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十年专注CE认证MD、CPR(CPD)、PPE、ROHS、LVD、EMC...

十年专注CE认证MD、CPR(CPD)、PPE、ROHS、LVD、EMC...

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出口企业制造商及进口商的义务是什么?

Obligations of manufacturers

1.   When placing their electrical equipment on the market, manufacturers shall ensure that it has been designed and manufactured in accordance with the safety objectives referred to in Article 3 and set out in Annex I.

2.   Manufacturers shall draw up the technical documentation referred to in Annex III and carry out the conformity assessment procedure referred to in Annex III or have it carried out.

Where compliance of electrical equipment with the safety objectives referred to in Article 3 and set out in Annex I has been demonstrated by the conformity assessment procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3.   Manufacturers shall keep the technical documentation referred to in Annex III and the EU declaration of conformity for 10 years after the electrical equipment has been placed on the market.

4.   Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in product design or characteristics and changes in the harmonised standards referred to in Article 12, the international or national standards referred to in Articles 13 and 14, or in other technical specifications by reference to which conformity of electrical equipment is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by electrical equipment, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of electrical equipment made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming electrical equipment and electrical equipment recalls, and shall keep distributors informed of any such monitoring.

5.   Manufacturers shall ensure that electrical equipment which they have placed on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the electrical equipment does not allow it, that the required information is provided on its packaging or in a document accompanying the electrical equipment.

6.   Manufacturers shall indicate on the electrical equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the electrical equipment. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

7.   Manufacturers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.

8.   Manufacturers who consider or have reason to believe that electrical equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that electrical equipment into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the electrical equipment presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the electrical equipment available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

9.   Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the electrical equipment with this Directive, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by electrical equipment which they have placed on the market.

 

制造商的义务

1.在将电气设备投放市场时,制造商应确保其设计和制造符合第3条所述的安全目标,并在附件I中列出。

2.制造商应起草附件三所述的技术文件,并执行附件三所述的合格评定程序或进行。

如果第1项中提到的合格评定程序已证明电气设备符合第3条所述和附件I中所述的安全目标,则制造商应制定欧盟符合性声明并加贴CE标志。

3.电气设备投放市场后,制造商应保留附件III中提及的技术文件和欧盟符合性声明10年。

4.制造商应确保批量生产的程序符合本指令。产品设计或特性的变化以及第12条所述的协调标准的变化,第13条和第14条所述的国际或国家标准,或其他技术规范中提及的电气设备的符合性均应予以充分考虑到了。对于电气设备所带来的风险,如果认为合适,制造商应为保护消费者的健康和安全,对市场上可用的电气设备进行抽样检测,调查,并在必要时保留登记表。 不符合要求的电气设备和电气设备召回,并应通知经销商注意此类产品监控。

5.制造商应确保其在市场上销售的电气设备具有允许其识别的类型,批次或序列号或其他元件,或者,如果电气设备的尺寸或性质不允许,则提供所需信息。在其包装上或随电气设备提供的文件中提供。

6.制造商应在电气设备上注明其名称,注册商标名称或注册商标以及可以联系的邮政地址,如果不可能,则在其包装或电气设备随附的文件中注明。地址应表明可以联系制造商的单个点。联系方式应采用最终用户和市场监管机构易于理解的语言。

7.制造商应确保电气设备附有指令和安全信息,其语言应由消费者和其他最终用户容易理解,由有关成员国确定。此类说明和安全信息以及任何标签应清晰,易懂且易于理解。

8.认为或有理由相信他们在市场上销售的电气设备不符合本指令的制造商应立即采取必要的纠正措施,使电气设备符合要求,撤回或召回,如果适当。此外,在电气设备存在风险的情况下,制造商应立即通知其在市场上制造电气设备的成员国的主管国家主管部门,并详细说明不遵守情况和采取的任何纠正措施。

9.制造商应进一步根据国家主管当局的合理要求,以易于理解的语言向其提供证明电气设备符合本指令所必需的纸质或电子形式的所有信息和文件。由那个权威。应要求,他们应与该当局合作,采取任何行动消除他们投放市场的电气设备所带来的风险。

 

Obligations of importers

1.   Importers shall place only compliant electrical equipment on the market.

2.   Before placing electrical equipment on the market importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the electrical equipment bears the CE marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).

Where an importer considers or has reason to believe that electrical equipment is not in conformity with the safety objectives referred to in Article 3 and set out in Annex I, he shall not place the electrical equipment on the market until it has been brought into conformity. Furthermore, where the electrical equipment presents a risk, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3.   Importers shall indicate on the electrical equipment their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the electrical equipment. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

4.   Importers shall ensure that the electrical equipment is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

5.   Importers shall ensure that, while electrical equipment is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the safety objectives referred to in Article 3 and set out in Annex I.

6.   When deemed appropriate with regard to the risks presented by electrical equipment, importers shall, to protect the health and safety of consumers, carry out sample testing of electrical equipment made available on the market, investigate and, if necessary, keep a register of complaints, of non-conforming electrical equipment and electrical equipment recalls, and shall keep distributors informed of any such monitoring.

7.   Importers who consider or have reason to believe that electrical equipment which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that electrical equipment into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the electrical equipment presents a risk, importers shall immediately inform the competent national authorities of the Member States in which they made the electrical equipment available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

8.   Importers shall, for 10 years after the electrical equipment has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

9.   Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of electrical equipment in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by electrical equipment which they have placed on the market.

 

进口商的义务

1.进口商应仅在市场上放置符合要求的电气设备。

2.在将电气设备投放市场之前,进口商应确保制造商已进行适当的合格评定程序。他们应确保制造商已制定技术文件,电气设备带有CE标志并附有所需文件,并且制造商已遵守第6(5)和(6)条规定的要求。

如果进口商认为或有理由认为电气设备不符合第3条所述和附件I所列的安全目标,则在将电气设备投入使用之前,不得将电气设备投放市场。此外,如果电气设备存在风险,进口商应通知制造商和市场监督机构。

3.进口商应在电气设备上注明其名称,注册商标名称或注册商标以及可以联系的邮政地址,如果不可能,则在其包装或电气设备随附的文件中注明。联系方式应采用最终用户和市场监管机构易于理解的语言。

4.进口商应确保电气设备附有指令和安全信息,其语言应由消费者和其他最终用户容易理解,由有关成员国确定。

5.进口商应确保在电气设备负责的同时,其储存或运输条件不会危及其遵守第3条所述和附件I所列安全目标的情况。

6.如果认为电气设备所带来的风险是适当的,进口商应为保护消费者的健康和安全,对市场上提供的电气设备进行抽样检测,并在必要时保存一份登记册。投诉,不合格电气设备和电气设备召回,并应通知经销商关注此类监控。

7.认为或有理由相信他们在市场上销售的电气设备不符合本指令的进口商应立即采取必要的纠正措施,使电气设备符合要求,撤回或召回,如果适当。此外,如果电气设备存在风险,进口商应立即通知其在市场上提供电气设备的成员国的主管国家主管部门,并详细说明不遵守情况和采取的任何纠正措施。

8.进口商应在电气设备投放市场10年后,保留一份欧盟符合性声明的副本供市场监督机构使用,并确保向当局提供技术文件,根据要求。

9.进口商应进一步根据国家主管当局的合理要求,向其提供纸质或电子形式的所有信息和文件,以证明电气设备符合该当局易于理解的语言。应要求,他们应与该当局合作,采取任何行动消除他们投放市场的电气设备所带来的风险。

EU DECLARATION OF CONFORMITY

EU符合性声明样式

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创建时间:2019-05-07 10:50

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