Blog · 9 December 2025

What is eIFU? Electronic instructions for use explained

eIFU stands for electronic Instructions for Use — providing the instructions that must accompany a medical device in digital form instead of on paper. Users typically access the document on the manufacturer's website or a dedicated portal, often by entering the product's REF or UDI code printed on the label.

The legal framework in the EU

The obligation to supply instructions for use comes from the Medical Device Regulation (EU) 2017/745 (MDR). The conditions under which those instructions may be provided electronically are set out in Commission Implementing Regulation (EU) 2021/2226. Since 16 July 2025, Implementing Regulation (EU) 2025/1234 has extended the eIFU option to all medical devices intended for professional users — read our summary of what changed.

Key conditions for compliant eIFU

• A documented risk assessment showing that electronic provision maintains or improves safety.
• The instructions are available on the manufacturer's website in a commonly used format, protected against tampering and guaranteed to be accessible.
• The label or packaging clearly states how to access the electronic instructions.
• A paper copy on request, free of charge, delivered within the prescribed time.
• Instructions remain available for the required period after the last device is placed on the market, with all versions archived.
• Paper stays mandatory for lay users.

Why manufacturers switch to eIFU

• Cost savings — no printing, packaging inserts or physical distribution; savings grow with every SKU and language version.
• Faster updates — corrected safety information reaches users immediately, not with the next print run.
• Always current documentation — no outdated manuals circulating in the field.
• Sustainability — tons of paper saved every year.
• Better usability — searchable, zoomable, multilingual documents available anywhere.

What an eIFU platform must handle

Publishing a PDF on a website is not enough. A compliant eIFU solution needs guaranteed availability, secure hosting, version and language management, document access via REF/UDI code, an audit trail, and a process for paper copies on request. DocuLiv provides all of this as a cloud service — no hardware to buy, quick to implement, priced by the size of your portfolio.