Medical devices are subject to high, independently regulated government standards. This is also the case when it comes to labelling these devices. Medical device labels give manufacturers and users essential information about any critical risks and benefits, as well as clear instructions for safe use. These documents are essential to health and safety, and as such, medical device labelling is also a strictly regulated process.
What is medical device labelling?
Labelling comes in a wide range of document formats, including brochures, leaflets, user manuals and videos, as well as device packaging. This can be presented as written, printed or graphic content on or in the device or packaging. According to ISO 13485, it includes all symbols, warnings, information displayed on a user interface (UI) and any documentation relating to the product.
Basically, labelling is any document containing explanatory information meant to inform the end user. With such a wide variety of formats conveying critical information, translating medical device labelling is a complicated process with much at stake.
Read on for our 5 top tips when it comes to translating medical device labelling for global markets in multiple languages.
1. Use the right language
Medical device labels must be understood by everyone. This means the content needs to be well organised, easy to read and written in plain, simple language. Important safety information should also be highlighted.
Medical texts often contain a lot of technical jargon and abbreviations and using these in labelling will lead to confusion and misinterpretation. But by following the above principles, you can make sure that your target audience will be able to understand the content easily.
2. Meet regulatory requirements
Most countries and regions have their own medical device regulations for handling medical device labelling. These are highly regulated, which means that when entering a new market, any labelling content will be closely scrutinised. As such, these documents and their medical translations must be as accurate as possible.
They must also meet all regulatory requirements, and so any medical device content must be provided in the user or patient’s native language. Under the EU MDR, the 27 member states of the EU can require medical device labelling to be written in the national languages of each state.
This means that most countries in the EU will require all medical device material to be translated into their official language. In some cases like Switzerland, this will mean translating all content into several languages. When expanding into a new market, it’s important to check which languages you will need to supply your documents in.
3. The importance of visuals
If you need to translate your documents into several languages, formatting could become an issue. However, you can instead use simple graphics, diagrams, symbols, and icons that are recognised worldwide to help break down any language barriers.
If there are internationally standardised symbols you can use, then make sure to do so. This will allow you to highlight key information in a way that is easy for the target audience to understand.
When using graphics or diagrams, they must:
- Have dark lines so they are easy to read
- Be the right size—bigger is usually better
- Use arrows or circling to highlight key details
4. Use accurate translations
When working within the medical device industry, inaccurate translations can lead to a delayed market entry or a rejected application. But even if the mistakes go unnoticed and your documents pass the review, you would still be liable for any problems or accidents they cause.
Intertranslations holds several quality and data safety certifications awarded by international organizations which distinguish us in the global market, such as ISO 17100: 2015 standard.
5. Use expert translators
With human lives at stake, translation requirements are strict when it comes to this type of translation. This means that any medical device translations should always be carried out by specialist translators with expertise in the relevant medical fields. An in-depth understanding of both the medical terminology and regulatory requirements of your target country is essential for an accurate translation. Choosing a specialist will help make sure all the right boxes are ticked.
Working with a translation agency will give you access to a whole network of translators specialising in your area. When choosing who to work with, make sure to look out for an ISO certified translation agency like Intertranslations. This means that we have strict processes in place to ensure quality and accuracy, giving you the best chances of receiving the highest quality translations.
At Intertranslations, we work alongside a team of medical translation specialists using advanced translation technologies to ensure accuracy and consistency. This gives you top quality service with the best turnaround times and the lowest prices. Get in touch to learn more about our internal processes and the different translation services we offer.
