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Implementing electronic Instructions For Use (eIFU) under (EU) 2025/1234
The transition to electronic instructions for use (eIFU) is a technical shift for regulatory teams. Regulation (EU) 2017/745 (MDR) set the initial path, and (EU) 2021/2226 established the framework for professional use. The publication of (EU) 2025/1234 removes previous category based limits, opening digital formats for all professional devices and Annex XVI products.
1. From IFU to eIFU
The following table shows the legal path to electronic instructions:
| Legal Instrument | Regulatory Impact |
|---|---|
| (EU) 2017/745 / (EU) IVDR 2017/746 | Sets the general requirements for instructions for use and mandates that if a manufacturer has a website, this information must be made available and kept up to date online. |
| (EU) 2021/2226 | Established the specific conditions under which paper instructions could be replaced by electronic versions for certain categories, such as implantable or fixed installed device |
| (EU) 2025/1234 | Expanded the scope to allow electronic instructions for all medical devices intended for professional users and introduced the requirement to provide the website address to the Eudamed UDI database. |
2. Key changes in Regulation (EU) 2025/1234
(EU) 2025/1234 update brings technical changes that move past the old list of allowed devices:
Expanded scope : Article 3 no longer lists specific categories. Digital instructions are now allowed for all medical devices and accessories meant for professional use. This includes products without a medical purpose that are listed in Annex XVI.
Easier distribution : Article 5(12) of the 2021 rules is gone. Manufacturers no longer need to track and tell every person who downloads a file about an update. This work now happens through post-market surveillance & vigilance (e.g FSCA)
Version control and EUDAMED : Article 5(13) allows manufacturers to give old versions when asked instead of keeping every single file on the public site. A new rule in Article 7 says the web address for these instructions must go into the Eudamed UDI database when registration starts.
3. Technical requirements of eIFU
Manufacturers must confirm that the digital method is just as safe as paper :
| Requirement Category | Reference | Implementation Solution |
|---|---|---|
| Risk management | Art. 4, (EU) 2021/2226; ISO 14971 | Update risk files to include digital failure modes like server issues, internet latency, and hardware obsolescence. Document how to keep users safe if they lose digital access during clinical procedures. Keep in mind the final users / patient. |
| Device eligibility | Art. 3, (EU) 2025/1234 | Verify that the device is intended for professional use only. If lay users are involved, a paper version remains mandatory in the packaging. |
| Display safety | Art. 5(6), (EU) 2021/2226 | Confirm that the digital display of instructions does not cover up vital safety data or monitoring alarms on the device screen. |
| Emergency access | Art. 5(4), (EU) 2021/2226 | Put medical emergency data and startup steps on a paper leaflet or on the device itself. This bypasses digital access needs in critical moments. |
| Paper copy delivery | Art. 5(3), (EU) 2021/2226 | Set up a logistics procedure to send paper copies within 7 calendar days of a request. This service must be provided at no cost. |
| Labelling and identification | Art. 6, (EU) 2021/2226; ISO 15223-1 | Use symbol 5.4.3 (ISO 15223-1) on the packaging. Add the web address and UDI-DI so the user finds the correct version matching their specific lot. |
| Data integrity and security | Art. 7(2)(b), (EU) 2021/2226 | Use read only files like PDF. Verify that servers are protected against unauthorized document changes. |
| Infrastructure and uptime | Art. 7(2)(c), (EU) 2021/2226 | Use server backups and redundancy to make sure the site stays up. Maintain the site for 10 years (15 years for implants) after the last unit is sold. |
| User privacy and GDPR | Art. 7(2)(d), (EU) 2021/2226; (EU) 2016/679 | Build the site so people can see files without signing up or giving personal data. |
| Language requirements | Art. 5(11), (EU) 2021/2226 | Provide the text in the official Union languages required by the Member States where the device is commercialised. (MDR - Language requirements for manufacturers) |
| Eudamed registration | Art. 7(3), (EU) 2025/1234 | Have a process to add the stable web address to the Eudamed UDI database in line with Annex VI Part B point 22 of the MDR. |
4. Integration of the eIFU within the QMS
The solution system for hosting needs validation to show it works and keeps data safe. This involves a software validation approach by a risk-based approach per ISO 13485 (and/or ISO/TR 80002-2).
5. Why choose Matrix eIFU for your eIFU implementation ?
Matrix eIFU is a cloud based platform for hosting digital instructions for medical devices and drugs.
The system provides white label portals for a seamless experience. It includes modules for audit logs, change records, and an approval process to maintain data integrity.
The platform manages versioning with geo-fencing and website translations to align with local language needs. It also handles paper copy orders to meet the seven day deadline. The solution provides templates for all quality assurance processes including software and system validation reports.