Regulations (EU) 2017/745 and 2017//46 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) clearly require that manufacturers must translate labels and instructions for use (IFU) according to national market provisions. The latter point was often perceived a challenge as clear guidance which markets require translations was not accessible easily.
The European Commission provided tabular overviews regarding the language requirements in different member countries for the MDR and the IVDR. The tables refer to specific provisions for labels and IFU, implant cards, declarations of conformity, field safety notices, documents for conformity assessment and graphical user interfaces, e.g. in apps.
It is noteworthy that the documents say the Commission does not take responsibility for the correctness of the included information and that legal provisions take precedence over the information in the tables. We thus think manufacturers should still screen available information on language translations, but the two tables give a good overview of the current status.
Please let us know should you wish mdi Europa to send the corresponding documents to you.
You can find the files in our library of download them here:
Source: European Commission