In order to have bioproducts such as medical devices approved by health authorities outside of the United States, companies need to be not only aware of their products’ safety and effectiveness, but also sure that they include accurate documentation. There are several documents that need to be carefully filed and submitted, many of which require translation into foreign languages. While the language translation process for medical devices and other bioproducts can be time consuming and difficult to manage, there are some best practices that can be followed in order to minimize costs and time.
When applying for approval in the European Union (EU), biotechnology companies begin the process by filing original documentation that includes Instructions for Use (IFU), Material Safety Data Sheets (MSDS), operation manuals, installation guides, labels, and decals for medical devices. The IFU is particularly important for a medical device since it contains information provided by medical device manufacturers about the device, its proper use, and safety precautions.
In Europe in particular, all products are required to have a CE Mark, guaranteeing that their safety and authenticity are verified and properly translated, enabling manufacturers and traders to commercialize them in the European Economic Area (EEA). The CE Mark, as well as all other documentation for medical devices, such as IFUs, need to be translated into all 24 official languages of the European countries.
This means that in order to get a medical product approved in the EU, companies need to translate the documentation, requirements and labels for their product into Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish and Swedish in addition to providing native English documentation.
When beginning the management of a translation project for IFUs or other key documentation for CE Mark approval, there are some recommendations that are generally useful. One best practice is to compile a set of glossaries and styles for technical terminology, abbreviations, and acronyms, which may be reused on multiple applications and projects for different medical products and devices. This is particularly helpful if submitting products or devices to the European Medicines Agency (EMA) or other governing bodies in the EU is to be an ongoing process.
In addition, during the translation process, it is best to avoid the use of abbreviations and acronyms in the source documentation, which may cause confusion in other languages. Multiple synonyms, colloquialisms and metaphors are also to be avoided; these are unnecessary and difficult to translate, and reduce universal understanding. Maintaining a simple, clear and consistent text that explains the purpose of the product and other required information is considered the best approach.
Despite the fact that some companies are already accustomed to the application and approval process with the U.S. Food and Drug Administration (FDA), there are major procedural differences in the EU — particularly as they pertain to translation into multiple languages — that may complicate the approval of a medical device or product and its entry into the EU market. Bioproducts are highly regulated throughout the EU, and selling a product without having the proper authorization and CE Marking is punishable. If a company is caught commercializing a CE-Marked product without proper translated information, usually after a complaint from a competitor or customer or due to a random check, it may trigger an investigation from the regulatory body, requesting the company to further clarify the information and justify why certain information is not translated.
Large medical device firms that have to deal with translating IFUs and other documentation on a regular basis sometimes opt for building their own in-house translation team. However, for the majority of medical device companies, hiring translation firms with proven knowledge and experience in translating IFUs for medical devices for the CE Mark is often the most cost-effective and safe approach to ensuring proper submission and approval. EU officials not only expect translated IFUs to be clear, concise, and explanatory for the country that they are being marketed in, but also look to ensure that the translations are accurate and consistent compared to one another across the 24 languages in the EU. In order to ensure this, working with one central translation firm that can manage the project as a whole ensures that the translations will be consistent with one another, as opposed to hiring multiple freelance translators who are not centrally managed as a team and do not communicate with one another.
When choosing a translation firm for medical device IFU projects, be sure to ask for the company’s previous experience in similar projects. While no two translation projects are the same, finding a company that has done similar work in the past successfully is essential to making sure that the translations for your company’s products are in compliance with EU regulations.