EU Expands eIFU Eligibility: Key Changes under Implementing Regulation (EU) 2025/1234
The EU expands the use of electronic Instructions for Use (eIFU) for professional-use medical devices under Implementing Regulation (EU) 2025/1234. Key compliance considerations for MDR and IVDR manufacturers.
CEREGULATORY
eIFU for Professional-Use Devices: What Manufacturers Should Know
EU Expands the Use of Electronic Instructions for Use under Regulation (EU) 2025/1234
The European regulatory framework for electronic Instructions for Use, commonly known as eIFU, continues to move toward greater digitalisation.
With the adoption of Commission Implementing Regulation (EU) 2025/1234, the European Commission has expanded the categories of medical devices that may provide instructions for use in electronic format. This update amends Commission Implementing Regulation (EU) 2021/2226 and creates new opportunities for manufacturers to manage product documentation more efficiently.
For manufacturers of medical devices and in vitro diagnostic medical devices, this is an important development. It supports the shift toward digital documentation while preserving the safety principles required under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.
eIFU Remain Limited to Professional-Use Devices
One important principle remains unchanged: eIFU may only replace paper instructions where the device is intended exclusively for professional users.
Devices intended for lay users, home use, consumer healthcare settings, or self-testing environments must generally continue to be supplied with paper instructions.
Manufacturers should therefore assess their intended users carefully. The decision to use eIFU should be supported by the device’s intended purpose, user profile, foreseeable use environment, and documented risk management activities.
Regulatory Basis under MDR and IVDR
Both MDR and IVDR require manufacturers to provide information that is clear, understandable, accessible, and kept up to date throughout the product lifecycle.
Key regulatory references include:
• MDR Article 10(11) and Annex I, Chapter III, Section 23
• IVDR Article 10(10) and Annex I, Chapter III, Section 20
Manufacturers may also refer to EN ISO 20417:2021, which provides useful guidance on information supplied by the manufacturer for medical devices.
A Practical Benefit: Managing EU Language Requirements
One of the biggest operational advantages of eIFU is language management.
Under MDR and IVDR, instructions for use must be available in the official language or languages required by each EU Member State where the device is made available. For manufacturers selling across multiple European markets, this can result in many different translated IFU versions.
A compliant eIFU system can help manufacturers:
• host multiple language versions in one controlled location
• provide users with access to the correct language version
• update translations more efficiently without reprinting paper manuals
• reduce packaging complexity and printed documentation volume
For companies distributing across the EU, this can significantly simplify documentation control and reduce operational burden.
Operational Advantages of eIFU
Beyond language management, eIFU can bring several practical benefits for Regulatory Affairs, Quality, and Operations teams.
Faster Updates
Electronic instructions can be updated more quickly once the required regulatory and internal approvals are completed. This is especially useful when safety information, warnings, or procedural instructions need to be updated.
Better Document Control
A properly managed eIFU platform allows version control, traceability, publication history, and access to archived versions. This supports better lifecycle management of product information.
Sustainability and Logistics Efficiency
Reducing printed IFUs can help lower paper use, reduce packaging volume, simplify inventory management, and support sustainability objectives.
Key Compliance Requirements
The use of eIFU must be carefully controlled. Manufacturers cannot simply remove paper IFUs without meeting regulatory conditions.
Risk Assessment
Manufacturers must perform and document a risk assessment showing that providing the IFU electronically maintains or improves the level of safety compared with paper instructions.
This assessment should consider the intended users, use environment, access to internet or electronic systems, possible failure modes, and any risks associated with delayed access to instructions.
Availability and Accessibility
eIFU should be available in all EU Member States where the device is placed on the market, unless a justified limitation is supported by the risk assessment.
The eIFU must be accessible through a website or electronic medium and provided in a commonly used format that can be opened using freely available software.
Website Requirements
If a website is used to host eIFU, it should be secure, stable, and reliable. Manufacturers should ensure that the website is protected against unauthorised access, tampering, excessive downtime, and data protection risks.
The internet address should be stable, direct, and easy for users to access.
Paper IFU Upon Request
Even where eIFU are used, manufacturers must have a process to provide a paper version upon request at no additional cost. This should normally be provided within 7 calendar days.
This process should be clearly defined and communicated to users.
Labelling Requirements
The device label or packaging must clearly indicate that the instructions for use are provided electronically. It must also explain how users can access the eIFU.
The access information should be clear, practical, and suitable for the intended professional user.
Retention and Version History
Manufacturers must retain eIFU electronically for the required period after the device is last placed on the market.
Generally, retention periods are:
• 10 years for devices with a defined expiry date, except implantable devices
• 15 years for implantable devices or devices without a defined expiry date
Historical versions, including their publication dates, should remain accessible on the website or be made available upon request if they are no longer publicly displayed.
Link to UDI and Eudamed
Once registration in Eudamed’s UDI database becomes mandatory, manufacturers will need to provide the internet address where the eIFU can be accessed.
This creates a stronger link between device identification, regulatory databases, and digital product information.
Manufacturers should therefore ensure that their eIFU URLs are stable, controlled, and aligned with their UDI and regulatory data management processes.
What Manufacturers Should Do Now
Manufacturers considering eIFU should review whether their devices are eligible, especially whether they are intended exclusively for professional users.
They should also prepare:
• a documented eIFU risk assessment
• a controlled eIFU hosting process
• multilingual IFU management procedures
• a system for paper IFU requests
• version control and retention processes
• labelling updates indicating electronic access
• internal responsibilities for eIFU maintenance
Conclusion
The updated EU eIFU framework creates useful opportunities for professional-use medical device and IVD manufacturers. When implemented correctly, eIFU can improve documentation control, simplify multilingual compliance, reduce printing burden, and support faster updates across the European market.
However, eIFU must be implemented carefully. The ability to replace paper instructions remains limited to devices intended exclusively for professional users, and manufacturers must maintain clear evidence that electronic delivery does not compromise safety.
For manufacturers entering or expanding in Europe, eIFU can be a valuable part of a modern regulatory and documentation strategy — provided the system is properly justified, controlled, and maintained.