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.
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.
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...
