An official list of language requirements for each EU Member State has been published by the European Commission. This critical document also lists translations required for Graphic User Interface (GUI) used for software / apps, although this information is not available for each country. What’s more, these requirements have been published for both MDR and IVDR legislation.
Surprisingly, the document also provides an indication of which language is accepted for devices used by the patient and by the professional user (making an important risk-based distinction). Reading through each Member State, it’s evident that for professional use medical devices, the use of English is widely accepted, although most countries still require this to be in their native language.
This is one of those documents which we recommend that you download and keep controlled as part of your Quality Management System and as a reference document in your design control procedure.
In all, the tables published indicate the following language requirements for each Member State:
- Label / IFU (Patient/Professional User).
- Implant Card.
- Declaration of Conformity.
- Field Safety Notice.
- Documents for Conformity Assessment.
- GUI Interface (Patient/Professional User).
Whilst we’re on the subject of translation, it’s important to keep in mind that, in this case, Google Translate is not recommended. Inaccuracies in translation can mean the difference between correct and incorrect use of the device, and thus using an accredited translation company ensures that the language being used will be easily understood by native speakers.
A few years ago, it may have been sufficient to ask your distributor to translate your documents into their native language, however, this is no longer viable and Notified Bodies (if they apply to you) will expect you to use an agency that has been accredited against ISO 17100:2015.
You can find the download links for the MDR and IVDR language requirement tables at the following link.