The MDR imposes strict requirements on medical devices and their documentation, both in the original language and in translation. By entrusting their translations to a certified translation agency specializing in medical technology, manufacturers of medical devices can rest assured that all their documentation will conform to the MDR. We explain how it works, and what you should look out for when choosing your language service provider.
The health and safety of patients and medical professionals matters more than anything else. So it’s no surprise that medical devices are subject to ultra-strict regulations. In May 2021 the new European Union Medical Device Regulation (2017/745), MDR for short, will take full effect following a transition period which has been affected by the COVID-19 pandemic. From then on, manufacturers will have meet more stringent requirements before their medical devices can be launched onto the EU market, both in terms of the products themselves and their documentation.
High-quality products are safe products, and that also applies to their documentation in the original language and in translation. The MDR requires manufacturers of medical devices to provide an accurate translation of safety documentation before they can sell their products in the EU. As well as conventional instructions for use (IFUs), user manuals, product data sheets and labels, the requirements cover clinical reports and study results. Depending on where manufacturers plan to market their devices, they may need to translate the relevant documentation into up to 24 languages (i.e. all official EU languages).
The requirements for translations are strict, as correct, easy-to-understand texts are the only way to ensure that medical devices can be used safely by patients and medical professionals. Medical technology providers are reliant on a professional translation service provider that knows and complies with the requirements of the sector. And the good news is that once they’ve found one, they can rest assured that from then on all their translations will be MDR-compliant.
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The ISO 13485 standard imposes even stricter requirements on translations than the MDR. So if a translation agency is ISO 13485 certified, the translations they produce are guaranteed to be MDR-compliant. |
There are various criteria that language service providers need to meet in order to produce high-quality language services, and they have a direct impact on the standard of specialist medical translations. The questions to ask are:
Evidence of certifications, above all ISO 13485 and ISO 17100, will also help you find the right translation agency. Certifications give you the peace of mind that the agency’s workflows and services meet a required standard, and that their working practices are regularly audited.
One key factor in whether agencies can offer high-quality translations in all languages is translators who specialize in medical technology. Although there’s a wide range of documents that need to be translated, they all require in-depth medical and technical expertise, and the linguistic challenge is to cater for various target audiences with their specific terminology and to cover a wide range of areas. For instance, instructions for medical professionals need to be accurate, use the correct terminology and reflect the state of the art in the respective specialist area. By contrast, when supplying information for patients – i.e. people without medical knowledge – the top priority is to produce texts that are clear and easy to understand.
It’s also important that the translation agency always uses the same translators. Core translators will be familiar with each client’s products, and they’ll know best which specific terminology and wording to use, which will guarantee consistent, high-quality texts.
Another factor in high-quality translations is the use of state-of-the-art technology and tools. All agencies should use CAT tools, translation memories and term bases, as they’re essential for producing consistent, accurate medical translations. Plus, in the long-term they’ll significantly reduce how much you pay for translations. So make sure the agency has smooth, efficient workflows in place and can adapt to suit your needs. If they talk about using copy and paste, for example, the alarm bells should be ringing in your head – there’s no place for error-prone methods like that in the 21st century!
You should look carefully at agencies’ risk management processes when choosing where to send your IFUs, labels, manuals and data sheets for translation. Language service providers should conduct a risk assessment in relation to the quality of the services they provide and patient safety, and if necessary they should take proactive steps and review their effectiveness.
The same applies to feedback and complaints. All feedback, whether positive or negative, should be documented in order for an agency to build on its strengths and eliminate its weaknesses. Take note of how they implement feedback and how much time they invest in analysing, resolving, and above all preventing errors. In the long term, this is the best way to ensure high-quality translations, and ultimately patient safety.
One factor that is often underestimated in high-quality translations is communication between clients and agencies. So clarify your expectations: you’ll be happier with the results if you tell the agency what you need as precisely, clearly and frequently as possible.
If you need MDR-compliant translations, let’s talk about how we can help!
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