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口罩CE認證!歐盟官方通告、政策重點解說、認證資格查驗

為滿足口罩、防護服等防疫用品日益增長的需求,歐盟開啟綠色通道,無需CE標識,可進入歐盟,供醫療工作者使用。

面對新冠疫情,為滿足口罩、防護服等防疫用品日益增長的需求,歐盟開啟綠色通道,無需CE標識,可進入歐盟,供醫療工作者使用。允許部分防疫物資(如一類滅菌的醫用口罩)在符合安全有效的情況下,即使尚未獲得CE認證,也可以在歐盟市場上市銷售。

3月17日,美國FDA對新冠病毒檢測產品也開通了類似的上市綠色通道,允許檢測試劑盒在還未獲EUA授權之前,可以先進入臨床市場。目前,包括華大基因在內的多家國內企業均已啟動產品在美國臨床市場的商業銷售。

2020年3月13日,歐盟會員會在歐洲官方雜志( Official Journal of the EuropeanUnion)發布了疫情期間針對醫療器械和個人防護用品 (PPE)的符合性評價和市場監督程序的建議。

醫療器械方面:

◆如果市場監督機構確定產品符合醫療器械的基本安全和性能要求,即使其符合性評價還未完成,市場監督機構可以允許其在一定的時間內進行銷售,同時該產品必須繼續完成其符合性評價過程。

◆成員國主管當局也可在疫情期間評估和組織采購沒有CE標記的醫療器械,該產品僅可提供給醫療工作者使用,不能在市場上流通銷售。同時市場抽查將會重點抽查防疫相關醫療器械,以防止不合格產品導致嚴重風險。

個人防護用品(PPE)方面:

◆涉及的產品包括拋棄式和可重復使用的口罩、可重復使用的工作服、手套和眼罩等(主要是預防病毒和有害物質的產品)。需要具有PPE法規授權資格的公告機構進行符合性評價。

◆應急審批產品如果不采用PPE法規協調標準作為產品技術要求而采用其它技術要求,比如WHO的推薦要求,須確保采用的技術要求與PPE法規基本健康與安全要求同等防護水平。公告機構對這類采用其它技術要求的PPE產品進行發證時,需要立即通知主管當局和其它PPE法規的公告機構。

◆如果市場監督機構確定產品符合PPE法規的基本健康和安全要求,即使其符合性評價還未完成,市場監督機構可以允許其在一定的時間內進行銷售,同時該產品必須繼續完成其符合性評價過程。

◆成員國主管當局也可在疫情期間評估和組織采購沒有CE標記的PPE產品,該產品僅可提供給醫療工作者使用,不能在市場上流通銷售。同時市場抽查將會重點抽查防疫相關PPE產品,以防止不合格產品導致嚴重風險。

也就是說,只要處于正在進行符合性評估的過程中,就可以在沒有CE標志的情況下先行進入歐盟市場。由市場監督部門進行抽查,發現問題再進行處罰。

重點如下!!!

◆成員國可采購安全有效,但沒有CE標記的醫療產品;

◆緊急物資專供醫療人員使用,不可在市場上流通;

◆僅疫情期間有效。

關于CE標識

CE標簽就像一把巨傘,底下是規定各類產品安全標準、細分到不同材料和生產模式等的各種歐盟指令。自1985年成立以來,它就成為了高質量、高標準和嚴格執法的標志,缺少這一標志的商品將不予獲準進入歐盟市場。

如今CE標識已經成為了全球認可的質量標志,CE標志可以證明該批在歐盟制作或進口至歐盟成員國的產品符合質量標準,滿足保護消費者健康、供應鏈安全和環境可持續發展的要求。

在歐盟,口罩屬于PPE個人防護用品,“危及健康的物質和混合物”。2019年起,歐盟新法規PPE Regulation (EU) 2016/425強制執行,所有出口歐盟的口罩必須在新法規的要求下獲得CE認證證書。CE認證證書的有效期是5年左右,一般費用是10000-15000元人民幣。

歐盟對于口罩歐洲統一,CE認證的標準包括BSEN140、BSEN14387、BSEN143、BSEN149、BSEN136,其中BSEN149使用多,為可防護微粒的過濾式半口罩,根據測試的粒子穿透率分為P1(FFP1),P2(FFP2),P3(FFP3)三個等級,FFP1低過濾效果≥80%,FFP2低過濾效果≥94%,FFP3低過濾效果≥97%。

FFP2口罩與上文提到的醫用防護口罩、KN95口罩、N95口罩過濾效率十分接近。醫療口罩必須遵循BSEN14683標準,可以分為三個等級:低標準Type、然后是Type和TypeR。上一個版本是BSEN146832014,已被新版BSEN146832019所取代。EN 14683:2019年版主要的變化之一是壓力差,Type、Type、TypeR壓力差分別由2014年版的29.4、29.4、49.0Pa/cm,上升至40、40、60Pa/cm。

CE認證是歐盟實行的強制性產品安全認證制度,目的是為了保障歐盟國家人民的生命財產安全。

新手小白可以問自己的發證機構兩個問題:

01、貴司是否為NB機構? 機構號是否可以查詢?

02、出具的CE證書在官網可查嗎?

NB機構可以理解為被歐盟授權或認可的機構。如果CE證書是NB機構發證的,在歐盟就具有一定的效應,清關的風險才會相對較小。

正常情況下,根據歐盟法規,所有出口歐盟的產品都需要獲得CE認證,加貼CE標識才能進入歐洲市場。CE認證的審核和發證,歐盟公布了一系列由歐盟統一監管和認證資質授權的機構,并授予每家機構一個唯一的四位數編碼即公告號,CE證書的申請和頒發就由對應法規和指令授權的公告號機構頒發。

在歐盟官方網站-歐盟公告機構查詢官網,廠家可以查詢到目前從0001-2786 兩千多家歐盟公告號機構詳細信息,每家機構對應的指令和法規授權以及發證機構信息都可在該網站查詢到。

附:CE認證查驗:

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

附:FDA查驗(出口美國需要FDA和NIOSH):

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

近期,大家都在對口罩等醫療物資的歐盟標準犯愁,都是一知半解的狀態,今天Mike將歐盟通告原文貼出,大家可以自己好好研究一下每種標準的具體陳述;昨天給了鏈接后,很多人說打不開網頁,其實應該是你們的局域網問題,不過沒關系,我給你們貼出來:

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:

01

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. In addition, the global supply chain of such products has also sustained significant disruptions, which have induced repercussions on the EU market as well.

02

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.

03

Economic operators active across the EU are working relentlessly to increase their respective manufacturing and distribution capacity. In order to mitigate the effects of the various disruptive factors, the economic operators are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base. These efforts by the industrial stakeholders would not be able to produce their full effects if the increased supply cannot feed into the market without any undue delays.

04

The requirements for the design, manufacturing and placing on the market of personal protective equipment are laid down by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (1).

05

The requirements for the design, manufacturing and placing on the market of medical devices are laid down by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2). That Directive is repealed by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (3), with effect from 26 May 2020.

06

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.

07

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.

08

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.

09

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.

11

PPE intended to protect against harmful biological agents, such as viruses are listed in Annex I of Regulation (EU) 2016/425 as category III, which includes exclusively the risks that may cause ‘very serious consequences such as death or irreversible damage to health’.

12

Relevant medical devices as non-invasive devices are in Class I, unless specific rules apply.

13

In accordance with Article 8 of Regulation (EU) 2016/425, in order to place PPE products on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, affix the CE marking.

14

In accordance with Article 11 of Directive 93/42/EEC and with Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, in order to place medical devices on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential requirements or general safety and performance requirements has been demonstrated by the appropriate procedure, affix the CE marking. Derogations from conformity assessment procedures may be authorised by Member States, on duly justified request, for the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices the use of which is in the interest of protection of health.

15

Regulation (EU) 2016/425 is technologically neutral and does not lay down any specific mandatory technical solutions for the design of PPE products. Instead, Annex II to Regulation (EU) 2016/425 sets the essential health and safety requirements, which PPE should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.

16

Directive 93/42/EEC and Regulation (EU) 2017/745 are technologically neutral and do not lay down any specific mandatory technical solutions for the design of medical devices. Instead, Annex I to Directive 93/42/EEC sets the essential requirements, and Annex I to Regulation (EU) 2017/745 sets the general safety and performance requirements, which medical devices should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.

17

Article 14 of Regulation (EU) 2016/425 offers 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 PPE is presumed to be in conformity with the essential health and safety 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 PPE complies with the applicable essential health and safety requirements.

18

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.

19

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.

20

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.

21

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.

22

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.

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,

HAS ADOPTED THIS RECOMMENDATION:

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

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.

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.

MARKET SURVEILLANCE PROCEDURES

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).

Done at Brussels, 13 March 2020.

For the Commission

Thierry BRETON

Member of the Commission

原文查看(實在打不開的,建議換瀏覽器或電腦試試): http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020H0403&from=EN

COVID-19威脅范圍內的合格評定和市場監督程序

(翻譯版供參考,具體請以英文原版為準)

歐洲委員會,考慮到《歐洲聯盟運作條約》,特別是其第292條,鑒于:

1、在當前的COVID-19全球爆發以及病毒在歐盟各個地區的快速傳播的背景下,對個人防護設備(以下稱“ PPE”)的需求,例如口罩,手套,防護工作服或眼鏡防護以及用于外科口罩,探查手套和某些禮服等醫療設備的數量呈指數增長。特別是,由于通過現有渠道以及通過新渠道的需求呈指數增長,某些類型的PPE(例如一次性口罩)的供應鏈承受著巨大的壓力。此外,此類產品的全球供應鏈也遭受了嚴重破壞,這也引起了歐盟市場的反響。

2、牢記歐盟公民的健康和安全是重中之重,因此,確保向最需要的人迅速提供最適當的個人防護設備和醫療設備,以確保提供足夠的保護,這一點至關重要。

3、活躍于整個歐盟的經濟運營商正在不懈努力,以提高各自的制造和分銷能力。為了減輕各種破壞性因素的影響,經濟運營商正在通過啟動新的生產線和/或使其供應商基礎多樣化來重新設計其供應鏈。如果供應增加而沒有任何不適當的延誤,則工業利益相關者的這些努力將無法發揮全部作用。

4、有關個人防護設備的設計,制造和投放市場的要求,由歐洲議會和理事會于2016年3月9日頒布的第(EU)2016/425號條例(關于個人防護設備)以及廢除理事會第89/686號指令規定/ EEC (1)。

5、1993年6月14日關于醫療器械的理事會指令93/42 / EEC對醫療器械的設計,制造和投放市場提出了要求 (2)。歐洲議會和2017年4月5日關于醫療器械的理事會(EU)2017/745條例,該指令2001/83 / EC,條例(EC)178/2002和條例(EC)的修訂已廢除該指令1223/2009和廢除理事會指令90/385 / EEC和93/42 / EEC  (3),自2020年5月26日起生效。

6、一次性和可重復使用的口罩,可防止顆粒物危害,一次性和可重復使用的工作服,手套和眼鏡防護,用于預防和防止有害生物制劑(如病毒)屬于本法規范圍內的產品(歐盟)2016/425。

7、外科口罩,檢查手套和某些長袍類型的產品屬于93/42 / EEC指令和2017/745法規(EU)的范圍。

8、在發生COVID-19威脅的情況下,此類PPE和醫療設備對于參與遏制病毒并避免其進一步傳播的醫護人員,急救人員和其他人員至關重要。

9、(EU)2016/425法規充分協調了PPE的設計,制造和投放市場的規則,并根據PPE的類別(取決于其所面臨的風險)對PPE提出了一些基本的健康和安全要求旨在保護用戶。因此,根據法規(EU)2016/425制造的PPE物品可以在整個內部市場自由流通,成員國不得對此類產品的制造和投放市場引入額外的和不同的要求。

10、93/42 / EEC指令和(EU)2017/745法規充分協調了醫療器械聯盟市場的設計,制造和銷售規則,并根據以下內容建立了一些基本要求以及一般安全和性能要求根據受器械預期用途支配的特定規則對醫療器械進行分類。因此,根據理事會指令93/42 / EEC和法規(EU)2017/745制造的設備可以在整個內部市場自由流通,成員國不得對此類設備的制造和投放市場引入額外的和不同的要求產品。

11、PPE旨在防止有害生物制劑,如病毒在法規附件I(EU)四百二十五分之二千零十六為III類,其中包括完全可能導致的風險上市“非常嚴重的后果,如死亡或不可逆的損害健康 ” 。

12、除非適用特定規則,否則與非侵入性設備相關的醫療設備屬于I類。

13、根據(EU)2016/425號法規第8條,為了將PPE產品投放市場,制造商應執行適用的合格評定程序,并在符合條件的情況下證明符合適用的基本健康和安全要求按照適當的程序,貼上CE標志。

14、根據指令93/42 / EEC的第11條和(EU)2017/745法規的第52條,一旦后者適用,為了將醫療設備投放市場,制造商應執行適用的合格評定程序并且,如果通過適當的程序證明符合適用的基本要求或一般安全和性能要求,請貼上CE標志。會員國可應正當理由要求批準從合格評定程序中減損,以便在有關會員國領土內投放市場并在使用中保護受保護的單個設備健康。

15、法規(EU)2016/425在技術上是中立的,沒有為PPE產品的設計規定任何特定的強制性技術解決方案。相反,法規(EU)2016/425的附件II規定了基本的健康和安全要求,PPE應該滿足這些基本要求,以便能夠投放市場并在整個歐盟市場上自由流通。

16、93/42 / EEC指令和法規(EU)2017/745在技術上是中立的,沒有為醫療設備的設計規定任何特定的強制性技術解決方案。相反,指令93/42 / EEC的附件I設置了基本要求,法規(EU)2017/745的附件I設置了一般安全性和性能要求,醫療設備應滿足這些要求才能將其放置在市場,并在整個歐盟市場上自由流通。

17、(EU)2016/425號法規第14條為制造商提供了依賴特定技術解決方案的可能性,這些解決方案在統一標準或其部分中進行了詳細說明,其參考文獻已在《歐盟官方雜志》上發表。根據本條,如果制造商選擇采用這樣的技術解決方案,則假定個人防護設備符合上述統一標準或其部分所涵蓋的基本健康和安全要求。但是,并非必須遵守協調標準。制造商可以自由選擇其他技術解決方案,前提是保留的特定解決方案可確保PPE符合適用的基本健康和安全要求。

18、指令93/42 / EEC的第5條和法規(EU)2017/745的第8條為制造商提供了依賴特定技術解決方案的可能性,這些解決方案在統一標準或其部分中作了詳細說明,其參考文獻已在歐盟官方雜志。根據本條,如果制造商選擇采用這種技術解決方案,則假定醫療器械符合上述協調標準或其部分所涵蓋的要求。但是,并非必須遵守協調標準。制造商可以自由選擇其他技術解決方案,前提是保留的特定解決方案可確保醫療設備符合適用的基本健康和安全要求。

19、(EU)2016/425號法規第19條規定了具體的合格評定程序,該程序適用于不同類別的PPE。根據本條,第三類個人防護裝備的項目,例如旨在防止有害生物制劑的項目,應進行合格評定程序的特定組合,分別在同一法規的附件V,VII和VIII中進行描述。可能使用的每種不同的合格評定程序都需要第三方合格評定機構的強制參與。

20、93/42 / EEC指令的第11條和法規(EU)2017/745的第52條一旦適用,就制定適用于不同類別醫療設備的特定合格評定程序。根據這些條款,屬于第一類的醫療設備(定制或研究用設備除外)應接受EC合格聲明的合格評定程序,而無需第三方合格評定機構的參與。

21、公告機構是成員國指定的合格評定機構,并有權執行法規(EU)2016/425中的第三方合格評定任務。根據第(EU)2016/425號法規第26條第4款和附件V第7點(f)的規定,指定機構必須評估PPE產品是否符合適用的基本健康和安全要求。認證機構不僅需要在制造商采用統一標準的地方進行評估,還需要在制造商遵循其他技術解決方案的情況下進行評估。交付合格評定證書時,指定機構必須通知其通知當局,也可能需要將其簽發的證書通知其他指定機構,

22、因此,公告機構應評估根據其他技術解決方案生產的產品(例如,世衛組織關于適當選擇個人防護裝備的建議中所包含的產品)是否也符合適用的基本健康和安全要求。考慮到確保個人防護裝備供應鏈中所有利益相關者之間有效信息交換的重要性,公告機構得出結論認為,遵循另一項特定標準或技術解決方案的個人防護裝備符合適用于其的基本健康和安全要求,這些信息將有助于快速評估根據同一特定標準或技術解決方案生產的其他產品。為此,

23、此外,根據法規(EU)2016/425中的相關市場監督程序,尤其是其中的第38(1)和(2)條,如果市場監督機構遇到非CE標志的PPE產品,則需要對其進行評估它。市場評估機構在評估過程中發現個人防護設備不符合本規章的要求時,應要求經濟經營者采取糾正措施以使個人防護設備符合要求或召回或撤回它,與風險的性質相稱。他們還應將評估結果以及他們要求經濟經營者采取的行動告知委員會和其他成員國。

24、因此,為了解決在COVID-19爆發時(非CE標志的PPE打算進入歐盟市場)所必需的PPE短缺的問題,相關的市場監督機構應對產品進行評估,如果發現這些產品屬于符合相關法規所規定的基本健康與安全要求的人員,應采取措施,在有限的時間內或在與指定機構進行合格評定程序的同時,將此類PPE投放到歐盟市場。為了確保可以在其他會員國提供此類產品,并考慮到確保有效交換信息以及對對公民健康和安全的所有威脅作出協調反應的重要性,

25、考慮到在COVID-19爆發中使用的某些類型的PPE或醫療設備也可能用于其他目的,有必要使會員國采取一切適當措施,以確保不攜帶PPE或醫療設備的醫療設備。根據本建議書第8段可以在歐盟市場上投放的CE標記僅提供給醫護人員,

通過了此建議:

1.為了確保在COVID-19爆發中提供個人防護設備和醫療設備以提供適當的保護,委員會邀請整個供應鏈中的所有經濟運營商以及指定機構和市場監督機構在其部署中采取所有措施處置以支持旨在確保整個歐盟市場的個人防護設備和醫療設備的供應與不斷增長的需求相匹配的工作。但是,此類措施不應對整體健康和安全水平產生不利影響,所有相關利益相關方應確保投放到歐盟市場的任何個人防護設備或醫療設備繼續為用戶提供足夠的保護水平' 健康和安全。

合格評定程序

2、根據(EU)2016/425號條例的指定機構,應優先考慮并迅速進行PPE經濟運營商在保護COVID-19時應保護的PPE經濟運營商所有新提交的要求中的合格評定活動。

3、對于遵循非統一標準的技術解決方案生產的PPE產品,只要這些技術解決方案確保足夠的保護水平,WHO關于適當選擇PPE的建議可以用作此類技術解決方案的潛在參考來源。符合法規(EU)2016/425規定的適用基本健康與安全要求。

4、向遵循統一標準以外的其他技術解決方案生產的PPE產品頒發證書的認證機構,應立即將其頒發的證書和遵循的具體技術解決方案通知相關的通報機構以及根據(EU)2016/425條的其他認證機構。公告機構應通過根據法規(EU)2016/425第36條成立的公告機構小組的協調來交換此類信息。

5,就醫療器械而言,根據指令93/42 / EEC第11(13)條和法規(EU)2017/745的第59條,還應考慮成員國授權從合格評定程序中減損的可能性。后者在不需要指定機構介入的情況下也適用。

市場監督程序

6、成員國的相關市場監督機構應優先關注不合規的個人防護設備或醫療設備,這些設備會對其預期用戶的健康和安全造成嚴重風險。

7、市場監督機構發現PPE或醫療設備可確保根據(EU)2016/425法規或93/42 / EEC指令或2017(EU)法規的基本要求確保足夠的健康和安全水平/ 745,即使尚未按照協調規則完全完成包括CE標志在內的合格評定程序,它們仍可以授權在限定的時間內在歐盟市場上提供這些產品程序正在執行中。

8、不帶CE標志的PPE或醫療設備也可以進行評估,并由相關成員國當局組織購買的一部分,前提是要確保此類產品僅在當前健康危機期間可供醫護人員使用,并確保它們沒有進入常規分銷渠道,并可供其他用戶使用。

9、市場監督機構應立即將其授予特定PPE或醫療設備的任何臨時安排告知委員會和其他成員國。對于個人防護設備,應通過用于市場監視的信息和通信系統(ICSMS)來完成。

附:歐盟成員國名單(27國):

奧地利、比利時、保加利亞、塞浦路斯、捷克、克羅地亞、丹麥、愛沙尼亞、芬蘭、法國、德國、希臘、匈牙利、愛爾蘭、意大利、拉脫維亞、羅馬尼亞、立陶宛、盧森堡、馬耳他、荷蘭、波蘭、葡萄牙、斯洛伐克、斯洛文尼亞、西班牙、瑞典。

(來源:Mike外貿說
以上內容屬作者個人觀點,不代表雨果網立場!本文經原作者授權轉載,轉載需經原作者授權同意。

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