Translation a Must Have Tool Today

Directives guiding the sale of medical and consumer devices already govern localization in 25 countries of the European Union. The European Union's (EU) Medical Device Directive (93/42/EEC) (MDD) has forced a great many medical device manufactures to recognize the importance of languages other than English and therefore understand the value of translation in today's marketplace.

The Medical Device Directive (93/42/EEC) 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 an 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 on the part of the manufacture and not, 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 language.

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 or her failure to understand instructions which were 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 may 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, poorly translated instructions are worse in some case than no translation at all and can result in the same legal repercussions as 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 to customers in different countries with different languages, 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 itself at a serious disadvantage when trying to sell their English-language product if their competitor offers a similar device in localized versions. Thus, translation - whether legally binding for a specific product or not - simply makes good business sense.

It is understood from the regulatory requirements that translating and localizing your labels and instructions for use will ensure your compliance with the European Medical Directives and allow you to market your products within all 25 EU Member States. But translation and localization also has a commercial, sales and marketing value when penetrating new foreign markets.

It is important to keep in mind that only 14% of the EU market is English speaking. In order to successfully penetrate this market you must convey your message whether it is of a technical or marketing nature in the languages of the target market.

Some of the localization benefits are that it:

• - Ensures correct and safe use of your product
• - Increases awareness of the product in the target country
• - Demonstrates respect and understanding of your target audience by communicating your message in their native language thereby increasing the likelihood of success
• - Allows you to more easily compete with local manufacturers
• - Increases customer satisfaction

Why not use your distributor also as a translator?

Medical translation and localization is a very complex process. It entails several levels of execution and involves several specific industry individuals and professional linguists dedicated to a particular translation project. Your distributor is neither. Be aware, your distributor cannot be responsible for, or be expected to understand the regulatory requirements involving language within each individual member state, since he may also distributes several products from several industries which may not be related to yours. By using your distributor to translate your technical documentation you are putting your factory, product and brand name at risk because you cannot be sure that the translation of your labeling and or instructions for use will meet your needs or EU requirements. Using a professional translation company can ensure that the translations, proof reading and Quality Assurance will be conducted by professionals from the industry and inside the target market you wish to penetrate. As it has been clearly emphasized, accuracy in providing translation services is absolutely crucial. Improper translation is not only detrimental to the end user, but it is a violation of the Directive!

In turn by using professional companies to translate your technical related documentation as well as your marketing and sales literature, especially when dealing with medical devices you are ensuring that your product has meet the requirements for both the professional and non-professional users. Furthermore it ensures compliance with the regulatory requirements of the European Medical Directive therefore minimizing the risk of any misunderstanding due to incorrect translation by someone that is not qualified.