Translating Product Documentation into Another Language

From one of our customers

We have a question as to whether there is a legal requirement to supply documentation in a local language, such as French, if supplying equipment into France.

This is not a question specifically for France, but supplying equipment to any other country.

If the answer is yes, what documentation is required to be translated?

I hope you can help.

The New Legislative Framework EU Directives (e.g. Radio Equipment, EMC, Low Voltage) have similar wording regarding translation of instructions and information into the language of the EU Member State

EMC Directive

Obligations of manufacturers

7. Manufacturers shall ensure that the apparatus is accompanied by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.

Blue Guide page 36 (pdf page 38)


4. accompany the product with instructions and safety information (110) (111) as required by the applicable Union harmonisation legislation (
112), in a language easily understood by consumers and other end-users, as determined by the Member State concerned (113). Unless otherwise specified in specific legislation, instructions and safety information need to be provided (114), whether the product is intended for consumers or other end-users.

This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product.

Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by nonprofessionals, the design and instructions accompanied must take this possibility into account. Instructions and safety information must be clear, understandable and intelligible;

 

So yes, information should be translated into the local language, especially where it conveys information critical to compliance with Directives or Laws. I would list this as at least:

  • EU Declaration of Conformity
  • Product manual, instructions, quick start guide
  • Any text on safety specific labels e.g. warning, hot. This is where IEC defined symbols such as warning triangles come in handy
  • Product label

The Regulatory Technical Documentation (Technical File) would be exempt from this requirement. This document is not meant for users / customers of the product. Rather it is for market enforcement authorities only.

EMC Directive

9.   Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the apparatus with this Directive, 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 apparatus which they have placed on the market.

My understanding of this requirement would be that the Technical Documentation should be available in one of the EU member state languages.

Official languages of the EU are listed here.

In the context of medical devices, but broadly applicable to any electronics product, this table from Mastermind Translations is a good starting point. Belgium, Finland, Ireland, Luxembourg, and Malta have multiple options for languages.

Image is “Tower of Babel” by M. C. Escher.