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EU: Tolerant CE policy, green channel for epidemic prevention supplies

Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

2020.3.13日欧盟发布了COVID-19威胁范围内的合格评定和市场监督程序的(EU)2020/403建议。

整个建议书的核心是为了满足欧盟市场对个人防护设备(“ PPE”)(例如口罩,手套,防护工作服或护目镜)和医疗器械(例如口罩,探查手套和某些长袍)的日益增长的需求。

该建议书规定,在特定情况下,某些医疗器械和PPE可能会在COVID-19爆发的情况下在欧盟市场上出售,即使它们尚未贴有CE标志,表明其符合适用的法规和义务。

The Recommendation provides that under specific circumstances some medical devices and PPE may be made available on the EU market within the context of the COVID-19 outbreak, even if they do not yet bear the CE mark demonstrating conformity with applicable regulations and obligations.

欧盟:宽容的CE政策,对防疫用品的绿色通道 第1张

欧洲的官方文件说明喜欢用长句,句子长,非常不好断句,内容有些詰屈聱牙,个人理解会可能有一些偏差,非常清楚熟悉这个条款的欢迎下面直接留言,或者加我微信15019262980。看不懂英文的话可以看翻译,后面不翻译了,直接陈述重点。

01

背景陈述

1.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.

在当前的COVID-19全球爆发以及病毒在欧盟各个地区的快速传播的背景下,对个人防护设备(以下称“ PPE”)的需求,例如口罩,手套,防护工作服或眼镜防护以及用于外科口罩,探查手套和某些礼服等医疗设备的数量呈指数增长。特别是,由于通过现有渠道以及通过新渠道的需求呈指数增长,某些类型的PPE(例如一次性口罩)的供应链承受着巨大的压力。

In addition, the global supply chain of such products has also sustained significant disruptions,which have induced repercussions on the EU market as well.此外,此类产品的全球供应链也遭受了严重破坏,这也引起了欧盟市场的反响。

02

原则

2. 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.

牢记欧盟公民的健康和安全是重中之重,因此,确保最需要的人迅速获得最适当的个人防护设备和医疗设备,以确保获得足够的保护,这一点至关重要。

注意:关于法规的条款没有写,可以看原文(4)(5).

03

应用

(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,这个EU 425就是PPE法规,针对个人防护用品。

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.

(7)外科口罩,检查手套和某些长袍类型的产品属于93/42 / EEC指令和2017/745法规(EU)的范围。这些产品在医疗器械法规中都是class I.

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.

(8)(9)(10)三条合计一句话:防疫物资非常重要,你们按照我的规定的法规统一执行就可以了,每个成员国不要各自为政,实行不同的政策!

(8)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.

(9)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.

(10)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.

(23)(24)(25)这三点是说非CE标志的PPE打算进入欧盟市场时,市场监管机构应该对其进行监管,以使个人防护设备符合要求或召回或撤回它。

(23)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.

(24)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.

(25)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.

04

合法评定程序

2-4这三点阐述的是,防护用品生产技术不是统一的标准,倘若技术确定防护可以到一定的水平,WHO也是推荐这些的产品作为当下应对的解决方案产品。

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.

05

市场监督程序

6 7 8也是文件想要传达的主旨:

a.不合格产品严厉监管,

b.按法规可保证足够健康安全水平的产品,即使没有完成CE评定流程,限期可以上市。

C.市场监管部门要对不带CE的产品或设备进行评估,确保仅在疫情期间供医护人员使用,不能进入常规销售渠道流通。紧急物资主要是给专业的医疗人员使用。

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).

不同的人解读之下会有一定的偏差,

现在疫情之下欧洲对口罩需求量猛增,

除了发货的运费贵速度慢之外,

还有目的地海关政策。


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