The marketing of medical devices in Europe was regulated from 1994 to 2017 by the so-called Medical Device Directive or “MDD”. This legislative resource was of great importance for business relations in the health sector since it led to the creation of a legal framework that would regulate the manufacture of medical devices, assess their quality in accordance with European requirements, and ensure that they met all the standards required for their entry into the different markets. Over the years, however, it became clear that this directive had some shortcomings, since it did not include certain devices and these devices were not classified in an easily traceable and recognizable way. As a result, the European Medical Device Regulation or “European MDR” was approved in 2017.
Although none of its provisions were removed, the scope of action of the new text includes certain devices that lack a medical function, single-use reprocessed medical devices, devices used for disinfection, cleaning and sterilization, as well as other auxiliary and implantable medical devices. A new classification system based on classes of medical devices was also proposed in the European MDR and, moreover, an individual product identification system, known as UDI or “unique product identifier”, was created. As a result, the MDD has become obsolete and the European MDR is the framework that governs all business relations in the health sector. This, of course, has had a significant impact on the language services sector, since the drafting guidelines for texts related to medical devices follow specific guidelines that must be reflected in translations. In addition, translations themselves have become an essential element for such international marketing, meaning that now, more than ever, ensuring an accurate, professional and quality translation is key to achieving success with the launch of any medical product. But what does this really mean?
To begin with, in accordance with the European MDR, manufacturers of medical devices must translate all medical device documentation into the languages of the European Union. Therefore, information about any device must be available in any language of countries belonging to the European Union, so that their citizens can easily understand all that is related to said device, whether in general or in the professional field. This undoubtedly represents a major boost for the translation sector, but also creates the challenge of finding reliable translation providers who produce good translations.
This leads us to the next point: in order to obtain the European CE marking certificate, it is often necessary to submit the translation of several relevant documents, such as the Instructions For Use (IFU), into all European Union languages. Although the original document is always taken as a valid reference, an erroneous translation can make it difficult to obtain such approval, which is why specialized services should be contracted in this area. Otherwise, manufacturers put their business efforts at risk.
One of the requirements set forth by the new regulation is that the wording must be clear and concise, in addition to using standardized terminology that promotes language consistency in all texts of the medical devices sector. Labels, instructions for use, safety instructions and many other documents should be easily understood by anyone, for which reason they should be in their language and always contain the same terminology. It goes without saying that guaranteeing standardized terminology in this sector is challenging, since each manufacturer may have different names for the different products. As such, numerous resources have been created to be able to conduct terminology and information consultations, such as the FAO Terminology Portal and the EUDAMED database, two essential tools for professional healthcare translators.
In short, it is apparent that the marketing of medical devices is a sector that largely depends on translation and in order to be successful, said translation must be of an incredibly precise, technical and versatile quality, since its aim is to relay messages to both the specialized public and the general public. Therefore, when selecting a translation agency, it is necessary to entrust our needs to those that are the most professional, since they will make sure that the most suitable experts are involved in the processes, in addition to safeguarding the privacy of information that is so characteristic of the industry.
At Montero Language Services, we have a directory of professional translators who are specialized in texts on medical devices and are perfectly familiar with European MDR terminology. This makes us a trusted partner for all interested parties in the market of medical device internationalization.
Image reference: https://www.tuv.com/landingpage/en/medical-device-testing-and-auditing/main-navigation/
