Efficient language solutions in the context of MDR 2017/745
EU Regulation MDR 2017/745 comprehensively governs the safety and marketability of medical devices. It requires that technical documentation, instructions for use, and labeling are available in up to 24 official EU languages to ensure legal certification. This is not merely a linguistic translation – the content must be precise, clear, and formulated in accordance with regulatory requirements. Translation services must ensure that medical terminology as well as the specific requirements of medical technology are implemented consistently and accurately in all target languages. Due to the complexity of the MDR, error-free translation is crucial, as even small deviations can have significant impacts on product safety and approval. For further information on the MDR, please click here.
Dialecta works with a network of qualified specialist translators who are experts in medical device documentation. We ensure not only linguistic precision but also the compliant implementation of complex technical content. Our ISO DIN EN 17100 certified processes guarantee that the translations meet MDR requirements while ensuring comprehensibility for professionals and end users.
Translation into up to 24 EU languages requires precise project management and close collaboration with authorities. Dialecta ensures that all deadlines are met while maintaining the highest level of accuracy. Our network and processes are designed to handle demanding projects efficiently and on schedule.
Our DTP department ensures that translated documents are perfectly formatted in all languages and adapted to local requirements. Dialecta ensures that technical drawings, graphics, and tables are accurately reproduced. Additionally, our specialist proofreading team reviews all translations to guarantee a consistent and precise presentation of the content – a crucial factor in minimizing regulatory risks.
We support manufacturers in meeting the requirements of MDR 2017/745 through precise translations and compliant documentation. Dialecta assists in the certification process with expert translations for instructions for use, labeling, packaging, or brochures. Our optimized processes and specialist proofreading enable your products to reach the market quickly throughout the EU.
Our expertise in MDR 2017/745 goes beyond mere translation. We ensure that all documents comply with the legal requirements of each EU market. This includes precise linguistic implementation, consideration of technical specifications, and adaptation to local regulations – in other words, comprehensive localization. Thanks to our close collaboration with authorities, we are always up to date.
Our many years of experience and optimized workflows enable us to coordinate translation projects efficiently. With a portfolio of over 3000 specialist translators and our focus on on-time delivery, we support companies in bringing their medical devices to market faster and without compromising quality.
