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之間，新冠肺炎防護(hù)產(chǎn)品“無需認(rèn)證直接發(fā)貨”等說法擠滿網(wǎng)站、朋友圈。本文不打算私揣測甚至解讀該推薦書的本意，僅將

（EU）2020/403推薦書原文呈現(xiàn)，并附中文翻譯，以供業(yè)內(nèi)外朋友自度。

以下為原文：（翻譯來自卓遠(yuǎn)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 歐盟委員會 關(guān)于在COVID-19威脅背景之下 合格評定和市場監(jiān)督程序的推薦（EU）2020/403

THEEUROPEAN COMMISSION,

歐盟委員會，

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

考慮到《歐洲聯(lián)盟運作條約》，特別是其第292條，

Whereas:鑒于：

（1）~（25）（略去）

HASADOPTED THIS RECOMMENDATION: 已采用此推薦：

1 .Withthe objective to ensure availability of PPE and medical devices for adequateprotection in the COVID-19 outbreak, 

theCommission 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）為了確保在COVID-19爆發(fā)中提供個人防護(hù)設(shè)備和醫(yī)療設(shè)備以提供充分保護(hù)，歐盟委員會邀請整個供應(yīng)鏈中的所有經(jīng)濟(jì)運

營商以及公告機(jī)構(gòu)和市場監(jiān)督機(jī)構(gòu)，盡可能采取所有可能的措施，以支持旨在確保整個歐盟市場的個人防護(hù)設(shè)備和醫(yī)療器械的供

應(yīng)與不斷增長的需求相匹配。但是，此類措施不應(yīng)對整體健康和安全水平產(chǎn)生不利影響，所有的利益相關(guān)方應(yīng)確保投放到歐盟市

場的任何個人防護(hù)設(shè)備或醫(yī)療設(shè)備持續(xù)為用戶健康和安全提供足夠的保護(hù)水平。

CONFORMITY ASSESSMENT PROCEDURES

符合性評定程序

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 theco-

ntext of the COVID-19 outbreak.

 2）（EU）2016/425條例的公告機(jī)構(gòu)，應(yīng)優(yōu)先考慮并迅速處理COVID-19背景下必需的個人防護(hù)設(shè)備的經(jīng)濟(jì)運營商新近提出的

符合性評定活動。

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）對于按照技術(shù)解決方案而非協(xié)調(diào)標(biāo)準(zhǔn)制造的個人防護(hù)裝備產(chǎn)品，世衛(wèi)組織關(guān)于適當(dāng)選擇個人防護(hù)裝備的建議可以用作此類

技術(shù)解決方案的潛在參考來源，前提是上述技術(shù)解決方案必須確保（EU）2016/425條例規(guī)定的適用基本健康和安全要求的保護(hù)措

施達(dá)到適當(dāng)?shù)乃健?/p>

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）頒發(fā)證書給未按協(xié)調(diào)標(biāo)準(zhǔn)制造而是按照技術(shù)解決方案制造的個人防護(hù)設(shè)備的公告機(jī)構(gòu)，應(yīng)立即通知相關(guān)的公告授權(quán)者以及

根據(jù)（EU）2016/425條例頒發(fā)證書且遵循具體技術(shù)方案的其他公告機(jī)構(gòu)。公告機(jī)構(gòu)應(yīng)通過根據(jù)法規(guī)（EU）2016/425第36條成立

的公告機(jī)構(gòu)小組的協(xié)調(diào)來交換此類信息。

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）對于醫(yī)療器械，根據(jù)93/42 / EEC指令第11（13）條和（EU）2017 / 745條例第59條，一旦后者適用，應(yīng)考慮成員國授權(quán)減損

合格評定程序的可能性，這也適用于不需要公告機(jī)構(gòu)干預(yù)時。

MARKET SURVEILLANCE PROCEDURES

市場監(jiān)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）成員國的相關(guān)市場監(jiān)督機(jī)構(gòu)應(yīng)優(yōu)先關(guān)注對其預(yù)期用戶的健康和安全造成嚴(yán)重風(fēng)險的不合規(guī)的個人防護(hù)設(shè)備或醫(yī)療設(shè)備。

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）市場監(jiān)督機(jī)構(gòu)發(fā)現(xiàn)，根據(jù)（EU）2016/425條例或93/42 / EEC指令或（EU）2017/745條例的基本要求，個人防護(hù)設(shè)備或醫(yī)療器

械可確保足夠的健康和安全水平，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)的合格評定程序，它們?nèi)钥梢允跈?quán)在限定的時間內(nèi)，

且在必需的程序執(zhí)行過程中，向歐盟市場上提供這些產(chǎn)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）不帶CE標(biāo)志的個人防護(hù)設(shè)備或醫(yī)療器械也可以進(jìn)行評定，部分的采購可由相關(guān)成員國當(dāng)局組織，前提是確保此類產(chǎn)品僅在當(dāng)前

健康危機(jī)期間供醫(yī)護(hù)人員使用，并且這些產(chǎn)品沒有進(jìn)入常規(guī)銷售渠道，也無法提供給其他用戶。

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）市場監(jiān)督機(jī)構(gòu)應(yīng)立即將其已同意特定的個人防護(hù)設(shè)備或醫(yī)療器械的任何臨時安排告知歐盟委員會和其他成員國。對于個人防護(hù)設(shè)

備，這應(yīng)通過市場監(jiān)督的信息和通信系統(tǒng)來完成。

                                                                                                                                                    Doneat Brussels, 13 March 2020.

                                                                                                                                                    完成于布魯塞爾， 2020年3月13日

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