MDD 2007/45/EC and software localization

Spring Cleaning MDD 2007/45/ECSpring is almost here and with it comes the deadline for medical device manufactures to conform to the new Medical Device Directive opens in a new window from the European Community, MDD 2007/47/EC.

Any medical device manufacturer selling products in Europe will have to consult with its notified body to learn of any impact the new directive will have on its products and to gain certification or obtain formal exemptions where qualified.

MDD 2007/45/EC For Translation and Software Localization

From a localization and translation perspective, the new European directive requires that software used in medical devices be localized into the languages of all the EC countries that the product is sold into. This means that the user interface (UI), graphical or otherwise, will need to be in the language of the user.

For quite some time now, medical device manufacturers relied on translation service providers to convert into other languages their labels, inserts, manuals, leaflets, instruction of use and other printed documents necessary for international users to understand and operate their devices. As of March 21st, 2010, medical device manufacturers that incorporate software in their products will have the additional responsibility of shipping localized software with their products, or risk losing their CE marking and therefore be forced to cease selling in key European markets.

Challenges with Medical Translations

Software localization is not as simple as document translation. There are many issues involved that require additional technical expertise and savvy. Files come in different formats, require different character encoding, have real-estate and character size constraints, and require parsing, processing and regeneration without impacting the code that is essential to build and operate the product. Errors unintentionally inserted in the code by inexperienced translators can result into endless debugging hours and significantly extend quality assurance time, leading to higher costs.

Furthermore, software localization processes are very different from document translation. They require a detailed localization kit, different tools, unique Localization QA steps, and more sophisticated implementation strategies. For instance, translation management systems will be essential in maintaining consistency throughout the product, attending to last minute software updates, reporting tickets and addressing out of context UI string translations.

In short, you need software localization experts in addition to subject matter experts, to attend to these new MDD 2007/45/EC needs. Can your current translation vendor handle these new challenges? If not, time may be ripe for a spring cleanup!

Check out GlobalVision’s medical translation services for more information!


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