eIFU under Regulation (EU) 2025/1234: what changes for medical device manufacturers
Reviewed 7 October 2026 · Sources: EUR-Lex · By Scan & Care · Not legal advice
The short answer
Since 16 July 2025, manufacturers may provide instructions for use in electronic form instead of on paper for any medical device intended for use by professional users. Before, the option was limited to a closed list of device types. Paper remains mandatory for instructions intended for lay persons, and the documented risk assessment, the 7-day paper-on-request rule and the website requirements of Regulation (EU) 2021/2226 still apply.
What is Regulation (EU) 2025/1234?
Commission Implementing Regulation (EU) 2025/1234 amends Implementing Regulation (EU) 2021/2226, which sets the conditions under which manufacturers of medical devices can provide instructions for use (IFU) in electronic form (eIFU) instead of in paper form under Regulation (EU) 2017/745 (MDR). It was adopted on 25 June 2025, published in the Official Journal on 26 June 2025, and entered into force on the twentieth day after publication, that is on 16 July 2025.
What changed compared with Regulation (EU) 2021/2226?
| Before (2021/2226) | Now (as amended by 2025/1234) | |
|---|---|---|
| Devices that can have eIFU | A closed list of device types, such as implantable and active devices and fixed installed devices, for exclusive use by professional users | Medical devices intended for use by professional users, including devices placed on the market under the transitional provisions of Article 120 MDR and products without an intended medical purpose listed in Annex XVI MDR |
| Use by lay persons | Use by other persons must not be reasonably foreseeable | If it is reasonably foreseeable that a professional-use device is also used by lay persons, the instructions intended for lay persons must be provided on paper |
When is a paper IFU still required?
- Lay persons. For devices intended for lay persons, and when use by lay persons of a professional-use device is reasonably foreseeable, the instructions intended for them must be on paper.
- On request. Whatever the device, users must be able to obtain a paper copy. The paper version must be provided at no additional cost, within the time set in the risk assessment and at the latest within 7 calendar days of the request (or at delivery, if requested when ordering the device).
What must manufacturers still document and provide?
- A documented risk assessment considering the knowledge of the intended users, the environment of use, access to electronic means, protection against tampering, medical emergencies and unavailability of the website.
- Information on the device or its packaging that the instructions are provided in electronic form and how to access them.
- A website that meets the technical requirements: readable with free software, protected against unauthorised access, compliant with data protection rules (GDPR), with every issued version and its publication date.
- The internet address of the eIFU in the UDI/device module of EUDAMED, where registration is mandatory.
How does a QR code fit in?
The regulations do not prescribe a QR code, but a QR code on the label or packaging is a common way to give users immediate access to the current version of the eIFU on the manufacturer's website. Whatever the technology, the manufacturer remains responsible for the risk assessment, the content of the instructions, version control and the availability of the paper copy on request.
Where Scan & Care fits
Scan & Care is a SaaS portal, hosted in the EU, to publish and update IFUs, leaflets and manuals as digital documents reachable through a QR code, with versioning, multilingual documents and paper-copy requests. It supports the operational side. It does not replace the manufacturer's regulatory assessment.
Start free for 12 months Calculate your paper costFrequently asked questions
Can I stop printing instructions for use for all my medical devices?
No. Regulation (EU) 2025/1234 allows eIFU for devices intended for professional users. If it is reasonably foreseeable that a professional-use device is also used by lay persons, the instructions intended for lay persons must be provided on paper. Devices intended for lay persons are not covered by this option.
Do I still need a risk assessment to use eIFU?
Yes. The conditions of Regulation (EU) 2021/2226 still apply: the manufacturer must document a risk assessment that takes into account, among other things, the knowledge of the intended users, the environment of use, access to electronic means, protection against tampering, medical emergencies and the unavailability of the website.
How quickly must a paper copy be provided on request?
Under Regulation (EU) 2021/2226 (Article 5(3)) the manufacturer must have a system in place to provide the paper version at no additional cost to the user, within the time set in the risk assessment and at the latest within 7 calendar days of receiving the request, or at the time of delivery if the paper copy was requested when ordering the device.
What has to be provided to EUDAMED?
When registration in the UDI/device module of EUDAMED is mandatory, manufacturers must provide the internet address where the electronic instructions for use can be accessed.
Sources
- Commission Implementing Regulation (EU) 2025/1234 (EUR-Lex)
- Commission Implementing Regulation (EU) 2021/2226 (EUR-Lex)
This page is a plain-language summary for information only. It is not legal advice. Always refer to the official text and to your regulatory affairs adviser or notified body before changing how your instructions for use are provided.