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欧盟:COVID-19相关医疗器械和个人防护用品应急建议发布!

新冠病毒全球大流行,欧盟委员会对于防护眼镜、口罩、防护服等用品的进口开启了应急审批程序。

 

以下是 Commission Recommendation (EU) 2020/403 of 13 March 2020的中英文对照,供参考 :

 

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.

 

为了在COVID-19爆发时确保公众可获得充分的个人防护用品和医疗器械,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,努力采取所有可行的措施,以确保整个欧盟市场的个人防护用品和医疗器械供应,与不断增长的需求相匹配。然而,此类措施不应对整体健康和安全水平产生不利影响,所有利益相关者应确保任何正在投放欧盟市场的个人防护用品或医疗器械持续为用户的健康和安全提供充分的保护。

 

01

CONFORMITY ASSESSMENT PROCEDURE

符合性评估程序

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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.

 

(EU) 2016/425法规授权公告机构,应针对PPE经济运营商所有新提交的,涉及COVID-19爆发情况下的必须PPE防护设备的申请,优先考虑并迅速开展合规性评估活动。

 

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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.

 

对于按照协调标准以外的技术方案生产的个人防护用品,世卫组织关于适当选择个人防护用品的建议,可作为此类技术方案的参考源,前提是上述技术方案确保了足够满足(EU) 2016/425法规规定的基本健康和安全保护要求。

 
 

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.

 

如有公告机构,对协调标准以外的技术方案生产的PPE产品颁发了证书,该机构应当立即将采用的技术方案,通知到相关当局以及其他(EU) 2016/425 PPE法规授权公告机构。公告机构应当通过(EU) 2016/425法规第36条设立的公告机构协调组来交换此类信息。

 

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.

 

对于医疗器械,还应根据指令93/42/EEC第11(13)条和法规(EU)2017/745第59条的规定,考虑成员国授权减免符合性评估程序的可行性,包括不需要公告机构介入评估的情况。

 

02

MARKET SURVEILLANCE PROCEDURES

市场监督程序

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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.

 

欧盟成员国的市场监督机构,应优先关注不符合要求的个人防护用品或医疗器械,这些产品会对用户的健康和安全造成严重风险。

 

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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.

 

如果市场监督机构确定,个人防护用品或医疗器械能够充分满足(EU) 2016/425 法规、或93/42/EEC指令和(EU) 2017/745法规的基本健康和安全要求;那么即使不能完整完成符合性评估程序,包括未能按要求粘贴CE标识,它们也可以被授权在有限的时间内投放欧盟市场,只要规定的符合性评估程序同步在公告机构进行中。

 

 

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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.

 

如果是作为欧盟成员国当局组织的采购的个人防护用品或医疗器械,即使不带CE标志,也可进行评估考虑,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,且不进入常规市场销售渠道并提供给其他用户。

 

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).

 

市场监督机构应立即通知欧盟委员会和其他成员国,其对特定个人防护用品或医疗器械的任何临时措施。对于个人防护用品,应通过市场监督信息和交流系统(ICSMS)进行。

 
 
 
 
 
 
 
 

 

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