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【求助】declaration of conformity属于
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这个帖子发布于5年零26天前，其中的信息可能已发生改变或有所发展。
请问ceclaration of conformity属于16号令附件6中的第9项生产企业出具的产品质量保证书还是属于第4项境外政府医疗器械主观部门批准或者认可的该产品作为医疗器械进入该国（地区）市场的证明文件？还是属于其他的什么呢？觉得这些certificate为什么看上去都差别不是很大？很困惑
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我觉得应该是前者。
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hehewang 我觉得应该是前者。谢谢！
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By means of a CE Declaration of Conformity (certificate de conformite), the manufacturer must demonstrate that his product complies with the essential health and safety requirements of the relevant CE directives. Prior to this, the product may not be sold on the European internal market. The Declaration of Conformity is: ?procedure in which the manufacturer or his authorized representative established in the European Union declares that the product placed on the market complies with all the relevant safety requirements of the appropriated directive (s). ?a form that is to be supplied with every product and must be drawn up in the user's language. The CE Mark is the external proof of the CE Conformity Declaration.
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，“EC declaration of Conformity”是欧盟指令要求的“EC自我宣告”，就是厂家宣告自己的产品符合相关的CE指令。如果你已经有了测试报告，就自己出一个这个宣告就行了。按照CE法规（指令），自我宣告是必须的，代表厂家对法规的负责。这个宣告的内容参照你拿到的“CE证书”。
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EC DECLARATION OF CONFORMITY1. No xxxxxx (unique identification of the product):2. Name and address of the manufacturer and/or his authorised representative:3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):5. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:7. Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….8. Additional information:Signed for and on behalf of: ………………………….(place and date of issue)(name, function) (signature)
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客户出具了EC declaration of conformity,是不是表明这个产品是得到CE认证的,
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EC&declaration&of&conformity,EC是一种认证模式（详见图片）,即欧共体吧.出具了“欧共体符合标准声明”.有些产品不一定要CE认证,只要提供根据某种产品标准,出具符合该标准的声明就可以了.与CE有区别.
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CE Declaration of Conformity 是什么
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欧共体符合性声明.By means of a CE Declaration of Conformity (certificate de conformite),the manufacturer must demonstrate that his product complies with the essential health and safety requirements of the relevant CE directives.Prior to this,the product may not be sold on the European internal market.The Declaration of Conformity is:•procedure in which the manufacturer or his authorized representative established in the European Union declares that the product placed on the market complies with all the relevant safety requirements of the appropriated directive (s).•a form that is to be supplied with every product and must be drawn up in the user's language.The CE Mark is the external proof of the CE Conformity Declaration.
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