When it comes to the European Union's CE certification, CE marking directives and testing processes can be notoriously complex. If you don't have a background in product safety or regulatory compliance, complying with these regulations may seem overwhelming. However, this blog will guide you through the steps involved in getting your electrical or electronic product certified, and thereby being eligible for sale in Europe.
The CE mark is required for products that fall under the scope of one of the EU directives. The CE marking is not required for products that are not covered by any of these directives. We are looking at Electronic and Electrical products here and so we'd be thinking about the Machine Directive 2006/42/EC, the Low Voltage Directive 2014/35/EC, and the Electromagnetic Compatibility Directive 2014/30/EU.
A product that does not carry a CE mark must be accompanied by documentation stating that it does not need to comply with all relevant EC Directives and laws and that there are no additional requirements for placing on the market in another member state.
If you want to sell your products within the European Economic Area (EEA), you need to ensure that your product complies with applicable national standards in each country as well as EU standards.
Once you've determined that your product meets the requirements of your target country's relevant directives, standards, and harmonized standards, you'll need to ensure that it also adheres to any national standards. This may include legal or administrative provisions such as:
Under the requirements of all Directives, a third-party assessment is mandatory. The distinction is whether or not this assessment must be completed by a Competent Authority or a Notified Body.
A Notified Body is typically required for higher risk products (medical devices, pressure equipment, etc.). A Notified Body will provide a full certification to CE marking requirements. There is no self-declaration available using this compliance path.
A competent authority is typically required for lower risk products (TV’s and toasters, etc.). Competent Authorities provide third party test reports and support a manufacturer’s own self-declaration. The manufacturer is ultimately responsible for their product in market and must be able to show compliance to the directives and standards applicable to their products.
Once you’ve determined which directives your product is subject to, you need to review the testing and certification requirements for each directive. You can find these requirements on the European Commission website.
The types of testing and certification requirements will depend on the product and its intended use. For example, if you want to sell an electronic device with a wireless module in Europe, you must meet the EMC Directive’s requirements for electromagnetic compatibility (EMC).
The CE mark must be visible, readable, and legible. It must be placed in a visible, readable, and legible position on the product or its packaging. The CE marking should not be obscured by other labels or parts of the product it is affixed to.
For most products shipped into the EU the self-declaration process of demonstrating compliance is the most common method, as such, we will expand on that here. Risk assessments are required for most products subject to CE marking. You need to review your product to determine if it poses a risk. Identify the potential hazards associated with its use in “normal” and “abnormal” conditions, as well as how these might combine during an incident or failure mode.
The technical construction file (TCF) contains information about your product and how it complies with EU legislation. It includes drawings, descriptions, material specifications/certifications – all related information that helps ensure each part is safe for consumers by providing insight into how they were produced or manufactured.
The TCF must be submitted to the manufacturer, importer, or distributor of the product. It should be kept for 10 years after being issued.
The CE mark is a mandatory marking for products that are sold in the European Union. It indicates that your product complies with all relevant directives and regulations, and you should use it on all applicable products.
In many cases, it's possible to handle the CE mark process yourself (self-declaration using a Competent Authority third party), but the complexity of the CE marking directives and testing processes may make this a daunting task. Partnering early with a Competent Authority or Notified Body is the best approach to ensure that you are choosing the appropriate compliance path for your products. Notified Bodies and Competent Authorities are experts in their field and independent from manufacturers and suppliers, offering third-party, unbiased assessments of your product. TÜV SÜD is both a Competent Authority and Notified Body in the EU.
TÜV SÜD has worked with a wide range of companies to help them with the CE marking process. We can help you determine the correct compliance path to choose for CE Marking. Our team will also conduct any necessary testing and provide a report on the results.
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