条例(关于个人防护设备)以及废除理事会第89/686号指令规定/ EEC  (1)。


6、一次性和可重复使用的口罩,可防止颗粒物危害,一次性和可重复使用的工作服,手套和眼镜防护,用于预防和防止有害生物制剂(如病毒)属于本法规范围内的产品(欧盟)2016/425。


8、在发生COVID-19威胁的情况下,此类PPE和医疗设备对于参与遏制病毒并避免其进一步传播的医护人员,急救人员和其他人员至关重要。


10、93/42 / EEC指令和(EU)2017/745法规充分协调了医疗器械联盟市场的设计,制造和销售规则,并根据以下内容建立了一些基本要求以及一般安全和性能要求根据受器械预期用途支配的特定规则对医疗器械进行分类。因此,根据理事会指令93/42 / EEC和法规(EU)2017/745制造的设备可以在整个内部市场自由流通,成员国不得对此类设备的制造和投放市场引入额外的和不同的要求产品。


12、除非适用特定规则,否则与非侵入性设备相关的医疗设备属于I类。


14、根据指令93/42 / EEC的第11条和(EU)2017/745法规的第52条,一旦后者适用,为了将医疗设备投放市场,制造商应执行适用的合格评定程序并且,如果通过适当的程序证明符合适用的基本要求或一般安全和性能要求,请贴上CE标志。会员国可应正当理由要求批准从合格评定程序中减损,以便在有关会员国领土内投放市场并在使用中保护受保护的单个设备健康。


16、93/42 / EEC指令和法规(EU)2017/745在技术上是中立的,没有为医疗设备的设计规定任何特定的强制性技术解决方案。相反,指令93/42 / EEC的附件I设置了基本要求,法规(EU)2017/745的附件I设置了一般安全性和性能要求,医疗设备应满足这些要求才能将其放置在市场,并在整个欧盟市场上自由流通。


18、指令93/42 / EEC的第5条和法规(EU)2017/745的第8条为制造商提供了依赖特定技术解决方案的可能性,这些解决方案在统一标准或其部分中作了详细说明,其参考文献已在欧盟官方杂志。根据本条,如果制造商选择采用这种技术解决方案,则假定医疗器械符合上述协调标准或其部分所涵盖的要求。但是,并非必须遵守协调标准。制造商可以自由选择其他技术解决方案,前提是保留的特定解决方案可确保医疗设备符合适用的基本健康和安全要求。


20、93/42 / EEC指令的第11条和法规(EU)2017/745的第52条一旦适用,就制定适用于不同类别医疗设备的特定合格评定程序。根据这些条款,属于第一类的医疗设备(定制或研究用设备除外)应接受EC合格声明的合格评定程序,而无需第三方合格评定机构的参与。


22、因此,公告机构应评估根据其他技术解决方案生产的产品(例如,世卫组织关于适当选择个人防护装备的建议中所包含的产品)是否也符合适用的基本健康和安全要求。考虑到确保个人防护装备供应链中所有利益相关者之间有效信息交换的重要性,公告机构得出结论认为,遵循另一项特定标准或技术解决方案的个人防护装备符合适用于其的基本健康和安全要求,这些信息将有助于快速评估根据同一特定标准或技术解决方案生产的其他产品。为此,


24、因此,为了解决在COVID-19爆发时(非CE标志的PPE打算进入欧盟市场)所必需的PPE短缺的问题,相关的市场监督机构应对产品进行评估,如果发现这些产品属于符合相关法规所规定的基本健康与安全要求的人员,应采取措施,在有限的时间内或在与指定机构进行合格评定程序的同时,将此类PPE投放到欧盟市场。为了确保可以在其他会员国提供此类产品,并考虑到确保有效交换信息以及对对公民健康和安全的所有威胁作出协调反应的重要性,


通过了此建议:


合格评定程序


 

 

 

市场监督程序

6、成员国的相关市场监督机构应优先关注不合规的个人防护设备或医疗设备,这些设备会对其预期用户的健康和安全造成严重风险。

7、市场监督机构发现PPE或医疗设备可确保根据(EU)2016/425法规或93/42 / EEC指令或2017(EU)法规的基本要求确保足够的健康和安全水平/ 745,即使尚未按照协调规则完全完成包括CE标志在内的合格评定程序,它们仍可以授权在限定的时间内在欧盟市场上提供这些产品程序正在执行中。

8、不带CE标志的PPE或医疗设备也可以进行评估,并由相关成员国当局组织购买的一部分,前提是要确保此类产品仅在当前健康危机期间可供医护人员使用,并确保它们没有进入常规分销渠道,并可供其他用户使用。

9、市场监督机构应立即将其授予特定PPE或医疗设备的任何临时安排告知委员会和其他成员国。对于个人防护设备,应通过用于市场监视的信息和通信系统(ICSMS)来完成。










<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:欧盟成员国名单(27国):




奥地利、比利时、保加利亚、塞浦路斯、捷克、克罗地亚、丹麦、爱沙尼亚、芬兰、法国、德国、希腊、匈牙利、爱尔兰、意大利、拉脱维亚、罗马尼亚、立陶宛、卢森堡、马耳他、荷兰、波兰、葡萄牙、斯洛伐克、斯洛文尼亚、西班牙、瑞典。

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