IFU (Instructions for Use)
An IFU (Instructions for Use) is the document accompanying a medical device that contains all information necessary for its safe and intended use. It is a mandatory component of product labelling under the EU MDR (Regulation (EU) 2017/745) and must include information on intended purpose, safety warnings, contraindications, and usage instructions. The IFU must be provided in the official language of each target market.
The IFU is the central document in the translation process for medical devices. Incorrect or missing translations can lead to market entry delays, objections from Notified Bodies, or even patient safety risks.
Frequently Asked Questions
Into which languages must an IFU be translated?+
According to EU MDR Article 10(11), the IFU must be provided in the official language(s) of the Member State where the medical device is made available to the user or patient. In practice, this means up to 24 language versions for the entire EU market.