| The European Union's (EU) Medical Device Directive | | | | one of two categories: professional use and patient |
| (93/42/EEC) (MDD) forced many medical device | | | | use. User information for devices intended for patient |
| manufactures to recognize the need to translate | | | | use is almost invariably translated into all target |
| device documentation into other languages. | | | | market languages. For marketing purposes, this only |
| Specifically, the Directive requires companies to adopt | | | | makes sense. Medical devices designed for |
| a specific multilingual documentation process. This | | | | professional use also usually include safety information |
| requires companies to make provisions for translating | | | | translated into the target market's native language. |
| product packaging, end-user instructions, labels and | | | | It is difficult to predict the outcome of a court case |
| other essential product documentation. The | | | | in which a medical device manufacturer is sued as a |
| translation of these documents is particularly | | | | result of a user error that occurred because of a |
| important when it comes to user instructions since | | | | failure to understand instructions provided in a foreign |
| the device's safety and purported performance could | | | | language. However, the damage to the |
| be compromised due to incompetent translation. | | | | manufacturer's reputation and business would be |
| While previous directives specified that national | | | | significant whether he it is legally liable or not. |
| languages might be necessary for this type of | | | | Often manufacturers will use their own distributor or |
| information, most EU member states have now | | | | in-house translators to make their products available |
| clarified that this has become an absolute | | | | in different languages. This practice usually cuts cost |
| requirement. Specifically, the MDD 93/42/EEC | | | | but also often results in poor quality translations. Not |
| Directive Annex I Article 13.1 states that "each | | | | only is it in the best interest of the manufacturer to |
| device must be accompanied by the information | | | | continually monitor all printed material for accuracy |
| needed to use it safely and to identify the | | | | and consistency, it is essential for credible business |
| manufacturer, taking account of the training and | | | | practices. Therefore, poorly translated instructions are |
| knowledge of the potential users." This, along with | | | | worse than no translation at all and can result in the |
| the directive making the potential user's "knowledge" | | | | same legal repercussions as if there were no |
| mandatory, makes accurate translation an imperative. | | | | translation. Cutting corners by using this type of |
| Medical device product information generally falls into | | | | translation is clearly not the way to ensure quality. |