According to the new EU Regulation concerning Medical Devices (MDR) coming into force on May 26th 2021, it is up to distributors/importers to “ensure that the translation of information is accurate and up-to-date”. Therefore, you need trusted translators. Translating Health can help!
Medical translations of instructions for use aren’t easy. But Eudamed, the medical device database that will be created according to the (EU) Medical Devices Regulation (MDR 2017/745), will hopefully help clarify ambiguities and improve consistency.