9 Answers to CE Marking Questions and Translation Requirements

This year Croatia becomes the 28th EU member state to require CE Marking. This means that manufacturers will be able to place products, devices and machines on the Croatian market, but those items must have documentation in the Croatian language. After reading the above sentence you may find yourself asking, “what is CE marking, and what does it have to do with translation?” This article is my attempt to explore and explain CE Marking and CE Marking translation requirements.

What Is CE Marking?

A CE Marking (also known as a CE Mark) is mandatory for all manufacturers selling products in the European Economic Area (EEA). This certification allows companies to affix the “CE” symbol to their products, often called a European Trade Passport, since it enables free trade across European markets.

Previously known as an EC Mark, CE Marking has multiple interpretations. Some say it stands for the French term Conformité Européenne, while others link it to Comunidad Europea, Comunidade Europeia, or Comunità Europea, all meaning “European Community.”

The CE Marking system simplifies trade by harmonizing regulatory requirements across European nations. It ensures products comply with EU legislation, allowing companies to sell them legally within the EEA.

Many mistakenly view CE Marking as a quality certification, but it serves as a safety designation. It confirms that the product meets all necessary safety, health, and environmental protection regulations for sale in the European Union.

What Languages Are Required For CE Marking?

The directives do not specify required languages, but they do mandate translations into each country’s official languages.

Individual countries may impose additional language requirements, typically aligning with the languages spoken by the majority of their population. For example, France requires French, Belgium mandates French, Dutch, and German, and Luxembourg requires French, German, and Luxembourgish—you get the idea.

To ensure compliance, companies should contact the appointed Competent Authority in each country for guidance on specific language requirements.

What Countries Require CE Marking?

CE Marking is required for the EU member states and EFTA (European Free Trade Association) countries, including Iceland, Norway and Liechtenstein. CE Marking is also mandatory for all products made outside countries that sell in the European Economic Area (EEA).

CE marking is not required for Central European Free Trade Agreement (CEFTA) countries, but some of them are candidates for EU membership, including Macedonia, Montenegro and Serbia and adopt many CE Marking standards.

What Products, Devices Or Machines Require CE Marking?

CE Marking is required for 22 product categories that have specific directives. A basic rule of thumb is that machinery, electrical and medical products that can potentially cause harm if not used properly have CE Marking directives.

What Must Be Translated For CE Marking?

Importing countries under CE Marking require translation of labeling, instructions for use, packaging and user manuals into their designated language(s). Typically, portions of documentation and materials related to safety must be translated.

Who Is Responsible For The CE Marking?

Generally, the manufacturer is responsible for CE Marking. However, a private labeler that presents itself as the producer or an entity that changes the product to the extent that it is considered to be a new product may also be responsible for CE Marking. It is important to remember that regardless of who translates the required documentation, liability remains with the manufacturer or original producer who affixes the CE Marking.

Some companies write into their agreements that the distributor, agent or end user is responsible for translations, but that does not cover those companies. Transferring the responsibility for translation does not transfer responsibility from liability.

What Happens If We Fail To Comply With CE Marking?

Enforcement for CE Marking is performed by custom officials, and can also be triggered by a complaint from a competitor or an unhappy customer, by random checks, by government inspectors or by accident investigators.  Competent Authorities have made translations a checklist priority.

Failure to comply with CE Marking can cause an investigation response from a regulatory body. Failure to include translation into a specific language may prompt the regulatory body to require the company to clarify and explain its decision not to translate into that language.

If We Specify “For Professional Use Only” Must We Still Provide Translations?

Stating that your product is “For Professional Use Only” requires a special exemption from the Competent Authority. However, obtaining this exemption is not straightforward. Each country’s Competent Authority requires a separate application, and these applications must present a compelling case for why a professional exemption is necessary.

Moreover, the exemption process is both time-consuming and costly, with approvals being rare. While a few professional exemptions have been granted under the In Vitro Diagnostic Directive, they remain the exception rather than the norm.

Why Is Using Professional Quality Translators Important?

Companies may choose to have their distributors, in-country employees, or third parties translate their materials to obtain CE Marking. However, any liability resulting from mistranslations remains with the manufacturer.

Relying on distributors, in particular, can be risky. Since distributors often handle multiple products across various industries, they may lack the industry-specific knowledge and language expertise necessary to accurately translate regulatory documents. Moreover, they may not be fully equipped to understand every regulatory requirement for each country where they distribute your product or device.

Similarly, in-country employees may be fluent in the local language, but they are not trained translators. Additionally, they are unlikely to have a deep understanding of the specific CE Marking requirements that apply to your product.

On the other hand, professional translation companies offer a more reliable solution. They use industry experts who are well-versed in CE Marking regulatory requirements to ensure accurate translation, editing, and proofing. Furthermore, high-quality translation providers go a step further by offering certificates of translation accuracy, giving you added assurance in regulatory compliance.