Implementing Regulation (EU) 2025/1234, in force since 16 July 2025, amends Regulation (EU) 2021/2226 and significantly extends the possibility of replacing paper instructions for use with electronic instructions for use (eIFU).
The main novelty: extended scope
Until now, only certain product categories could use eIFU. With the amendment, those restrictions are removed: eIFU is now possible for practically all medical devices intended for professional use, including the products without a medical purpose listed in Annex XVI of the MDR (Regulation (EU) 2017/745). Devices intended for non-professional (lay) users generally remain outside this framework.
What the manufacturer must do
Opting for eIFU is not automatic. The manufacturer must:
- Document a risk assessment demonstrating that the eIFU provides a level of safety at least equivalent to paper, considering the user profile and their access to technology.
- Provide a free paper copy to anyone who requests it, within a maximum of 7 calendar days.
- Publish the eIFU in the official languages required by each Member State where the device is marketed, with the same content as the printed version.
- Clearly inform users how to access the eIFU. On access, the device UDI and the manufacturer’s contact details must be displayed.
- Communicate in a traceable way any change to the instructions that is relevant to safety.
- Register the eIFU URL in EUDAMED (UDI database) where UDI registration is mandatory.
Overview of the key requirements
| Requirement | Responsible party |
|---|---|
| Carry out a documented risk assessment for the use of electronic instructions for use. | Manufacturer |
| Demonstrate that the electronic instructions for use provide at least the same level of safety as paper instructions for use. | Manufacturer |
| Provide electronic instructions for use in the Member States where the device is made available. | Manufacturer |
| Supply a paper copy of the instructions for use free of charge upon request within the specified period, no later than 7 calendar days. | Manufacturer |
| Provide information on medical emergency situations and device start-up procedures (for devices with a built-in display). | Manufacturer |
| Ensure the correct design and functioning of the electronic instructions for use. | Manufacturer |
| Provide the instructions for use in the official EU language required by the relevant Member State. | Manufacturer |
| Provide information on how to access the electronic instructions for use. | Manufacturer |
| When accessing the instructions for use, the UDI information and the manufacturer’s contact details must be displayed. | Manufacturer |
| Submit the eIFU URL to the UDI database (EUDAMED) once UDI registration becomes mandatory. | Manufacturer |
| Ensure the website is protected against unauthorised access and tampering. | Manufacturer / Website operator |
| Minimise website downtime and display errors. | Manufacturer / Website operator |
| Ensure compliance with GDPR requirements. | Manufacturer / Website operator |
For how long must the eIFU remain available
- General rule: 10 years from the placing on the market of the last device, and never less than 2 years from the end of the lifetime of the last device produced.
- Implantables and devices without an expiry date: 15 years from the placing on the market of the last device.
Both the current version and the historical versions of the instructions must remain accessible.
Website requirements
The website hosting the eIFU must be protected against unauthorised access and tampering, comply with the GDPR and guarantee high technical availability: downtime and display errors minimised throughout the entire retention period.
How we can help
These requirements demand close integration between the instructions for use and the UDI data. With MeDev and the eIFU application, both are managed on a centralised platform that links the electronic instructions to the registered devices. Request more information through our contact form.