Putting Translation Central to the MDR Shift

When it was announced the Medical Device Directive (MDD) would be replaced by the Medical Device Regulation (MDR) several years ago, it triggered an enormous task for healthcare providers and manufacturers. Instructions for use (IFUs) remain vital to improving hygiene and healthcare safety and standards around the world. With the switch to the MDR predicted to affect more than 500,000 types of medical and in vitro diagnostic devices available on the EU market, the task was set to have a colossal impact on the sector.

Hundreds of thousands of existing IFUs would not only need to be updated in the many languages they’re already written in, but they would also have to be made available and accessible in additional languages, as the MDR would widen to include all 27 EU Member States.

However, earlier this year, the European Commission postponed the deadline to update IFUs to the new regulations by 12 months, to 26 May 2021, to mitigate against the situation presented by the COVID-19 pandemic. Though this allowed affected companies more time to prepare, time has accelerated, and it is now a mere matter of months before the MDR comes into play once and for all.

The regulations are directly enforceable in each Member State, meaning there is little room for discrepancies in their interpretation. As such, those updating their IFUs must take all necessary steps to ensure their information is technically and medically precise. To achieve this, medical translation specialists teamed with the latest translation technology can ensure accuracy and consistency across different language versions, while making sure that future updates can also be made with ease. The Change from MDD to MDR The MDD, which came into law in 1992, was drafted before the surge in technology and the internet, both of which have enabled massive changes in the industry. For example, many consumers now use apps to monitor their own health, and there is increasing demand for software applications, such as the ability for doctors to view MRI scans from their smartphones.

We also have a higher global population and the average age of death has increased dramatically. These social, economic and technological advances have encouraged officials to create a new set of guidance – governable by law – to improve transparency, safety and security in these areas.

The MDR, which will be four times longer than the MDD, will provide more effective, consistent guidance to all 27 EU Member States, enabling them to increase quality control and hygiene across a huge range of devices. It will apply to everything from plasters, scalpels and pacemakers, to blood sugar monitoring systems, pregnancy tests and HIV blood tests.

Specifically, the MDR will cover:

1. Coloured, non-corrective contact lenses or other items that are applied directly to the eye. 2. Products that must be inserted into the human body through surgical means to modify anatomy or fixate body parts. 3. Substances, or items to be used for facial or nasal cosmetic purposes. For example, dermal fillers. 4. Equipment intended to aid in the reduction of adipose tissue. This equipment includes tools used for liposuction or lipolysis. 5. High-intensity electromagnetic radiation-emitting equipment used on human skin, including tattoo or hair removal, skin resurfacing, or other skin treatment. 6. Equipment used to penetrate the skull in order to modify neuronal activity using electrical currents or electromagnetic fields (transcranial magnetic stimulation).

Although the changes are now set to take effect mid-2021 – and even later for in vitro devices – companies should begin to start action, updating and translating their IFUs, now. Translation Memory Though the MDR will primarily affect the 27 EU Member States – excluding the UK – manufacturers all over the world will have to adapt to the regulation in coming years, whether that’s in the recertification of existing products or ensuring their practices are in line with the guidance within the MDR. Issues of importance include ensuring IFUs for technical guidance, product labelling and clinical data are available and accessible in all necessary languages, meaning many manufacturers and other levels of the supply chain will come to rely on translation services in the near future.

However, those working in already highly regulated industries who haven’t used translation before may worry that a translator either won’t understand their terminology, or that suitable translations into other languages aren’t available and therefore won’t make sense to the end user.

It is certainly key to ensure that translations are only completed by medical specialists, however technology also has a part to play: certain translation technologies have the facility to incorporate bespoke ‘translation memories’ of a company’s most frequently used terminology and language, built by specialist medical translators to ensure that complex phrases and words are translated accurately and consistently in multiple different languages. Combining the medical knowledge of the translators with this smart technology ensures that the finalised content is fit for market, no matter which country in the world it is being used in, whilst also providing efficiencies in the process. This approach solves major challenges when it comes to approvals, time saving and cost benefits – all of which will be front and centre of mind for manufacturers worried about how much time remains to complete the switch from MDD to MDR.

Translation memory software is designed to make the process of translation smarter, more automated and more precise. It stores and remembers words, phrases and even

entire sections of text in company-specific, secure databases.

When an IFU is updated with new information, if the translation of previous material is in the translation memory (which is specific to the company producing the IFU), it issues a prompt to the translator that there is bespoke information available in their language, which can be reused to speed up the process. It means the translator needs to focus solely on the new content being translated, and that the client doesn’t have to pay for applying the same translation.

If parts of the previous IFU have been translated in a similar but not identical way before – such as will be the case for many MDD to MDR transitions – the translation memory will highlight this to the translator too, with the necessary changes marked, making huge efficiencies compared to translating from scratch. In one case of doing so, in a 46,451-word project, we actually only needed to translate 18,993 words, with the remainder being reused via the translation memory.

Clients are delivered first-rate terminology and high-quality translations which are consistent across the board, with specialist linguists controlling the process to ensure that the technology is correctly retrieving the appropriate translations. Because, ultimately, technology on its own is not a powerful enough force. A great deal of input from both a translator and account manager is still needed in order to ensure a translation project runs smoothly, and that the desired level of quality required by the MDR is achieved. Terminology Management Though updating IFUs will be the priority as the MDR comes into play, companies must also be active in communicating they have taken the steps to do so. Whether that’s through adding new content to a website, circulating employee communications, or sharing company news on social media, consistent messaging and terminology is needed across all platforms and it will be essential that any language that’s updated as part of the MDR transition is also updated on your other communication channels.

For example, it wouldn’t be savvy to translate the name of a product into different languages from around the world, if the whole company and its users or customers know it by its hero-language name. Without careful management and close communication between you and your translation provider, such inconsistencies can easily creep in.

It’s essential for translators to work with clients to develop a comprehensive understanding of the terminology a business prefers to use across its product names, corporate language and for terms that might have multiple options within a local language. Consider the relatively simple examples in English of referring to a ‘fracture’ or a ‘break’; these terms describe similar concepts, but it’s vital that the correct terminology is used consistently throughout your documentation. Imagine these decisions across multiple languages and you begin to see the importance of terminology management. Ensuring accuracy and consistency across these terms and their translations maintains the brand’s values, upholds professional reputations and can more easily drive sales, whether you’re translating a website or undertaking technical translations such as those we’ll see during the switch to MDR.

‘Termbases’ are specialist software applications designed to develop glossaries, and which can give more detailed context or definition to the words used within a text. Sometimes based on a client’s own glossary of terms where available, they also highlight forbidden terms, to ensure that they’re never able to sneak into a company’s marketing material or technical documents. Available via the cloud, all relevant parties contributing to a translation project have access to the glossary to ensure that terms are pre-approved by client stakeholders.

Because termbases can also be integrated with translation memory systems, the appropriate term for a specific language is suggested automatically to the translator, to eliminate any ambiguity in terminology usage that may arise. When used in partnership with translation memories, the outcome is even fewer words requiring translation, resulting in more significant time savings and cost reductions.

On completion of the project, automated QA tests can be run to ensure that the translator has followed the termbase and that the terminology used in the document is as agreed.

The result is consistency across all communications, a reduction in possible errors which allow for faster and more accurate proofreading, and the ability to manage terminology and translation from one centralised location.

The introduction of the MDR will lead to a greater level of scrutiny of the technical documentation used within the medical industry and will have a knock-on effect throughout the supply chain. However, by using translation technology in a variety of capacities, manufacturers can ease the burden of the transition while time continues to tick away. By putting faith in a translation services provider which combines specialist medical linguists with technology to create translation memories and glossaries that are completely in tune with the need for stringency, accuracy and compliance, this burden-like era for the medical sector will be eased, enabling businesses to get ahead of the changes, so they can focus on strengthening relationships rather than regulations.

Alan White

Alan White has worked in the translation/localisation industry for over 20 years; as a translator, an account manager and in business development. Alan currently heads up the business development team at The Translation People, working with a variety of clients from different industries, advising on best practice when communicating with an international audience. As a fluent French and Spanish speaker, Alan is passionate about languages and their use in breaking down communication barriers, both in a business context and beyond. He is committed to providing companies with customised solutions that meet their requirements and allow translation budgets to be maximised, in particular those that combine the best that translation technology can offer with high-quality linguistic input from specialist translators.