Medical device companies and medical translation providers alike are scrambling to meet the new requirements of the EU's updated Medical Device Directive (MDD, 2007/47/EC).
One of the most challenging components of the new directive is the increased focus on language translation for software and labeling. The updated MDD states that software which is integral to the operation of a medical device must be translated into the languages of the countries in which the device will be sold.
In the past, companies have been able to avoid translating software by stating that the great majority of professional device users can read English. Software translation is no small feat. It can be expensive, time-consuming and a minefield for errors. But it doesn't have to be this way. Through implementing some best practices and avoiding common pitfalls, software translations can go smoothly.
Notified bodies are now placing particular emphasis on the risks presented by inaccurate labeling and translations. Inaccuracies in labeling and IFUs can lead to incorrect use of a device, resulting in injury, death, notified body action, lawsuits and bad publicity. The root causes of inaccurate translations are many, but fortunately, these can be sidestepped through careful preparation, translator screening and efficient processes.
Do you know which languages are needed in which European countries? Some of the requirements may surprise you. We have pulled together a helpful chart of the EU countries and their language requirements.
In addition, take a look at three upcoming events dealing with the revised MDD:
- The 2010 MDD Revisions and What They Mean for Translation
- Medical Device Vigilance Planning under the Revised MDD
- Good Auditing Practices for EU Notified Body Audits
ForeignExchange Translations provides specialized software translation and localization services to medical device companies. Contact us to learn more.