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欧盟绿色通道,到底长啥样儿

2020年3月13日,欧盟委员会发布(EU)2020/403推荐书,该推荐书被业内誉为新冠肺炎条件下的欧盟绿色通道。一时之间,新冠肺炎防护产品“无需认证直接发货”等说法挤满网站、朋友圈。本文不打算私揣测甚至解读该推荐书的本意,仅将(EU)2020/403推荐书原文呈现,并附中文翻译,以供业内外朋友自度。

以下为原文:(翻译来自卓远天成)

COMMISSIONRECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment andmarket surveillance procedures within the context of the COVID-19 threat

2020年3月13日 欧盟委员会 关于在COVID-19威胁背景之下 合格评定和市场监督程序的推荐(EU)2020/403

THEEUROPEAN COMMISSION,

欧盟委员会,

Havingregard to the Treaty on the Functioning of the European Union, and inparticular Article 292 thereof,

考虑到《欧洲联盟运作条约》,特别是其第292条,

Whereas:鉴于:

(1)~(25)(略去)

HASADOPTED THIS RECOMMENDATION: 已采用此推荐:

1 .Withthe objective to ensure availability of PPE and medical devices for adequateprotection in the COVID-19 outbreak, the Commission invites all economicoperators throughout the supply chain, as well as notified bodies and marketsurveillance authorities to deploy all the measures at their disposal tosupport the efforts aimed at ensuring that the supply of PPE and medicaldevices throughout the EU market will match the continuously increasing demand.Such measures should nevertheless not have a detrimental effect on the overalllevel of health and safety and all relevant stakeholders should ensure that anyPPE or medical devices, which is being placed on the EU market, continues toprovide an adequate level of protection of the users’ health and safety.

1)为了确保在COVID-19爆发中提供个人防护设备和医疗设备以提供充分保护,欧盟委员会邀请整个供应链中的所有经济运营商以及公告机构和市场监督机构,尽可能采取所有可能的措施,以支持旨在确保整个欧盟市场的个人防护设备和医疗器械的供应与不断增长的需求相匹配。但是,此类措施不应对整体健康和安全水平产生不利影响,所有的利益相关方应确保投放到欧盟市场的任何个人防护设备或医疗设备持续为用户健康和安全提供足够的保护水平。

CONFORMITY ASSESSMENT PROCEDURES

符合性评定程序

2. Thenotified bodies under Regulation (EU) 2016/425 should prioritize and swiftlyconduct the conformity assessment activities in the framework of all newlysubmitted requests by economic operators of PPE necessary for protection in thecontext of the COVID-19 outbreak.

2)(EU)2016/425条例的公告机构,应优先考虑并迅速处理COVID-19背景下必需的个人防护设备的经济运营商新近提出的符合性评定活动。

3.In the case of PPE products manufactured following technical solutions otherthan harmonized standards, the WHO recommendations on the appropriate selectionof PPE may be used as a potential source of reference for such technicalsolutions, provided that the said technical solutions ensure an adequate levelof protection corresponding to the applicable essential health and safetyrequirements laid down in Regulation (EU) 2016/425.

3)对于按照技术解决方案而非协调标准制造的个人防护装备产品,世卫组织关于适当选择个人防护装备的建议可以用作此类技术解决方案的潜在参考来源,前提是上述技术解决方案必须确保(EU)2016/425条例规定的适用基本健康和安全要求的保护措施达到适当的水平。

4.Notified bodies which issue certificates to PPE products manufactured followingother technical solutions than harmonized standards, should immediately informthe relevant notifying authority as well as the other notified bodies underRegulation (EU) 2016/425 of the certificates issued and the specific technicalsolution followed. Notified bodies should exchange such information through thecoordination of notified bodies group established under Article 36 ofRegulation (EU) 2016/425.

4)颁发证书给未按协调标准制造而是按照技术解决方案制造的个人防护设备的公告机构,应立即通知相关的公告授权者以及根据(EU)2016/425条例颁发证书且遵循具体技术方案的其他公告机构。公告机构应通过根据法规(EU)2016/425第36条成立的公告机构小组的协调来交换此类信息。

5.In the case of medical devices, the possibility for Member States to authorizederogations 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 ofa notified body is not required.

5)对于医疗器械,根据93/42 / EEC指令第11(13)条和(EU)2017 / 745条例第59条,一旦后者适用,应考虑成员国授权减损合格评定程序的可能性,这也适用于不需要公告机构干预时。

MARKET SURVEILLANCE PROCEDURES

市场监督程序

6 Therelevant market surveillance authorities in the Member States should as amatter of priority focus on non-compliant PPE or medical devices raisingserious risks as to the health and safety of their intended users.

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

7 Wheremarket surveillance authorities find that PPE or medical devices ensure anadequate level of health and safety in accordance with the essentialrequirements laid down in Regulation (EU) 2016/425 or the requirements ofDirective 93/42/EEC or Regulation (EU) 2017/745, even though the conformityassessment procedures, including the affixing of CE marking have not been fullyfinalized according to the harmonized rules, they may authorize the makingavailable of these products on the Union market for a limited period of timeand while the necessary procedures are being carried out.

7)市场监督机构发现,根据(EU)2016/425条例或93/42 / EEC指令或(EU)2017/745条例的基本要求,个人防护设备或医疗器械可确保足够的健康和安全水平,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,且在必需的程序执行过程中,向欧盟市场上提供这些产品。

8. PPEor medical devices not bearing the CE marking could also be assessed and partof a purchase organized by the relevant member state authorities provided thatis ensured that such products are only available for the healthcare workers forthe duration of the current health crisis, and that they are not entering theregular distribution channels and made available to other users.

8)不带CE标志的个人防护设备或医疗器械也可以进行评定,部分的采购可由相关成员国当局组织,前提是确保此类产品仅在当前健康危机期间供医护人员使用,并且这些产品没有进入常规销售渠道,也无法提供给其他用户。

9. Marketsurveillance authorities should inform immediately the commission and othermember states of any temporary arrangement they have granted to specific PPE ormedical devices. for PPE, this should be done through the information andcommunication system for market surveillance (ICSMS)

9)市场监督机构应立即将其已同意特定的个人防护设备或医疗器械的任何临时安排告知欧盟委员会和其他成员国。对于个人防护设备,这应通过市场监督的信息和通信系统来完成。

Doneat Brussels, 13 March 2020.

完成于布鲁塞尔, 2020年3月13日


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