Your compliance requirements for export to the EU do not stop with putting the CE marking on your equipment. Depending upon the applicable CE marking Directives that are relevant to your equipment, you may be required to prepare or be able to prepare various translated documents.
There are different requirements for translations in the Directives and you are required to comply with the requirements in each of the Directives that are applicable to your equipment. Broadly, your electrical, electromechanical, and mechanical products with a CE marking require the following to be translated into the national language of the country in Europe to which you send your products:
- Declaration of conformity
- 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
Additionally, upon the request of national authorities, you may be required to translate the technical file for your equipment. That request may include only the aspects of compliance related to the request or the entire technical file. This could mean that the technical reports require translation.
- 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)
We commonly field questions regarding what needs to be translated and why. Since these requirements are listed in the different Directives, the requirements are different by Directive, and can be different based upon your role in the process, a more detailed analysis of the translation requirements follows.
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, 126.96.36.199. 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.
The European Commission provides information regarding what this actually means in the context of what you must do to comply. This is explained in the Guide to application of the Machinery Directive 2006/42/EC, § 245.
Relevant sections are copied below.
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.
The guidance document also provides information in §246 about the official languages of each Member State.
Section 246 The official languages of the EU
There are 23 official EU languages, used in the following Member States:
Austria − German Latvia − Latvian
Belgium − Dutch, French and German
Bulgaria − Bulgarian
Cyprus − English and Greek
Czech Republic − Czech
Denmark − Danish
Estonia − Estonian
Finland − Finnish and Swedish
France − French
Germany − German
Greece − Greek
Hungary − Hungarian
Ireland − English and Irish
Italy − Italian
Latvia − Latvian
Lithuania − Lithuanian
Luxembourg − French and German
Malta − English and Maltese
The Netherlands − Dutch
Poland − Polish
Portugal − Portuguese
Romania − Romanian
Slovakia − Slovak
Slovenia − Slovenian
Spain − Spanish
Sweden − Swedish
United Kingdom − English
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
The translation requirement extends to the instructions (operator and maintenance manual) as well and this is specified in 2006/42/EC, Annex I, 1.7.4. & 188.8.131.52.
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, 184.108.40.206. 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 your CE marking compliance project you will need to write a declaration of conformity and compile a technical file. The requirements for the translation of the declaration of conformity are stated 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 220.127.116.11(a) and (b)), and must be typewritten or else handwritten in capital letters.
The requirements for this are described 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 18.104.22.168 apply.
Note in particular the last line, “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 22.214.171.124 apply.”
This makes it clear: unless you have special instructions from your customer (who must have a valid reason), you must translate the manual and other documents related to operation and maintenance into the official language of the country to which you send the equipment. This can extend to other documents: for instance if you incorporate a bought sub-assembly like a pump that must be serviced then maintenance instructions for it must also be translated. The technical file itself may remain in English since it is an official Community language.
New Legislative Framework (NLF) 2008 CE marking Directives
It is useful to understand the translation requirements specified by the Machinery Directive first because until April 20, 2016 they were the most strenuous. The Low Voltage Directive 2006/95/EC, the EMC Directive 2004/108/EC, and the R&TTE Directive 1999/5/EC specified translations into a Community language only – and that meant English was acceptable. However, with the recast of many CE marking Directives in 2014, followed by their 2016 enforcement dates, this is changed.
The EU’s 2008 New Legislative Framework brought in an alignment of definitions across many of the CE marking Directives and stricter, more clearly defined responsibilities for manufacturers, distributors, and importers. The NLF, as it is called, is based on three documents. The relevant document for US manufacturers exporting to Europe is Decision no. 768/2008/EC, within which the rules governing the responsibilities of manufacturers are listed in Chapter R2, Obligations of economic operators, Article R2, Obligations of manufacturers. See in particular no. 7 and no. 9 from Article R2 below.
- 768/2008/EC, Chapter R2, Article R2 (7.)
Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and end-users, as determined by the Member State concerned.
- 768/2008/EC, Chapter R2, Article R2 (9.)
Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
The text from no.’s 7 & 9 of 768/2008/EC, Chapter R2, Article R2 is repeated in the following places in the below, recast Directives:
- Low Voltage Directive (LVD) 2014/35/EU, Article 6 (7.) & (9.)
- Electromagnetic Compatibility Directive (EMC) 2014/30/EU, Article 7 (7.) & (9.)
- Equipment & Protective Systems for use in Potentially Explosive Atmospheres Directive (ATEX) 2014/34/EU
See Article 6 (8.) & (10.)
- Radio Equipment Directive (RED) 2014/53/EU, Article 10 (8.) & (12.)
- Pressure Equipment Directive (PED) 2014/68/EU, Article 6 (7.) & (9.)
- Restriction of Hazardous Substances (RoHS) 2011/65/EU, Article 13 (2) only
This means that if your project is within the scope of any of the directly above CE marking Directives or the Machinery Directive 2006/42/EC then you will need to make translations of at least the operations and maintenance instructions as well as the declaration of conformity. Keep in mind that in many cases you will need to provide both the original documents in English and the translated documents with the word “Translated,” or “Translated from the original instructions,” printed on them. The words, “Original Instructions,” may need to be printed on the originally drafted instructions.
Medical Devices Directive 93/42/EEC
The Medical Devices Directive 93/42/EEC, aka the MDD, also makes requirements for translations of various documents. These are detailed below.
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.”
Upon review of Annex I (13) “Information supplied by the manufacturer,” we see it includes instructions and maintenance information, labels (including labels on detachable components), recycling information, and other information.
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.”
Article 11 (1-6) includes items dealing with the chosen conformity assessment procedure, including the declaration of conformity. This means that English may be acceptable but that the Notified Body involved in the process may request the information in the language of the member state in which the Notified Body is situated.
The ‘Blue Guide’ on the implementation of EU product rules 2016
The latest revision of the Blue Guide was published on the European Commission’s website on April 5, 2016. This document is made available for use by CE marking professionals, manufacturers, importers, distributors, and authorized representatives. In particular, the preface of the new document instructs that the revision was at least partly initiated by the changes brought on by the 2008 NLF.
Below are references to translation requirements required by the CE marking process. Please note that the Blue Guide is not a law like the Directives. Rather it is a reference document to be used as a guide.
Unabridged paragraphs of abridged sections of the Blue Guide are presented below for review.
4.4 EU Declaration of Conformity, para 7:
The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market. Union harmonisation legislation does not necessarily specify who has the obligation to translate. Logically, this should be the manufacturer or another economic operator making the product available. The EU declaration of conformity must be signed by the manufacturer or his authorised representative. If a translation of the EU declaration of conformity has been produced by another economic operator and is not signed by the manufacturer, a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version.
7.2 Controls by Market Surveillance Authorities, para 16, para 17:
In the case of a reasoned request it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, the request for translation of technical documentation should be limited to these parts of the documentation. If the market surveillance authority considers a translation necessary, it must clearly indicate the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities.
National authority might accept a language they understand and which is different from the national language(s). The language chosen could be a third language, if accepted by that authority.
It is clear that if you are sending equipment to Europe you will need to provide translations of some of the documentation for the product, unless you are shipping to Ireland or the UK. At a minimum you will need to translate the declaration of conformity and the operations and maintenance manuals. You may be required to translate some or all of the Technical File if there is ever a problem or question with your equipment.
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