How EU Medical Device Regulation Affects Translation Services
Script:
- 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.
- Given the fact that companies must comply with these new regulations, medical device firms must seek the help of professional language services.
- The role of healthcare translation services in MDR compliance
- 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.
- Under the 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.
- 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.
- Finally, in order to ensure full compliance with the EU MDR, companies should choose a global translation company with experience working in the medical field.
- This reality has become even more important due to the fact that under the 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 EU MDR requires that medical device companies hire the best translation company for the job.
- With over 30 years of experience providing professional translation for firms in the medical industry, Language Connections is happy to serve as a key partner for 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, international development translation, education translation, 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.
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