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 required for all manufacturers who sell products in the European Economic Area (EEA). CE Marking allows for the “CE” symbol to be attached to a product and is sometimes referred to as a European Trade Passport since it allows companies to freely sell their products throughout European markets.

CE Marking was previously known as an EC Mark, and has been said to stand for an abbreviation of the French term “Conformité Européenne,” and alternatively to stand for “Comunidad Europea”, “Comunidade Europeia” and “Comunità Europea”, meaning “European Community.”

CE Marking was set up to harmonize the different requirements across all European nations making it simpler and more efficient for companies and organizations to trade across Europe. CE Marking shows that industrial products are in compliance with EU legislation and able to be sold within the EEA.

Many people commonly refer to CE Marking as a quality mark when in reality it is a safety mark, meaning that the product has been assessed and complies with all requirements (safety, health, environmental protection) to be sold in the European Union.

What Languages Are Required For CE Marking?

While the directives do not specify any particular required languages, they do mandate that translations be made into the official languages of each particular country.

Countries may further designate required languages and typically designate the language(s) used by the majority of the population. For example, France requires French, Belgium requires French, Dutch and German, Luxembourg requires French, German and Luxembourgish, and … well, you get the idea.

It is important to contact the appointed Competent Authority in each country for guidance regarding that country’s 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).

Austria France Liechtenstein Romania
Belgium Germany Lithuania Slovakia
Bulgaria Greece Luxembourg Slovenia
Croatia Hungary Malta Spain
Cyprus Iceland Netherlands Sweden
Czech Republic Ireland Norway Switzerland
Denmark Italy Poland Turkey
Estonia Latvia Portugal United Kingdom
Finland

 

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. To get a special exemption requires a separate application to each country’s Competent Authority. These applications require a convincing case for a professional exemption.

The process of getting an exemption takes a lot of time and money and few have been awarded. There have been a few professional exemptions granted under the In Vitro Diagnostic Directive.

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, but any liability that comes from mistranslations remains with the manufacturer.

Relying on distributors can be risky because distributors may distribute multiple products from multiple industries and may lack the industry-specific knowledge and language expertise to adequately translate the required documents. Distributors may not be reliable to understand every regulatory requirement for every individual country for which they will distribute your product or device.

In-country employees may be fluent in the local language, but are not trained translators. Also it is not likely that they are familiar with their specific applicable CE Marking requirements.

Professional translation companies use industry experts who are knowledgeable about CE Marking regulatory requirements to provide translation, editing and proofing. Further, high quality translation companies provide certificates of translation accuracy.

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