Language requirements for IFUs and labels under the MDR and IVDR
The language requirements outlined in the MDR and IVDR are, at their core, clear and straightforward. Simply put, all information provided with a medical device — the label, instructions for use, implant cards, or any other relevant materials — must be in the official language(s) of the EU Member State where the device is being made available. This ensures that users, whether patients or healthcare professionals, can easily understand and safely use the device. No complex interpretations or guesswork required — just ensure the information is accessible in the accepted language of the country, and you’re good to go.
In some EU countries though, labels and Instructions for use can be provided either in the national language(s) or in English, if the device is intended for use by medical professionals. Countries that allow this flexibility include Germany, Austria, Belgium, Cyprus, Estonia, Ireland, Malta, Poland, and the Netherlands. Meanwhile, other countries like Finland, Denmark, Latvia, Romania, and Croatia also permit the use of English for professional users, but only under specific conditions or when justified.
When it comes to lay users, only Malta and Ireland accept English since it is widely spoken and essentially considered a native language in these countries. For all other EU Member States, devices intended for laypersons must have labels and IFUs in the respective national language(s) to ensure accessibility and understanding.
Implant cards can be provided either in the national language or in English in several EU countries, offering some flexibility depending on patient preference and regulatory allowances. In Belgium, implant cards may be in English if that is the patient’s choice. Cyprus also permits English for implant cards. In Finland, implant cards should be available in Finnish, Swedish, and English. In Ireland, the cards must be either in English or in both English and Irish. Malta accepts English implant cards, and in Sweden, implant cards can also be provided in English, catering to diverse language needs and patient preferences.
When it comes to the graphical user interface of medical software, it is generally treated in different countries in a similar manner to IFU regarding language requirements in those countries, with distinctions made between professional and lay users. For professional users, GUIs can often be provided in English, especially if they are familiar with the software’s technical terms. However, for lay users, the GUI typically needs to be in the national language to ensure clarity and proper understanding, aligning with the standards set for IFUs to make the device accessible and safe for all users.
Unlike the language requirements for information that reaches the user, the documentation required for conformity assessment is generally accepted in English across almost all EU countries. In some Member States, there are no specific language requirements mentioned in their national regulations for conformity assessment documents. But these are mostly countries without Notified Bodies conducting conformity assessments.
