The European Union's (EU) Medical Device Directive (93/42/EEC) (MDD) forced many medical device manufactures to recognize the need to translate device documentation into other languages. Specifically, the Directive requires companies to adopt a specific multilingual documentation process. This requires companies to make provisions for translating product packaging, end-user instructions, labels and other essential product documentation. The translation of these documents is particularly important when it comes to user instructions since the device's safety and purported performance could be compromised due to incompetent translation.

While previous directives specified that national languages might be necessary for this type of information, most EU member states have now clarified that this has become an absolute requirement. Specifically, the MDD 93/42/EEC Directive Annex I Article 13.1 states that "each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users." This, along with the directive making the potential user's "knowledge" mandatory, makes accurate translation an imperative.

Medical deviceproduct information generally falls into one of two categories: professional use and patient use. User information for devices intended for patient use is almost invariably translated into all target market languages. For marketing purposes, this only makes sense.  Medical devices designed for professional use also usually include safety information translated into the target market's native language.
It is difficult to predict the outcome of a court case in which a medical device manufacturer is sued as a result of a user error that occurred because of a failure to understand instructions provided in a foreign language. However, the damage to the manufacturer's reputation and business would be significant whether he it is legally liable or not.

Often manufacturers will use their own distributor or in-house translators to make their products available in different languages. This practice usually cuts cost but also often results in poor quality translations. Not only is it in the best interest of the manufacturer to continually monitor all printed material for accuracy and consistency, it is essential for credible business practices. Therefore, poorly translated instructions are worse than no translation at all and can result in the same legal repercussions as if there were no translation. Cutting corners by using this type of translation is clearly not the way to ensure quality.

Another argument that favors translating medical device documents that has little to do with regulatory requirements is that it makes good marketing sense. As with any product targeted to overseas markets, it is a matter of user friendliness and a valuable selling point to make it available in the potential clients' native languages. For example, the American sales force of a medical device manufacturer will find itself at a serious disadvantage when trying to sell their English-language product in Germany if the sales force from competitor B offers a similar device in German language versions. Thus, accurate medical translation - whether legally binding for a specific product or not - simply makes good business sense. THE MARKETING ANALYSTS provides medical translation services in most world languages with native-language speakers specializing in the medical device field.  Please visit us at .