Certified Translation of Instructions for Use for Medical Devices

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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?

It is critical to specify whether the instruction manual is an original iteration or a translated version of the original manual. If it is a translated version, it must be an accurate and faithful translation of the original and, at the same time, be accompanied by the original manual. It is also necessary to translate the entire instruction manual, especially the safety aspects of the medical device in question. According to the MDR, the instructions must clearly outline the specific infrastructure, or necessary context, required for the use of the product. Additionally, information should be provided to properly determine when the device should not be used again. There are other important issues that should be considered when working with instructions for use. These includes warnings and precautions for the proper and safe disposal of the device. Additionally, there should be notifications that instruct the user and/or patient on when and how to report a serious incident with the medical device to the manufacturer and competent authority of the Member State where the user and/or patient is located.

What symbols are used in the labeling of medical devices?

Throughout the article, we elaborated on the importance of translating the instructions for use. Here is another important issue to keep in mind: the labeling of medical devices. Both the instructions for use and labeling must be written in the official language of the country in which the product is to be marketed, according to ISO 15223-1:2013. Medical devices must bear the CE marking. This mark certifies that the product complies with the safety, health, and environmental protection requirements set forth by the European Union. Additionally, as a manufacturer, you must include the relevant pictograms applicable to your product. Some of the symbols refer to the name and address of the manufacturer, the authorized representative in the European Union, date of manufacture, expiration date, batch code, catalog number, and warnings, among others. Our team of linguists is specialized in the technical field and is tasked with translating user manuals, preserving the meaning of technical terms, and ensuring the end-user will understand and use them in a practical way.

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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.