The primary objective of the translation is to provide users with clear and understandable guidelines for properly using medical devices.
The most important aspect to keep in mind involves legal issues. Countries in the European Union dictate that the proper translation of instructions of use is a mandatory requirement.
The translation is essential for avoiding legal negative consequences, be it for the manufacturer or distributor of medical devices. Failure to translate instructions properly or in their entirety is considered an infringement and can result in serious penalties for the manufacturer, distributor, or both.
There are three categories of potential consequences. These are very serious, serious, or minor infringements, depending on the degree of damage that may have been caused.
Into which languages should I translate the instructions for use according to the MDR?
The Medical Devices Regulation (MDR) requires an accurate translation of the instructions for use, as they form part of the product’s technical file. The technical dossier needs to be sent with the labeling for revision by the notified bodies.
According to the MDR, the instructions for use must be translated into the 24 official languages of the European Union, depending on the country or countries where the medical device is marketed. The official languages include Bulgarian, Czech, Croatian, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish and Swedish.
What characteristics must a translation of instructions for use comply with?
What symbols are used in the labeling of medical devices?
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If you’re interested in learning more about the current European Union medical device regulations, consider taking a look at our blog.