In the medical industry, you can’t just produce a label with some warnings and information and then stick it on a medical product. As anyone who’s familiar with labelling knows, there are strict regulatory requirements that have to be met across the board. For patients and users of medical products, safety is the number one priority – but how can labelling translations ensure maximum safety, and what can translation agencies do to help?
The medical industry is subject to very strict regulatory requirements and standards (in Europe these include the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR), which came into force in 2022), where the overriding priority is to ensure maximum safety for patients and users. The MDR regards all accompanying documentation, such as instructions for use, labels, imprints, flyers and apps etc., as part of a medical product, which means there are stringent requirements for the label and the translations. If these requirements aren’t met, the product can’t be sold on the market. Each bit of content is a potential safety risk, and this needs to be minimized.
When translating texts for medical products, there’s a wide range of potential types, from small labels with restricted space to comprehensive technical documentation.
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Top tip |
| Did you know that you can use pixel-based length limits in translations as well as character limits? This can make it easy to translate labels where space is limited. |
A translation agency that specializes in labelling translations can handle lots of the work for you, and will be on hand to offer advice whenever you need it. But if you’re hoping for a straightforward process – send the texts and get high-quality, MDR-compliant translations back – then there are a few things to bear in mind.
As well as ISO 9001 and ISO 17100, in medical technology ISO 13485 is the main standard. If your translation agency is ISO 13485 certified, you can rest assured that they’re specialists in medical technology. Getting certifications is expensive and time-consuming, and it shows more than just an ability to “work in accordance” with a standard for a short period of time – it’s evidence that quality management is part of a company’s DNA. Translation agencies with ISO 13485 certification are audited every year by an accredited body, which means you don’t have to carry out your own supplier audit.
And ISO 13485 certification also ensures that all processes are rigorously documented – processes which define how the agency acts both in everyday situations and exceptional circumstances. Whether it’s in the preparatory stage, the production stage (the translation itself) or the post-production stage (quality assurance checks, evaluation, feedback), everything follows a set standard. So in the event of damage, everything is fully transparent.
Translations of medical products must be clear, precise, and of course correct. The top priority is that the user must understand how to use the product. Flowery language, and any phrasing which might be ambiguous, is completely the wrong approach for labels. All translators who specialize in medical translations know that, and if you provide a glossary with your terminology, you can expect a translation agency that works with these experienced medical translators to deliver clear, precise and accurate translations of your labels. Ideally, the agency will always use the same translators and reviewers for your projects, which means that over time they will become experts in your products. And there’s another benefit of using core translators: privacy. Agencies have strict written agreements in place with their translators to ensure their clients’ data remain confidential, and the fewer people are involved with the translation, the better.
Terminology can be a major challenge when translating labelling. Labelling departments often only get involved with terminology issues late on, even though it’s something they should be thinking about from the start. Consistent terminology is crucial to ensure labels are understood correctly and medical products are used safely, and if three different terms are used for the same thing, you can’t guarantee that the reader/user will know what’s meant. So we strongly recommend getting to grips with terminology management. You’re not alone: your translation agency can help you create, structure, publish and maintain an effective term base.
Translation agencies offer a range of service levels. To ensure maximum safety, for labelling translations we recommend the “ISO 17100 translation with review” workflow. That means once the translation is complete, another specialist translator will review it by comparing it against the source text and ensuring everything has been translated correctly. But if you’re getting medical documentation translated, another option is machine translation combined with full post-editing and review. Using Pro versions of machine translation engines ensures your data are secure, so talk to your translation agency to find out which engines it uses and how they handle data privacy. (Top tip: check whether the agency also has ISO 18587 certification, which is the standard for post-editing machine translations).
Data security shouldn’t be overlooked, as the contents of labels are sensitive and confidential. And because the translation is usually produced before the product is launched, it’s even more important that nothing leaks. So it’s a good idea to find a translation partner that has high IT standards, including systems which enable encrypted data transfer.
In-country reviews, i.e. reviewing the content of the translations, can give you higher-quality results and more security. But they can also often cause chaos: imagine 25-40 of your colleagues in other countries, who know all about your products but may have nothing to do with writing texts or producing translations, working on the texts and editing them. When they’re done, the translation will have to be sent back to the agency. So we recommend talking to your agency to establish a workflow that’s right for you. Especially if core translators are used and you have a term base, our experience is that in-country reviews are unnecessary.
Experience in medical technology is one thing that makes specialist translation agencies stand out, but agility and technical expertise are just as important. Every business works differently and has different software and processes. If your translation partner has the flexibility and agility to handle all your needs in the labelling process, this will be a big help and make your life a lot easier.
Main image: © Rene Knabl