Technical documentation and EU declaration of conformity技术文档和欧盟符合性声明
The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.
技术文档提供了有关产品设计、制造和操作的信息，必须包含所有必要的细节以证明产品符合适用的要求。
If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:
如果您是制造商，在将产品投放市场时必须遵循某些规则；您必须：
-
prepare the technical documentation before placing a product on the market
在将产品投放市场之前准备好技术文档 -
ensure the technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market
确保在产品投放市场时，技术文档可以随时提供给市场监管机构（如果他们要求查看） -
keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise)
自产品投放市场之日起，保存技术文档 10 年（除非另有明确规定）
The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.
技术文档是证明产品符合基本要求的必要条件，因此可以证明和支持欧盟符合性声明。您需要这些文档才能在产品上贴上 CE 标志。
How to draw up the technical documentation?
如何编制技术文档？
The technical documentation should include at least:
技术文档至少应包括：
-
your name and address, or those of any authorised representatives
您的姓名和地址，或任何授权代表的姓名和地址 -
a brief description of the product
产品的简要描述 -
identification of the product, for example, the product's serial number
产品的识别信息，例如产品的序列号 -
the name(s) and address(es) of the facilities involved in the design and manufacture of the product
参与产品设计和制造的设施的名称和地址 -
the name and address of any notified body involved in assessing the conformity of the product
任何参与评估产品合规性的公告机构的名称和地址 -
a statement of the conformity assessment procedure that has been followed
已遵循的合格评定程序声明 -
the EU declaration of conformity
欧盟合格声明 -
label and instructions of use
标签和使用说明 -
a statement of relevant regulations to which the product complies
产品符合的相关法规声明 -
identification of technical standards with which compliance is claimed
符合性声明所依据的技术标准识别 -
list of parts 部件清单 -
test results 测试结果
As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained.
作为制造商，您应能够证明文件的各个部分存放和维护的位置和方式。
You can usually choose in which language you want to prepare the technical documentation. However, the market surveillance authorities may ask you to translate the technical documentation depending on the EU country where the product has been placed on the market. If requested, you can also provide it in electronic format.
您通常可以选择用哪种语言准备技术文档。然而，市场监管机构可能会根据产品投放市场的欧盟国家要求您翻译技术文档。如果有要求，您也可以以电子格式提供。
Risk assessment 风险评估
As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirements. This analysis must be included in the technical documentation. In addition, you will need to explain the ways in which you have addressed the risks identified to ensure that your product complies with the applicable requirements, for example, by applying harmonised standards.
作为制造商，您有责任识别产品可能带来的所有风险，并确定适用的基本要求。此分析必须包含在技术文档中。此外，您需要解释您如何解决所识别的风险，以确保您的产品符合适用要求，例如通过应用协调标准。
EU declaration of conformity
欧盟符合性声明
An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.
欧盟符合性声明（DoC）是一个强制性文件，作为制造商的您或您的授权代表需要签署，以声明您的产品符合欧盟要求。通过签署 DoC，您对产品符合适用的欧盟法律承担全部责任。
How to draw up a declaration of conformity
如何起草符合性声明
As a manufacturer, it is your responsibility to draw up the EU declaration of conformity(DoC). It should contain the following information:
作为制造商，起草欧盟符合性声明（DoC）是您的责任。它应包含以下信息：
-
your name and full business address or that of your authorised representative
您的姓名和完整的营业地址或您授权代表的地址 -
the product's serial number, model or type identification
产品的序列号、型号或类型标识 -
a statement, stating you take full responsibility
声明，表明您承担全部责任 -
means of identification of product allowing traceability – this can include an image
允许产品追溯的识别方式——这可以包括一张图片 -
the details of the notified body which carried out the conformity assessment procedure (if applicable)
进行合格评定程序的公告机构的详细信息（如适用） -
the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
产品符合的相关法律法规，以及用于证明合规的任何协调标准或其他方法 -
your name and signature
您的姓名和签名 -
the date the declaration was issued
声明签发的日期 -
supplementary information (if applicable)
补充信息（如适用）
For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market.
对于进口产品，进口商必须确保产品附有符合性声明，并在产品投放市场后保存一份副本 10 年。
You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.
您必须将欧盟符合性声明翻译为您产品销售所在欧盟国家所要求的语言。
来源https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm