6 Considerations for Translating and Localizing Medical Device Labeling
If you are a manufacturer or distributor of medical devices, chances are you are looking to market and distribute your products across borders. In this highly regulated industry, compliance with stringent policies and latest guidelines is paramount. And it is not just about the effectiveness and safety of your products. There are also very strict rules when it comes to medical device labeling.
Medical device labels are not just the stickers found on packaging. They cover everything from product descriptions and marketing materials to documentation and instructions for use (IFU).
This makes translating and localizing medical device labeling complex. Here are important things to consider when planning to export medical devices:
Regulation of Medical Devices
When you bring in a medical device to a new market, expect all labeling to be scrutinized for compliance with local regulations. This is understandable as it can risk patient safety and health. A wrongly translated sentence or poorly worded instruction can have adverse effects. It can damage your product or, worse, cause harm to a user.
To complicate matters, every region or country has its own specific laws and regulations when it comes to medical device labeling. Most countries require that all materials should be translated into their official language or, in other cases, several languages.
And these regulations change constantly. For example, when the European Union introduced its Medical Device Regulation (MDR) in 2017, it included tighter rules on the level and accuracy of device labels; thus, manufacturers had to update all labeling.
Importance of Harmonization
With all the confusion, complexity, and cost of varying regulations, stakeholders from governments, the industry, and the public called for harmonization. And so, the Global Harmonization Task Force (GHTF) was set up in 1993 to provide guidance and common standards for the regulation of medical devices, including labels.
The GHTF gave specific recommendations on ensuring that labels are easy to read, understand, and follow. It also advised that national language requirements be kept to a minimum. It similarly called for minimizing country-specific requirements for labeling text, content, and format.
While not legally binding, it encouraged cooperation and convergence among regions and countries. This has since been endorsed by the International Medical Device Regulators Forum (IMDRF), which replaced the GHTF in 2011.
Creating Readable, Understandable Documents
The GHTF recommended that labeling be made available in an understandable language– i.e. logically organized, highly readable and accessible, supported by simple graphics and diagrams, highlighted safety information, and proper testing to ensure it can be understood by the target audience.
Some practical ways to do these:
- Use simple words. Create content with middle school-level English, using simpler words (for example, “use” instead of “utilize”). Rewrite technical jargon into plain language. Avoid acronyms and abbreviations.
- Write short sentences. Sentences should be short and clear, breaking long ones apart. That means dropping dependent clauses. Most health agencies recommend writing for an audience of no higher than sixth grade reading level.
- Eliminate words that will not translate well. These include idioms, slang, and cultural references.
- Be consistent. Use the same terms and words throughout your document. And use consistent formatting, typeface, and location for headings to organize information.
Standardized Symbols and Icons
Using symbols and icons can further simplify labeling. Common examples include symbols for caution, fragile, and biological risk levels. These can also save space and reduce the amount of text that needs to be translated. However, be careful and direct with the use of symbols, as some could cause confusion.
Some things to keep in mind:
- Stick to internationally standardized symbols. Refer to ISO 15223-1:2016, which gives a standard list used for a wide array of medical devices in many countries.
- Eliminate symbols that are not universally understood. Some standard symbols may still not be common enough for everyone. So, either drop these symbols or include a short description after.
- Test, test, test. The best way to make sure your symbols and icons are properly understood is to pre-test them before rollout.
Accurate Translations + Patient Safety
There’s a lot of risks with inaccurate translations for medical device labeling. For instance, your market entry can be delayed, or application unapproved. Even if you pass the initial review, you’re still liable (fined or sued) if a mishap or accident occurs.
Aside from the legal ramifications of erroneous translations– the improper use of your medical device due to confusing language can cause physical harm or even death. Whether it is a medical practitioner or a patient, you do not want to take that risk.
The possibility of litigation coupled with reputation damage is motivating enough to get the translation correct. Therefore, it’s important to incorporate localization best practices into labeling from the outset.
ISO-Certified Language Services Providers
Of course, this is easier said than done. Using only human translators is not scalable. Relying solely on machine translation engines will not yet work efficiently – rather, it will not provide the required level of accuracy. And there are so many things to consider: the sheer volume of content to translate, the varying regulatory requirements, and the differences in medical terminology across the globe.
The best approach is to work with a language services provider (LSP). But not just any generic LSP will suffice. Consider these factors in your selection process:
- Industry know-how. As this is a highly regulated field, your LSP should know the ins and outs of regulatory requirements for various types of content for med device, clinical trials, etc.
- Life sciences background. Your LSP should have a scalable/vast network of specialized translators with backgrounds in life sciences who understand the medical terminology associated with the product.
- Linguistic expertise. Localized content is not just about literal translations. Your LSP should be excellent in understanding the cultural context and linguistic nuances.
- Technology-driven. Using automation and machine translation with human translators will help speed up the work, and your LSP should have experts that utilize translation technology and language assets, such as translation memories (TMs). Technology and language assets improve consistency and quality while reducing costs.
- ISO certification. Being ISO certified in quality management and translation services is a must, but if your LSP is also certified in quality management systems for medical devices (ISO 13485:2016), you’ll have additional confidence you’re working with the right partner.
With so much at stake in translating and localizing medical device labels, simply being “good enough” will not cut it. Complete and compliant work is mandatory!
Partner with Welocalize Life Sciences
With 20+ year of experience in the field, Welocalize Life Sciences specializes in language solutions for the dynamic life sciences industry. We provide clinical and medical translations at the highest quality standards that meet regulatory compliance.
Our enterprise-wide solutions are certified and compliant with ISO 9001:2015, ISO 13485:2016, and ISO 17100:2015. We can help you with translating and localizing your medical device labeling that will meet the strictest regulation and the highest quality standards.
Contact us to find out more.