Regulatory & Marketplace
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 16 INTERNATIONAL PHARMACEUTICAL INDUSTRY
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. 2. 3. 4.
5.
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Coloured, non-corrective contact lenses or other items that are applied directly to the eye. Products that must be inserted into the human body through surgical means to modify anatomy or fixate body parts. Substances, or items to be used for facial or nasal cosmetic purposes. For example, dermal fillers. Equipment intended to aid in the reduction of adipose tissue. This equipment includes tools used for liposuction or lipolysis. High-intensity electromagnetic radiation-emitting equipment used on human skin, including tattoo or hair removal, skin resurfacing, or other skin treatment. 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 Winter 2020 Volume 12 Issue 4
