Translating the documents that accompany medical devices is a vital part of the regulatory process for exportation and distribution into international markets. In the European Union (EU) alone, there are 24 official languages, and most of the member states require a translation into at least one of their official languages – Belgium, for example, requires French, German and Dutch translation services. This can get costly for manufacturers, so many look for ways to cut back…
Exporting Medical Devices and Translation
The export and distribution of medical devices into a foreign market must undergo a stringent regulatory approval process, with a unique set of regulations in each country. Although these regulations differ, they have one common requirement: medical device documentation translation.
Content accompanying the product must be submitted in certain languages spoken by target users. Documentation must be translated into the official language(s) of the country in which the device will be used.
This includes:
- Packaging and Labels
- Instructions For Use (IFU)
- User Interface and Software
- Marketing Materials
- Patient or Caregiver-focused Documentation such as Technical Information or Patient Literature.
The majority of EU member states, 22 out of 28, require medical device labeling in their official language regardless of whether the device is intended for layman use or professional use. As such, this can get quite expensive for medical device manufacturers, especially if there are many languages in which the documentation needs to be translated.
Medical Devices | Do You Always Have to Translate?
It is possible to obtain permission to distribute a medical device in another country without undergoing medical device documentation translation for corresponding texts. This can greatly reduce costs.
In order to receive permission to be exempt from translation, a foreign medical device company must have a specific reason for the request. The exemptions are also primarily allowed when the source text is written in English.
To date six EU member states accept labeling medical devices in English as long as the device is for professional use only. Some regulatory authorities may also be willing to limit the translation requirement to the device identification label and to operating and safety information.
Risks and Liability of Only Providing Limited Translations in English
But even then, translating medical device documentation such as manuals and descriptions might still be the best option. While English is the most widespread second language learned and spoken all over the world, it is still not ubiquitous.
Healthcare professionals might be very proficient casual English speakers, especially in Europe, but medical terminology could be more difficult to communicate accurately. Patients on the other hand should not be expected to have a fluent level of English.
Another way to reduce costs for medical device translation is by decreasing the amount of text prior to undergoing the translation. However, the most important question to ask when considering this is whether a person who speaks a different native language will be able to comprehend the abbreviated text, and whether the edited version is sufficient.
For obvious reasons this can lead to misuse of a medical device. In the event of an accident the producer is liable to pay. Either injury to a person or causing damages to the machine due to an untranslated text can result in costly compensation.
This does not only apply when the producer sells their own device, but also if the producer chooses to use a local company to sell its product in a foreign country. That company is also required to ensure users in the target market are able to understand how to use the device.
Staying Up To Date With Labeling & Translation While Cutting Costs
On top of ensuring that users comprehend how to use your medical device from the onset, devices also evolve along with changes in technology. The accompanying documentation and software must therefore be regularly updated in all required languages.
Thus, translation requirements do not end with labeling and marketing. Manufacturers remain liable for their devices throughout their lifespan, and it is their responsibility to closely monitor the changes in regulatory requirements for the countries where their equipment is distributed.
While translation of medical device labeling is mostly a legal requirement, often it is also a risk-related or effective marketing decision.
One way manufacturers looking to reduce translation costs can achieve their goals, while still providing an adequate amount of information in users their native languages, is through e-Labeling. This process, which is the act of providing the medical device label information online instead of physically on the machine, has the potential to cut down costs associated with delivering device information to users.
This is especially true for companies doing business in the EU. The method is becoming more popular not only for being cost effective, but also in terms of efficiently maintaining and delivering the most up-to-date information for all users.
Thorough Translation Is The Safest Option To Avoid Costly Mistakes
Prevention of injury is of course one of the biggest driving factors behind the language specific medical device labeling requirements. That’s why providing proper translation in the native languages of target foreign markets is so important.
As technology and access to online resources advances, e-Labeling has the potential to be an effective solution for manufacturers looking to harmonize cost reduction and provision of adequate patient information.
Pursuing English only, and abbreviated translations is still a possibility. If there is any doubt, a good medical device translation services provider should be able to advise you on whether or not a translation of certain text is necessary, and can also provide you with further information about language demographics in your target markets.
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