Ana Sofia Correia
Best practices when translating your medical device documentation
Updated: Jan 8
Concise and jargon-free text, symbols, easy-to-understand images and graphics can help you access foreign markets while reducing translation and quality assurance costs. In this article, I share five best practices you should keep in mind when translating your medical device documentation.
Marketing your medical devices outside the country where they were developed requires careful translation of all instructions and specifications. There are multiple types of texts that relate to the medical devices industry:
instructions for use (IFUs);
operating and installation guides;
package inserts and labels;
apps and user interface (UI);
regulatory compliance documents;
Here’s what you should do when planning the translation of your medical device documentation:
1. Define your target audience
The target audience for your product may vary from healthcare professionals to maintenance staff to patients. All of them have different backgrounds and educational levels, so the written document will vary in level of complexity and technical or scientific language usage.
If you are targeting patients, always keep simplicity in mind. Expressions used among healthcare professionals cannot be used in a text that is intended for patients.
2. Use clear and consistent language
According to Annex II of the Medical Device Regulation (MDR) (EU) 2017/745, manufacturers must include in the technical documentation all the languages accepted in the Member States. Without this, the medical device won't get the CE marking (which means that "products sold in the EEA [European Economic Area] have been assessed to meet high safety, health, and environmental protection requirements").
Creating clear and consistent instructions is a key factor in streamlining this process.
This means avoiding acronyms and abbreviations, which vary from language to language, as well as idioms and unnecessarily complicated terminology, as they often don't translate well across languages.
Plus, besides making the translation process more manageable, plain language will help ensure that the translated documents comply with the MDR.
3. Reuse approved content
By avoiding unnecessary changes in the source text and applying approved glossaries and style guides, you will get long-term benefits, such as quality assurance, consistency, and savings.
Your translator should use a translation memory and terminology database to handle your updates.
4. Use standard labelling
The labels on your medical device should be written and translated as clearly and concisely as possible.
Use well-known symbols that are easy to read and understand at first glance in any language. For example, the international symbols found in ISO 15223, such as "caution," "manufacturer," "keep dry," "biological risk," etc.
Including symbols in the device labelling decreases the danger of adding improperly translated text. Plus, symbols usually take up less room than text.
5. Work with a human translator (or at least, post-MT editor)
While machine translation has its place (and technical documentation may seem the perfect candidate for automatic translation), you can't afford mistakes when it comes to healthcare documentation – even if you are dealing with a tight turnaround.
Specialized medical translators serve as protection against errors, whether they are translating or editing a machine translation output. They should be native of the target language and have experience related to your specific medical device to guarantee error-free, easy-to-understand translations.
Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.