Wording and formulation are becoming increasingly relevant in the life sciences and medical devices.
2020, the year of the pandemic, is leaving its mark. Even the German medical technology sector, which is used to success and which, together with the chemical-pharmaceutical industry, is one of the three largest and fastest-growing sectors in Germany, did not escape entirely unscathed and, despite steadily rising demand, recorded a decline in sales again for the first time, at least in certain areas. The main reasons for this are said to be the massive losses worldwide due to the postponement of operations that were not urgently needed, the restrictions on customer contacts for the sales force and the decline in prescriptions due to the lack of visits to doctors. The industry, which is known to be extremely innovative, is making use of the experience gained during the pandemic and is increasingly focusing on digitalisation in medicine. Health apps, telemedicine, artificial intelligence and robotics show that the coronavirus crisis is giving electronic and digital concepts a boost.
Fast-paced, innovative, high investment in research and development (R&D)
The distinctive innovative nature of the industry is reflected in a particularly high rate of investment in research and development (R&D). According to MedTech Europe, the average R&D ratio in medical technology worldwide is around 8% (expenditure as a percentage of sales). The fundamentally positive trend should continue, as the technological advancement of the healthcare industry grows from year to year. Drivers are the personalisation of treatments, the trend towards outpatient care and increased care at home. Networked medical devices, AI diagnostics and digital platforms for patient information systems are making medical care more flexible and independent in terms of location. A slight slowdown in the growth rate, which was around 5% in previous years, is to be expected. In addition to the ongoing discussion about Brexit, the new medical device regulations also play a major role here.
New MDR – stricter requirements for manufacturers of medical devices
The European Union’s new Medical Device Regulation (2017/745), or MDR, will become fully applicable in May 2021 and is expected to replace the existing Medical Device Directive (MDD) and Active Implantable Medical Devices (AIMD) Directives. The old directive on in vitro diagnostic medical devices (IVD) is no longer included in the MDR, but has been replaced by a separate new EU regulation (In Vitro Diagnostic Medical Devices Regulation, IVDR). This means that manufacturers of medical devices are faced with stricter requirements in order to be able to market their products in the EU. In terms of language too. The new regulation also means that more products than ever before fall into the category of “medical devices”, for example coloured contact lenses that do not require a prescription.
The new regulations are intended, among other things, to increase safety for patients and transparency, as well as to contribute to fair market access. For manufacturers, they mean a massively increased workload, as they have to ensure that their products comply with the MDR through a conformity assessment based on risk classes. Every medical device must have an identification number (UDI). The MDR also requires manufacturers to submit additional reports and extensive documentation. And this is where the language aspects and therefore translations, localization and language service providers come into play.
Impact of MDR on translation and localization
Professional translations without any errors have always been of great importance, especially in the medical device and life sciences industry, as they ensure that users of different languages can use a product appropriately. If misleading instructions are misinterpreted, this will result in unforeseeable risks for the product, the user and/or the patient. However, the new MDR makes it clear that wording and formulation are increasingly regarded as an integral part of the product and are therefore subject to equally strict regulations.
We are familiar with these regulations. As certified language service providers who have been translating medical technology texts for over 70 years, we have been dealing with the MDR for a long time. We are familiar with the requirements for technical documentation content, which will be regulated in much greater detail in future, and also with the new specifications for the labelling of medical devices, and feel perfectly equipped to assist manufacturers not only in terms of language and content/editing, but also in terms of procedures when implementing the new MDR.
We will be happy to advise you personally and discuss the concrete stages of the procedure for your specific products with you.