What is an IFU — and what is an eIFU?
IFU stands for "Instructions for Use". Discover what going electronic means for manufacturers.
In short
eIFU stands for electronic Instructions for Use: the regulated online publication of instructions for use and related labelling for medical devices and in vitro diagnostics. In the EU, eIFU is permitted under Regulation (EU) 2021/2226 for medical devices and Regulation (EU) 2017/746 for IVDs, provided the documents stay version-controlled, multilingual and available on request in paper.
What does IFU stand for in medical devices?
Distribute your documents online on a pre-configured website that supports rapid validation
eIFU stands for "electronic instructions for use", but the term encompasses more than just these documents. It also includes the online distribution of other regulatory documents, such as certificates of analysis, safety data sheets, and quality control documents.
eIFU can be made available via a manufacturer's website but due to the strict regulations, these websites must be validated for compliance. IFUcare removes this burden and offers a pre-configured website that supports rapid validation and still matches your corporate identity. Moreover, maintenance and continued compliance are ensured.
Why choose eIFU over paper?
Make changes faster
If changes need to be made, it takes time to recall the product, replace the paper IFU and redistribute the product. With electronic IFUs, updates can be made in minutes, reducing the likelihood of a product recall.
Reduce risk
Providing eIFUs with better readability and ensuring that documents are always available reduces the risk of errors and improves patient safety.
Save paper and costs
Switching to eIFU is better for the environment and saves your company the cost of printing and managing documents. It also reduces packaging and shipping costs.
Simplify your process
We make your eIFU easy to access and keep track of all version changes. We believe that technology should make your and your customers' lives easier.
Improve readability
You have more options for displaying the information in your eIFU – they can be in larger font, and can include colours and images to make them easier to understand.
Common questions about eIFU
Is an eIFU website mandatory in the EU?
No. Electronic Instructions for Use are an option, not an obligation. Regulation (EU) 2021/2226 allows manufacturers of specific medical devices to supply instructions for use electronically instead of on paper, and Regulation (EU) 2017/746 sets the equivalent conditions for in vitro diagnostics. Once you choose eIFU, the conditions of those regulations become mandatory.
What does Regulation (EU) 2021/2226 require from manufacturers?
It requires a risk assessment for electronic-only supply, a website that presents the instructions for use in the languages of the countries where the device is sold, clear indication of the device versions each document applies to, retention of superseded versions, and a paper copy supplied free of charge on request within a defined period.
Which devices can use electronic Instructions for Use?
Regulation (EU) 2021/2226 limits electronic-only instructions to defined categories, such as devices installed permanently, implantable and implantation-related devices, and software as a medical device, and only when the device is intended for professional use. Devices for lay users still require paper instructions for use.
How do you keep an eIFU website compliant over time?
Compliance is a lifecycle activity rather than a launch project. You need version history for every document, an audit trail of who published what and when, translations kept in step with the source document, uptime and security controls for the website, and a documented process for paper copy requests and regulatory change monitoring.
Do you still have to provide a paper copy of the IFU?
Yes. Users must be able to request a paper copy free of charge and receive it within the timeframe set by the regulation. IFUcare covers this with a 24/7 multilingual freephone service and paper copy fulfillment in over 50 countries.
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eIFU regulation (EU) 2025/1234
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Ready to make the switch?
See how IFUcare can transform your document distribution with our pre-configured eIFU platform.