5 Tips on Translating Medical Device Labeling
Regulatory authorities around the globe view medical device labeling as an integral part of the medical product itself. If you’re a medical device manufacturer with plans to distribute your products abroad, you need to be prepared to meet different medical device labeling requirements around the globe. This should be a top priority because many international standards, such as IEC 60601-1, deem labeling a critical component of a medical device – it’s not just extra paperwork!
All labeling content is carefully reviewed when a medical product is introduced to a new market, and ongoing compliance reviews work to ensure continued reliability. Therefore, it is crucial that these documents – and all medical translations of them – are as accurate as possible. Here’s what you need to know to meet translation requirements for medical device labeling.
What is a medical device label?
According to the FDA, medical device labeling covers “any information associated with a device targeted to the patient or lay caregiver.” These documents provide critical risk/benefit information as well as clear instructions for safe use. They come in a wide range of formats, including brochures, leaflets, user manuals and videotapes – basically, any document containing explanatory information geared toward the patient.
The FDA directive emphasizes that patient labeling must:
- be well-organized
- meet high standards of readability
- contain clear writing and easy-to-read graphics
- highlight important safety information
- be systematically pretested to ensure that it will be comprehensible to the target audience.
The FDA directive, however, does not deal with the actual language in which patient labeling should be written, since it’s clear that medical devices headed for the US market must be documented in English. That is not the case, however, in other parts of the world.
International language guidance
Most countries or regions have their own regulations about labeling medical devices. The EU Medical Device Directive (MDD), for example, stipulates that member states may require medical device information to “be made available to the user and the patient…in their national language(s).”
To make it a little easier for medical device manufacturers and medical translation services to comply with patient labeling requirements around the globe, a Global Harmonization Task Force (GHTF) was established in 1993 to prepare non-binding guidance to regulatory authorities for patient labeling of medical devices. GHTF consisted of a voluntary group of international representatives from regulatory authorities and trade associations in the U.S., Europe, Canada, Japan and Australia.
In September 2011, GHTF published its final report reaffirming the importance of patient labeling being written in understandable language that is supplemented with drawings and diagrams wherever possible. In October 2011, the International Medical Device Regulators Forum (IMDRF) replaced GHTF.
Even without the language requirements of international regulatory bodies, it simply makes good business sense to provide clear and understandable labeling information, translated into the patient’s native language. After all, the efficacy and safety of the product is dependent on proper usage. Here are 5 tips for overcoming multilingual issues in medical device labeling:
1. Use accessible language – Avoid jargon and keep instructions simple. Not only will this kind of language make it easier for English-speakers to understand, it will also make it easier to translate medical labels into the other languages required.
2. Provide documentation electronically – Virtually all regulatory authorities today allow patient labeling to be provided online, as long as it is clear to the end-user where that information can be accessed. Digital deployment makes it easier to provide labeling in multiple languages without adding bulky documentation to the device packaging. It also makes it easier to keep information up-to-date.
3. Use graphics liberally – Patient labeling is a classic case where a picture is worth a thousand words – in any The FDA directive goes into great detail about how to effectively incorporate graphics. For example, it recommends making graphics large enough to convey the focal point, using dark, sharp lines for good contrast, and adding cues such as circles or arrows to highlight key information.
4. Use internationally recognized symbols and icons – Many symbols and icons have become standardized and should be used wherever possible in patient labeling to overcome language barriers. However, it is incumbent on the manufacturer to ensure that the symbols and icons will be properly understood by any given target audience – which is why pretesting and localizing of patient labeling content is critical.
5. Use videos or animations – Supplement classic instruction manuals with engaging videos or animations that contain minimal text and maximum imagery.
Start early, finish ahead
The complicated process of patient labeling is easier to manage if its multilingual components are addressed strategically from the beginning. Clearly translated medical content and a rich array of graphical elements will ensure that the labeling makes sense across a wide range of target languages.