Regulatory authorities around the globe view medical device labeling as an integral part of the medical product itself. 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 videos – basically, any document containing explanatory information geared toward the patient.
When a medical device is introduced to a new market, all labeling content is carefully reviewed for compliance with local rules and regulations. Any problems with the way the labeling is worded could result in a delay in distribution, a product recall or adverse events with patients. That’s why it’s critical that these documents – and all medical translations of them – are as accurate as possible from the beginning. So, check out the following five tips to learn more about overcoming multilingual issues in medical device labeling.
Tip #1: Use accessible language
The efficacy and safety of a medical device is dependent on proper usage. Be sure to 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.
Tip #2: Provide documentation electronically
Some regulatory authorities require medical device labeling to be provided online, and it should be 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.
Tip #3: Use graphics liberally
Medical device labeling is a classic case where a picture is worth a thousand words when incorporated effectively. Try making graphics large enough to convey the focal point. Use dark, sharp lines for good contrast, and add cues such as circles or arrows to highlight key information.
Tip #4: Use internationally recognized symbols and icons
Many symbols and icons have become standardized and should be used wherever possible in medical device 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 medical labeling content is critical.
Tip #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 medical device 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. If you need help translating your medical device labeling, reach out to Morningside below. Our team has in-depth industry knowledge of country-specific regulations, global markets, and the entire life sciences commercial supply chain.