In 2017, the European Parliament passed the European Union Medical Device Regulation (MDR). This new law introduced a variety of changes to the medical device manufacturing industry, including stricter oversight regulations and improved transparency rules. Yet one of the most transformative aspects of this new law is its translation requirements. According to this provision of the MDR, all informational materials related to medical devices (i.e. labels, instruction manuals, safety information, etc.) must be translated into the 24 official languages of the E.U. These materials also must be easy to read and provide pictures and data to ensure the readers’ understanding. Given the fact that companies must comply with these new regulations by May 26, 2020, medical device companies must seek the help of exemplary language service companies such as Language Connections for their healthcare translation services.
The Role of Healthcare Translation Services in MDR Compliance
The medical device industry is an incredibly high-stakes field. Inaccuracies in safety manual language or promotional materials pose great risk to clients who are often ill-informed or not fully aware of the medical repercussions of their healthcare choices. Therefore, it is essential that medical device companies choose language service providers that demonstrate a clear commitment to clarity and accuracy in their translations.
Medical device firms should also partner with language service companies who are able to work efficiently under time constraints. Under the EU’s new regulations, technical dossiers for medical devices must include the product’s safety information and instruction manual translated into each of the EU official languages. This is a time-consuming process. It is only after a careful review of these documents that the device can be approved for use in the EU. Complying with these strict regulations by the deadline can be extremely difficult for companies, especially small ones. As a result, medical device companies should go to great lengths to find the best translation company with a reputation for reliability and efficiency. This is a must when dealing with a compliance deadline.
Finally, in order to comply with the EU MDR, companies should choose a global business translation services company with experience working in the medical field. Complicated medical device manuals cannot be adequately translated if the hired translators lack industry expertise, as they often include difficult medical jargon and technical terms. This reality has become even more imperative due to the fact that under the EU MDR, all informational materials must be provided to consumers in all of the official EU languages through the new European Database on Medical Devices (EUDAMED). Thus, the utmost attention to detail must be paid to the translation of medical device manuals.
Conclusion
Clearly, the 2017 EU MDR requires that medical device companies hire the best translation company for the job. With over 25 years in the field of professional business translation and with extensive experience working for firms in the medical industry, Language Connections would be happy to serve as a partner for your medical device translation projects.
About Language Connections:
Language Connections is one of the top language service companies in the US. Over the last 30 years, we’ve focused on providing the best business translation services, interpreting services, as well as interpreter training and customized language training programs. In addition to top-tier corporate language training, we offer certified corporate interpreters and professional business translation services in 200+ languages. Our network includes linguists with backgrounds in all major industries. They’re ready to meet your needs, whether they’re for technical translation services, legal translation, government translation services, international development translation services, education translation services, life sciences translation, or something else. Reach out to us today for a free quote on our cost-efficient and timely translation services, interpreters, or other linguistic services.
Language Connections Inc.
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Boston, MA 02135
Phone: +1-617-731-3510
Email: service@languageconnections.com