he market for medical devices is worth around $90 billion a year in the European Union alone. That’s big business.
But if you are planning on marketing medical devices in the EU – or anywhere in the world – as a manufacturer or distributor, you need to comply with local and international regulations relating to device labels.
This makes translating medical device labelling a serious concern for businesses worldwide. Because labels aren’t just something you slap on the outside of the packaging.
As an industry professional, you know that:
- Medical device labelling can include everything from marketing materials to critical user instructions.
- Regulations vary dramatically by region – and they can change over time.
For example, the European Union’s medical device label regulations update of 2017 led to a lot of activity in the field of medical translation. Manufacturers scrambled to update their labelling.
On top of this, the COVID-19 crisis has only drawn further attention to the importance of medical professionals being able to work collaboratively across borders. Clear translations of all vital documentation are key to this.
Here are some tips to ensure that the process of localising your medical device labelling is smooth and easy:
What is a medical device label?
A layman might imagine a medical device label to be simply information on a piece of medical machinery.
To the industry professional though, a medical device label might include – according to the US Food and Drug Administration’s definition – “any information associated with a device targeted to the patient or lay caregiver.”
This means a medical device label could actually be:
- Marketing materials like leaflets and brochures
- Product packaging
- Product descriptions
- User manuals (commonly called IFU – Instructions For Use)
- Safety instructions
- Accompanying software
- Any document which explains how a medical machine works or how it is used
You might also need to translate documents like patent applications, applications for regulatory approval, patient information sheets, clinical trial forms and more.
It’s also important to note that what constitutes a “medical device” is actually a very broad field. We aren’t just talking about ventilators, MRI machines or other large pieces of equipment here.
A medical device can be anything from a pacemaker to syringes to stethoscopes to gloves and other PPE (Personal Protective Equipment).
Medical device regulations by region
Every region or country will have its own specific laws and regulations when it comes to medical device labelling.
Two of the most important regions to consider are the US and the EU. This is because the vast majority of the world’s medical device manufacturers are based in one of these regions. The US, in particular, has worked long and hard to corner as much of the market as possible.
The US Food and Drug Administration
The FDA has a series of categories of medical devices. Class I includes things like latex gloves and has relatively mild regulations. Class IV includes high-tech life support equipment and the like and has significantly more precise regulations.
The European Union has a similar categorisation of devices based on the level of risk they pose to patients.
There are also various directives which govern specific types of device. These include those for Active Implantable Medical Devices (AIMDD), general Medical Devices (MDD) and In-Vitro Medical Devices (IVDR).
Its general MDR (Medical Device Regulations) were updated back in 2017. Changes to IVDR come into effect in 2022.
The importance of language
One of the major specifications of regional and international medical device regulations will always be the languages they need to be available in.
For example, the EU requires that any of its current 27 member states can require medical device labelling to be written in their national languages. This often means that manufacturers need to ensure their labelling and other materials are available in every national language of the EU – though the different categories of devices can affect this.
This is certainly the case in order to achieve the highly desirable CE logo. This is the certification marking which indicates a product sold in the European Economic Area – the EEA – has been officially assessed as being of high quality.
Outside of the EU, it’s likely that a country will require medical device labelling to be in their national language as well as possibly other official languages or those in daily use too.
However, there are exceptions. If the equipment is only going to be used by professionals, the UK, Ireland, Malta, Poland, Cyprus and Luxembourg are among the nations which may allow you to market devices with labelling only in English.
The International Medical Device Regulators Forum
The Global Harmonization Task Force was set up in 1993 to try to institute some kind of overall guidance for regions, countries and regulators aiming to create individual regulations for medical device labels.
The guidance the GHTF produced wasn’t legally binding. But it was a solid touchstone for manufacturers, healthcare providers and translation agencies working in the field of medical devices.
The GHTF was replaced by the International Medical Device Regulators Forum in 2011. Keeping up-to-date with their findings is well worthwhile for anyone with a vested interest in the field.
Another source of professional expertise will be your Language Service Provider (LSP). Because using a specialist translation agency is an absolute must when it comes to medical device translation, you can call on them if you have questions about translating your device labelling.
General strategies for localisation
Before being replaced by the International Medical Device Regulators Forum, the GHTF produced a final report which made certain recommendations for international medical device labelling. These chimed with the recommendation and regulations produced by organisations such as the FDA.
They recommended that labelling, especially that designed for patients and non-professionals should be:
- Available in an understandable language
- Logically organised
- Highly readable and accessible
- Supported by simple graphics and diagrams
- Good at highlighting safety information
- Properly tested to ensure it can be understood by the target audience
Common medical device translation mistakes
There are a couple of very common mistakes made when translating medical devices:
1) Amending existing labelling
In the US, new medical devices need to be compared to an existing device (called a predicate device) in order to be approved for general use. Problems arise when manufacturers assume that they can use the existing wording on the predicate device labelling.
Though the US is a special case, similar things happen with IFU – user instructions – and product information of all kinds around the world.
It is never a good idea to re-use existing labelling. The quality of the translation you get will always be directly related to the accuracy and quality of the original labelling.
2) The question of address
Depending on the region you are selling in, you are likely to need to include multiple addresses on device labels.
For instance, the EU’s new regulations insist that both the name and address of the manufacturer and their authorised representative are included. The FDA requires the addresses of the manufacturer, distributor and packer. Other regions will require other specific addresses.
Again, working with an LSP with proven expertise in the field of medical translation will stand you in the best stead. For example, Asian Absolute only ever uses former or practising medical professionals to translate into their native language in all medical device translation projects. This ensures they know what information a label needs to contain and can be a source of invaluable checks.
Tips on medical device label translation
Meeting regional and international regulations is, of course, a requirement before you can sell medical devices.
But even if this wasn’t a necessity, if you want your customers and patients to get the best out of using your device, providing clear instructions in a language they can understand is still vital.
You can achieve this by:
1) Starting at the beginning
As with all localisation efforts, planning for the fact that your designs will be multilingual is much easier if you do it right from the start.
Writing your labelling focussed on one language and then tacking on versions in other languages at the other end is much more difficult, timely and costly than simply building localisation best practices into your labels from the very start.
This will mean following the practices listed below from the beginning.
2) Keeping your language simple
The simpler and more concise you can make your labels, the more accurate and effective the localised versions will be.
Of course, the field of medicine and healthcare includes a huge range of complex terminology. But you should always bear in mind your target audience. In general, but especially if your target audience is non-professional, always aim to be straightforward and precise.
It’s also important to note that even this terminology may not be truly international – there may be local equivalents.
In the language and visuals you use on your labels, always try to avoid things like:
- Cultural references
- Jargon and complex terminology (where possible)
3) Using plenty of graphics and diagrams
The old adage that a picture is worth a thousand words is doubly true when it comes to product instructions. You should almost always aim to include simple, easy-to-read instruction diagrams in your product labelling.
Some general tips for graphics and diagrams include making sure that they:
- Are of the appropriate size (bigger is usually better)
- Use dark lines, as these are easier to read
- Use arrows or circling to highlight important details
Just be sure that you haven’t used any culturally-specific images or ideas in your graphics. Not every hand gesture is international, for example.
4) Incorporating videos and animations
If a picture is worth a thousand words, a video can be worth a whole lot more. Multimedia labelling is becoming increasingly popular because of this as well as its many other advantages.
Localising these materials requires special attention (many of the techniques are the same used when localising e-learning materials). But the results in terms clarity and engagement are worth the effort.
5) Sticking with international symbols
Some symbols and icons have become internationally standardised. Try to stick with these to improve the localisation process.
Some of the most common international standard symbols include those for:
- Fragile, handle with care
- Keep dry
- Biological risk
6) Including electronic documentation
Including electronic versions of important documentation allows you to keep comparably expensive hard copies to minimum sizes.
For example, regulation-compliant IFU in all of the EU’s current 24 official languages might run into hundreds or even thousands of pages. That’s a lot most cost-effective as a digital file than it is on paper. It also takes up a lot less space.
7) Using a specialist human translator
Custom Machine Translation engines which have been specifically trained on medical texts have their place. But when it comes to medical device label localisation, you should only ever use a human translator who is intimately familiar with the field.
For instance, all of Asian Absolute’s medical device translators are native-speaking experts with Masters degrees and/or doctorates as well as likely extensive experience in the medical field.
Using anyone other than qualified and highly experienced professionals is a recipe for problems later down the line. These could range from negative patient outcomes to potentially expensive lawsuits caused by inaccurate or imprecise translation.
8) Testing, testing and testing again
After the localisation process is complete, you should always test your finished label extensively on members of your target audience to ensure that your labelling is clear, correct and easy to understand.
The localisation process includes adapting every single aspect of your labelling for an audience which hails from a different country or culture. This includes everything from language to images and graphics to local formatting preferences, colour choice and more besides.
Even if you know your LSP is correctly using a specialist medical translator who is localising into their native language, it is still worth making sure that they or you test the results you get on representatives from your actual audience.
Medical device regulations are always evolving
Once you’ve finished localising your labels, regularly reviewing them for quality and compliance is a sensible measure.
As the recent changes to the EU’s Medical Device Regulations show, the rules regarding what makes for best practice when it comes to medical device labels and their translations aren’t static.
This makes it more important than ever to work with an expert in the field who stays on top of these sorts of developments. That’s why you should always check for ISO certification when choosing your Language Service Provider.
This way, you will have expert advice on hand when it comes to translating medical device labelling for any market in the world.
Do you need to know more about medical device labelling localisation?
Asian Absolute’s specialist medical translators are ready to help. As former or practising healthcare professionals, they’re ideally placed to do so.
Get in touch with us to find out more at any time.