eIFU (Electronic Instructions for Use)
An eIFU (electronic instructions for use) is the digital provision of a medical device's instructions for use instead of or in addition to the printed paper version. The legal basis is EU Regulation 207/2012, which was updated by Regulation (EU) 2021/2226 in the course of alignment with the EU MDR. An eIFU can be provided via a manufacturer's website, through access information on the product or packaging (e.g. URL, QR code), or through integrated software displays. The manufacturer must ensure that the eIFU remains available for the entire expected lifetime of the product and is provided in all required language versions.
For IFU translation, the eIFU offers significant advantages: updates can be published simultaneously across all language versions without reprinting and repackaging. This accelerates the implementation of changes arising from market surveillance and reduces version management costs. At the same time, the requirements for a reliable content management system increase, as it must consistently manage all language versions and maintain complete technical documentation.
Frequently Asked Questions
Under what conditions may an eIFU be provided instead of printed instructions for use?+
EU Regulation 207/2012 (supplemented by EU 2021/2226 under the EU MDR) stipulates that electronic instructions for use may replace the printed version under certain conditions. Prerequisites include: the medical device must be intended for safe use by professional users, the manufacturer must conduct a risk analysis, the eIFU must be permanently and freely accessible via a website, and there must be an option to obtain a printed version upon request. All linguistic requirements of the EU MDR apply unchanged – the eIFU must be provided in the same languages as a printed version would be.