Translation Shifts From Nice-to-Have to Must-Have
Shy Avni, 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:
i) professional use and ii) 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 300 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:OneSolutionT 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.
Shy Avni is the Business Development Director of Net-Translators Ltd.
Net-Translators specializes in Translation and Localization services in over 60 languages for the biotechnology industry.
Learn more about Net-translators Bio-Technology Translation Services
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