Since its adoption in 1985, CE marking has been a mainstay of European trade and commerce. For manufacturers, applying a CE mark has a number of advantages, including unrestricted trade within the European Union, enhanced product safety and reduced environmental impact. However, navigating the complex web of risk analysis, harmonized standards and technical requirements can be a daunting task. Our experts help you understand and apply the directives that pertain to your product, and successfully complete the certification process.

Given the extensive reach of CE marking, it isn’t surprising that most products require compliance to at least one of more than 25 major directives that govern product certification. From toys and textiles to electronics and power tools, almost all products that consumers interact with on a daily basis require a CE mark to be sold in the EU. Despite the ubiquity of this legislation, however, many companies struggle with understanding what, exactly, CE marking is.

什么是CE标志2018-02-07
CE marking services

Frequently Asked Questions (FAQs)

What is CE Marking? What are CE Marking directives? What are technical files and Declarations of Conformity (DoC)? How do I complete CE Marking?

What is CE Marking?

CE标志是一个强制性的合格标签lows for the free movement of goods across the European Union. Because this legislation supersedes the laws of individual countries, products that carry a CE mark are authorized for sale in all EU Member States without additional technical or regulatory requirements.

What are CE Marking Directives?

CE标记过程由指令的使用驱动。指令是欧洲委员会起草和批准的一项立法,必须纳入每个成员国的法律制度。用于为特定类别类别提供最低要求,大多数指令都是故意含糊的测试和遵守的具体要求,并专注于“基本要求”。从属统一标准包含产品必须遵守的技术细节,从而允许最先进的情况经常在未能更新指令的法律文本的情况下定期更改。

Determining which directive(s) applies to your product can be a challenge, considering that most directives are written in a legal form rather than for laypersons and is often buried in the directive itself. An important step in compliance with a directive is performing a risk assessment. This is the process where a manufacturer identifies all the hazards covered by the directive and then mitigates these hazards through a test assessment (typically using a harmonized standard(s)) or through a modification to the design, labelling or instructions.

鉴于确定指令和统一标准的复杂任务,加上措辞解释,元素通过其提供指导Early Stage Qualification (ESQ®)team.

什么是通知的身体?

A Notified Body (NB) is an organization that has been approved by the EU Commission to provide type-examination to manufacturers seeking a CE mark. Working with a Notified Body can greatly mitigate the risks of choosing the wrong directive, critical defect or safety failure, or being found non-compliant in the administrative requirements of CE marking.

For directives that are particularly safety-critical, review by a Notified Body is a mandatory step in declaring compliance. In these cases, we can provide the necessary testing to prove product safety and fitness, and assist in creating technical files. Element is a Notified Body for a number of CE marking directives, including The无线电设备指令,Machinery Directive,EMC Directive, and爆炸性的氛围(ATEX) Directive.

联系我们有关通知正文服务的完整列表。

What are Technical Files and Declarations of Conformity (DoC)?

为了CE标记您的产品,您需要编译一份文档列表,证明它符合绩效,安全和功能的某些标准。被称为技术文件,这应该包括设计图纸,图表,技术理由,测试报告,使用说明,支持通知机构的文件(如果需要),以及证明产品符合该指令的任何其他证据。

Once this is compiled, a Declaration of Conformity (DoC) needs to be completed for the product being marked. During this step, you will collate the information in your technical file and any other pertinent product information, and will sign a Declaration of Conformity, declaring that the product meets all the requirements of the applicable CE Marking directives. This is a legally binding document that unequivocally states that your product is safe for use, and meets all of the required directives and harmonized standards, where applicable.

Once this is completed, you are ready for the last step in the process – CE marking certification.

How Do I Complete CE Marking?

总的来说,CE标记是一个自我声明过程,这意味着您将把标记应用于您的产品,并在没有监管机构的任何其他投入(对于某些产品,通知机构需要发出类型的考试证书确认他们已对该指令评估了技术档案。一旦标记贴,您的产品可以在欧盟和欧洲经济区(EEA)的任何地方出售,而无需从个别成员国的其他认证。乐动体育软件最新版

Any product can be audited at any time by a European Market Surveillance authority, so it’s important to keep the technical file for your product in its entirety, and to perform regular testing of your products to confirm ongoing compliance to the technical requirements. CE marking requires that every product sold conforms to its requirements, so batch testing and ongoing quality assurance are necessary for maintaining compliance.

CE marking can be a difficult and confusing process to complete. Element is here to support your journey to certification through every step, from design guidance and testing to compiling and storing technical files and completing routine maintenance testing. In addition to our testing services, our team ofEarly Stage Qualification (ESQ®)专家提供合规策略和测试计划的投入,可以帮助global approvalswhen you’re ready to take your product to other markets around the world. No matter where you are in the CE marking process, we can help make your project a success.

有关CE标记的更多信息以及如何认证您的产品,或要求引用,请立即联系专家。

CE标记过程
CE标记服务

CE标记过程

对于大多数产品,CE标记遵循8步的认证。乐动体育软件最新版

Although it may seem like a complicated process, CE marking follows a relatively simple set of steps. Our experts can assist in every stage of this journey, from determining the appropriate requirements to maintenance testing.

The CE marking process includes:

  • 确定要求
  • Identifying the appropriate standard (includes involving a Notified Body as needed and creating a test plan)
  • Performing the testing / Applying the standards
  • Compiling technical information (includes completing a Notified Body review if needed and issuing a Statement of Opinion (SoO) if required)
  • Generating a Declaration of Conformity (DoC)
  • CE标记equipment
  • Placing equipment on the market (Putting the product into service)
  • Maintaining compliance through regular testing and auditing

如果您需要关于CE标记过程的指导,以及如何适用于您和您的产品,元素的CE标记培训课程由经验丰富的主题专家提供。他们可以通过灵活的标准和定制包来解决您的问题,并提供最佳实践指导,以满足您的业务和工作人员需求。

CE标记已通知的身体服务
CE标记服务

Testing and Notified Body Services for CE Marking

我们的经验丰富的工程师将对所需标准进行产品测试,并提供全面的报告以支持您的技术文件。我们是电气和机械设备上的领先提供商,包括:

我们还可以提供必要的第三方环境测试to support your risk assessment and identification of hazards. You can combine your testing into a single test program to save time and money.

我们向以下CE标记指令提供通知的身体服务:

Should you want to export your products outside the European Union, our乐动体育软件最新版and全球批准teams can assist in providing the testing and documentation needed to gain access to worldwide markets. With experience helping clients become certified for export to North America, Asia, South Africa and beyond, we leverage our global platform to give your products and your business international reach.

CE标记会员国
CE标记服务

List of CE Marking Member States

CE标记允许您访问欧盟成员国,以及欧洲经济区(EEA)的国家。

CE marking allows you to freely trade your products in the following countries:

  • Austria
  • 比利时
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Denmark
  • Estonia
  • Finland
  • France
  • 德国
  • 希腊
  • Hungary
  • Iceland
  • Ireland
  • 意大利
  • 拉脱维亚
  • Lithuania
  • 卢森堡
  • Malta
  • 荷兰
  • Norway
  • Poland
  • 葡萄牙
  • 罗马尼亚
  • Slovakia
  • 斯洛文尼亚
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom
If your target market is not listed above, please contact ourglobal approvalsteam for more information about how we can help you gain trade access to other countries around the world.

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