Translation shifts from nice-to-have to must-have
Lee Stein, Net-Translators Ltd.
Directives guiding the sale of medical and consumer devices already govern localization in the 25 countries of the European Union.
The European Union's (EU) Medical Device Directive (93/42/EEC) (MDD) forced a great many medical device manufactures to recognize the fact that there are other languages besides English.
What are the implications from the translation point of view?
For starters, the Directive requires companies to adopt a specific multilingual documentation process. This requirement compels companies to make provisions for translating documents pertaining to their product packaging, end-user instructions, labels, and other essential product documentation. These are 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 specify that national languages may be necessary for this kind of information, most EU member states have now made it clear 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.
There are two basic categories into which product information generally falls: 1) professional use and 2) patient use. User information for devices designed for patient (OTC) use is almost invariably translated into all target market languages. This has to do with common sense, regardless of any specific regulations. With regard to devices designed for professional use, safety-related information is also commonly translated. Their high-level of complexity often makes it advisable to provide information in the user's native tongue.
It is difficult to predict the outcome of a court case in which a manufacturer is sued as a result of a user error stemming from his failure to understand instructions provided in a foreign language. However, the damage to the manufacturer's reputation and business would be done in any case, whether he is legally liable or not.
Often manufacturers will use their own distributor or in-house translators to make their products available in different languages. However, this practice while viewed as a viable way to cut costs often results in poor 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. Thus, badly translated instructions are worse than no translation at all and can result in the same legal repercussions as for no translation. Cutting corners by using this type of translation is clearly not the way to ensure quality.
There is yet another argument in favor of translating medical device material that has little to do with regulatory requirements. As with any product geared for customers in different countries with different mother tongues, it is a matter of user friendliness and a valuable selling point to make it available in the potential clients' native tongues. For example, the German sales force of an MDD manufacturer will find themselves at a serious disadvantage when trying to sell their English-language product if their colleagues from competitor B offer a similar device in duly localized versions. Thus, translation - whether legally binding for a specific product or not - simply makes good business sense.
As has been clearly emphasized, accuracy in providing translation services is absolutely crucial. Improper translation is not only detrimental to the end user it is a violation of the directive! Net-Translators provides translation services in over 60 different languages and offers translation services to manufacturers who must comply with these requirements. All of the more than 1000 translators at Net-Translators are located in the countries where their native language is spoken, ensuring the most precise translations possible.
Once again, the OneLink:OneSolution™ network is offering solutions to firms in the medical device industry concerning one of the most important matters through one of it's partners, Net-Translators.
Lee Stein is the Vice President of Operations of Net-Translators Ltd.