PoliLingua Translation Services: CE Marking
CE Marking is a mandatory standard requirement for the vast European Single Market. The process can often be quite confusing and complex and can take up a lot of a company’s invaluable time. An essential CE Marking checklist priority, in this regard, is translation of relevant documentation. That is why PoliLingua is here for you – to provide top quality, credible, and affordable assistance with your CE Marking translation needs. Our linguists are industry experts who are well-versed in CE Marking regulatory requirements to offer excellent translation, editing, and proofreading. Moreover we provide certificates of translation accuracy. At PoliLingua we value accountability and transparency and are dedicated to consistently following the specification agreed with the client. To receive a free quotation, please fill out the form and attach your document. A translation project manager will receive the request and respond with a detailed quotation as soon as possible. If you would like to speak to a project manager, please give us a call at:
Defining CE Marking
The letters ‘CE’ indicate that the product may be legally sold in the European Economic Area (EEA). They demonstrate that the product was verified and found compliant with safety, public health, energy efficiency and/or environmental and consumer protection standards. Thus each Member State must accept CE-marked products without requiring any further testing concerning the requirements set forth in the new approach directives. CE Marking promotes fair competition by holding all companies accountable to the same rules.
Previously designated EC mark, CE stood for “Communauté Européenne”, “Comunidad Europea”, “Comunidade Europeia” and “Comunità Europea”, meaning “European Community.” Currently CE is an acronym for “Conformité Européenne” – French for “European Conformity.” Additionally, CE Marking is at times referred to as a European Trade Passport since it authorizes manufacturers to freely sell their products throughout European markets.
Countries That Require CE Marking
CE Marking is required for 28 EU member states and the EFTA (European Free Trade Association) countries – Iceland, Liechtenstein, and Norway. CE Marking is also compulsory for all products made in outside countries that sell in the European Economic Area (EEA). CE Marking is not required for Central European Free Trade Agreement (CEFTA) countries, but several of them are candidates for EU membership and implement CE Marking standards, including Macedonia, Montenegro, and Serbia.
Language Requirements and CE Marking
The directives demand 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 guidance regarding concerned country’s language requirements, manufacturers are advised to check with the appointed Competent Authority in each country.
List of languages as adopted into National Law by each EU State:
EFTA Countries in Red
Austria - German
Belgium - Dutch, French, German
Bulgaria - Bulgarian
Croatia - Croatian
Cyprus - Greek or English
Czech Republic - Czech
Denmark - Danish
Estonia - Estonian
Finland - Finnish, Swedish
France - French
Germany - German
Greece - Greek
Hungary - Hungarian
Iceland - Icelandic
Ireland - English
Italy - Italian
Latvia - Latvian
Liechtenstein - German
Lithuania - Lithuanian
Luxembourg - French, German
Macedonia (Pending EU State) - Macedonian
Malta - Maltese or English
Montenegro (Pending EU State) - Montenegrin
Netherlands - Dutch
Norway - Norwegian
Poland - Polish
Portugal - Portuguese
Romania - Romanian
Serbia (Pending EU State) - Serbian
Slovakia - Slovak (Some Czech accepted, be sure to clarify first)
Slovenia - Slovenian
Spain - Spanish
Sweden - Swedish
Switzerland - French, German, Italian
Turkey (Pending EU State) - Turkish
United Kingdom - English
Product Categories That Require CE Marking
CE Marking is required for 22 product categories covered in specific directives. The general rule is that machinery, electrical, and medical products that can potentially be hazardous if misused are covered in CE Marking directives. Hyperlinks to the directives can be accessed following the EFTA and EC New Approach website.
List of product groups subject to CE Marking directives:
- Active Implantable Medical Devices
- Appliances Burning Gaseous Fuels
- Cableway Installations Designed to Carry Persons
- Chemical Substances (REACH)
- Construction Products (CPD & CPR)
- Eco-design of energy-related products
- Eco-Management and Audit Scheme (EMAS)
- Electromagnetic Compatibility (EMC)
- Equipment and Protective Systems in Potentially Explosive Atmospheres (ATEX)
- Explosives for Civil Uses
- Garage Doors
- Gas Appliances (GAD)
- Hot-water Boilers
- In Vitro Diagnostic Medical Devices
- Low Voltage Equipment (LVD)
- Machinery (MD)
- Measuring Instruments (MID)
- Medical Devices (MDD)
- Noise Emission in the Environment
- Non-Automatic Weighing Instruments (NAWI)
- Packaging and Packaging Waste
- Personal Protective Equipment (PPE)
- Pressure Equipment (PED)
- Pyrotechnic Articles
- Radio and Telecommunications Terminal Equipment (RTTE)
- Recreational Craft
- Restriction of the Use of Certain Hazardous Substances (RoHS)
- Toy Safety
- Simple Pressure Vessels
Documents That 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). Broadly, sections of documentation and materials related to safety must be translated. However, a number of companies opt to translate extra supporting materials, such as marketing materials and information sheets that accompany their products.
There are different requirements for translations as specified in the directives. As a rule, electrical, electromechanical, and mechanical products with a CE Marking require the following to be translated into the national language of the European country to which the manufactures exports the products:
- Declaration of conformity
- Machinery Directive 2006/42/EC – see 2006/42/EC, Annex II (1.) (A.)
- Low Voltage Directive 2014/35/EU – see 2014/35/EU, Article 15 (2.)
- EMC Directive 2014/30/EU – see 2014/30/EU, Article 15 (2.)
- ATEX Directive 2014/34/EU – see 2014/34/EU, Article 14 (2.)
- Radio Equipment Directive 2014/53/EU – see Article 18 (2.)
- Pressure Equipment Directive 2014/68/EU – see 2014/68/EU, Article 17 (2.)
- Medical Devices Directive 93/42/EEC – see 93/42/EEC, Article 4 (4.)
- RoHS Directive 2011/65/EU – see 2011/65/EU, Article 13 (2.)
- Operations and maintenance manuals
- Machinery Directive 2006/42/EC – see 2006/42/EC, Annex I (1.7.4.)
- Low Voltage Directive 2014/35/EU – see 2014/35/EU, Article 6 (7.)
- EMC Directive 2014/30/EU – see 2014/30/EU, Article 7 (7.)
- ATEX Directive 2014/34/EU – see 2014/34/EU, Article 6 (8.)
- Radio Equipment Directive 2014/53/EU – see 2014/53/EU, Article 10 (8.)
- Pressure Equipment Directive 2014/68/EU – see 2014/68/EU, Article 6 (7.)
- Medical Devices Directive 93/42/EEC – see 93/42/EEC, Article 4 (4.)
- RoHS Directive 2011/65/EU – no requirement
In addition, upon request of national authorities, the manufacturer may be required to translate the technical file for the equipment. That request may include solely the aspects of compliance related to the request or the whole technical file, which might necessitate translations of technical reports.
- Technical File
- Machinery Directive 2006/42/EC – see Annex VII (A.): English is acceptable
- Low Voltage Directive 2014/35/EU – see 2014/35/EU, Article 6 (9.)
- EMC Directive 2014/30/EU – see 2014/30/EU, Article 7 (9.)
- ATEX Directive 2014/34/EU – see 2014/34/EU, Article 6 (10.)
- Radio Equipment Directive 2014/53/EU – see Article 10 (12.)
- Pressure Equipment Directive 2014/68/EU – see 2014/68/EU, Article 6 (9.)
- Medical Devices Directive 93/42/EEC – no translation requirement
- RoHS Directive 2011/65/EU – see 2011/65/EU, Article 7 (j)
Machinery Directive 2006/42/EC
Annex I, 1.7.1. Information and warnings on machinery
Information and warnings on the machinery should preferably be provided in the form of readily understandable symbols or pictograms. Any written or verbal information and warnings must be expressed in an official Community language or languages, which may be determined in accordance with the Treaty by the Member State in which the machinery is placed on the market and/or put into service and may be accompanied, on request, by versions in any other official Community language or languages understood by the operators. Annex I, 18.104.22.168. Information and information devices
The information needed to control machinery must be provided in a form that is unambiguous and easily understood. It must not be excessive to the extent of overloading the operator.
Visual display units or any other interactive means of communication between the operator and the machine must be easily understood and easy to use.
Further information concerning what this translates into in the context of what the steps the manufacturer must take to comply is set forth in the Guide to application of the Machinery Directive 2006/42/EC, §245. Following are pertinent section citations
Section 245 Information and warnings on the machinery
The requirements set out in section 1.7.1 concern the form of information and warnings that are part of the machinery.
The first sentence of section 1.7.1 advises manufacturers to use readily understood symbols or pictograms for this purpose.
Well designed symbols or pictograms can be understood intuitively and avoid the need for the translation of written or verbal information. The second sentence of section 1.7.1 applies when information is provided in the form of written words or text on the machinery, on a monitor screen or in the form of oral text provided, for example, by means of voice synthesiser. In such cases the information and warnings must be provided in the official language or languages of the Member States in which the machinery is placed on the market and/or put into service. The user of machinery may also request the manufacturer to provide the information and warnings on the machinery or on monitor screens accompanied by versions in any other language or languages of the EU that are understood by the operators. This may be for various reasons, for example:
− the persons who are to use the machinery do not understand the official language of the Member State concerned;
− the machinery is to be used in a workplace that has a single working language other than the official language(s) of the Member State concerned; − the machinery is to be used in one Member State and maintained by technicians from a different Member State;
− remote diagnostics are to be carried out in a Member State different from the Member State where the machinery is to be used. Providing information or warnings on the machinery in EU languages other than the official language(s) of the Member State in which the machinery is placed on the market and/or put into service or in any other language(s) is a matter to be settled by contract between the manufacturer and the user when the machinery is ordered.
Section 246 The official languages of the EU
There are 23 official languages… (with the accession of Croatia in 2013, there are 24 official EU languages, see table above).
Certain of the Member States with two or more official languages (Belgium, Finland) accept the use of one language only in areas where only that language is spoken. Manufacturers are advised to check this with the national authorities concerned. Other Member States with two official languages (Cyprus, Malta and Ireland) accept the sole use of English. In the other countries where the Machinery Directive applies in virtue of the EEA, the MRA between Switzerland and the EU-Turkey Customs Union, the national provisions implementing the Machinery Directive require the use of the official language(s) of the country concerned: Iceland - Icelandic Switzerland - French, German and Italian Liechtenstein - German Turkey - Turkish Norway - Norwegian
Besides, the translation requirement covers the instructions (operator and maintenance manual) as stated in 2006/42/EC, Annex I, 1.7.4. & 22.214.171.124.
Annex I, 1.7.4. Instructions
All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.
The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.
By way of exception, the maintenance instructions intended for use by specialised personnel mandated by the manufacturer or his authorised representative may be supplied in only one Community language which the specialised personnel understand.
The instructions must be drafted in accordance with the principles set out below.
2006/42/EC, Annex I, 126.96.36.199. General principles for the drafting of instructions
(a) The instructions must be drafted in one or more official Community languages. The words ‘Original instructions’ must appear on the language version(s) verified by the manufacturer or his authorised representative.
(b) Where no ‘Original instructions’ exist in the official language(s) of the country where the machinery is to be used, a translation into that/those language(s) must be provided by the manufacturer or his authorised representative or by the person bringing the machinery into the language area in question. The translations must bear the words ‘Translation of the original instructions’.
(c) The contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereof.
(d) In the case of machinery intended for use by non-professional operators, the wording and layout of the instructions for use must take into account the level of general education and acumen that can reasonably be expected from such operators.
Upon completion of the CE marking compliance project, the manufacturer has to write a declaration of conformity and compile a technical file. The requirements for the translation of the declaration of conformity are specified in 2006/42/EC, Annex II (1.) (A.) (para 1):
This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I, section 188.8.131.52(a) and (b)), and must be typewritten or else handwritten in capital letters.
The respective requirements are enunciated in 2006/42/EC, Annex VII, A. technical file for machinery (para 1):
This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the requirements of this Directive. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 184.108.40.206 apply…
The technical file must be compiled in one or more official Community languages, except for the instructions for the machinery, for which the special provisions of Annex I, section 220.127.116.11 apply.
Medical Devices Directive 93/42/EEC (MDD)
Article 4 Free movement, devices intended for special purposes (4.)
“Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.”
Article 11 Conformity assessment procedures (12.)
“The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.”
Responsibility for CE Marking
Typically, the manufacturer is in charge of CE Marking. However, a private labeler that presents oneself as the producer or an entity that considerably modifies the product so that it is regarded a ‘new’ product may also be responsible for CE Marking. It is noteworthy that irrespective of who translates the documentation, liability remains with the manufacturer or original producer who attaches the CE Marking.
Enforcement of CE Marking
Enforcement procedures for CE Marking are assured by Customs Officials, and may additionally be initiated by a complaint from a competitor or an unsatisfied customer, by random checks, by government inspectors, or by accident investigators. In this regard, translations are a checklist priority, and failure to provide translation into a specific language may instigate an investigation response from the regulatory body that would mandate that the company explicate its decision not to translate into said language.