Expanded rules for electronic instructions for use (eIFUs)
Effective: Published June 27th, entering into force 20 days later
Amends: Commission Implementing Regulation (EU) 2025/1234
Purpose: To broaden the scope of devices eligible to provide IFUs in electronic form instead of paper.
What changed?
The EU now allows all medical devices and their accessories intended for professional users to provide electronic Instructions for Use (eIFUs). This means the scope is no longer limited to devices like (active) implantables, fixed installed medical devices, and devices with a built-in system for visually displaying instructions. This change responds to industry demand and digital transformation trends.
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Below you'll find the key highlights of the regulation, or you can consult the document of the Official Journal of the European Union.
Key highlights
1. Wider scope of eligibility
- All devices and their accessories intended for professional use are now eligible
- Applies even to devices without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
- Devices under transitional MDR provisions are included
- If lay persons are likely users, a paper IFU is still required for them
2. Compliance requirements remain strict
- A documented risk assessment is still mandatory
- Manufacturers must ensure:
- Secure and user-friendly access to eIFUs
- Backup and emergency protocols
- Website uptime and data protection (GDPR)
- Paper IFUs must be available on request, within 7 days
3. Labeling and website requirements
- Product labels must indicate eIFUs are provided
- Website must host current IFU and historical versions must be at least made available on request
- eIFUs must be accessible in official EU languages, as applicable
- From the moment registration in EUDAMED becomes mandatory, internet access URLs must be registered
What this means for you
You can now:
- Replace printed IFUs for a much wider range of devices
- Digitize documentation workflows, reducing costs
- Improve update speed and support sustainability goals
But you must still meet strict EU MDR/IVDR requirements regarding the IFU for content, delivery, labeling, and traceability.
IFUcare can help
Commission Implementing Regulation (EU) 2025/1234 opens the door much wider for manufacturers to adopt electronic IFUs but it also reinforces the need for controlled access, version tracking, and alignment with EUDAMED.
IFUcare can support full eIFU compliance. Our platform offers:
- Commonly used formats: we provide eIFUs in widely accepted formats that can be read with freely available software.
- Security: robust protection against hardware and software intrusions to safeguard your information.
- Minimal downtime: our platform is designed to reduce server downtime and display errors, ensuring that your eIFUs are always available.
- Multilingual support: clear indication of the languages in which the eIFUs are provided.
- Stable internet address: guaranteed stable and accessible internet address for your eIFUs, in compliance with regulatory requirements.
- Version control: access to all previous versions of your eIFUs and their publication dates.
