Blog · 14 July 2026

Regulation (EU) 2025/1234: eIFU is now an option for all professional-use medical devices

Until recently, EU law allowed electronic instructions for use (eIFU) only for a narrow group of medical devices. That changed on 16 July 2025: Commission Implementing Regulation (EU) 2025/1234, which amends Implementing Regulation (EU) 2021/2226, extends the option to provide instructions for use in electronic form instead of paper to all medical devices intended for professional users.

What changed

Under the original Regulation (EU) 2021/2226, eIFU was limited mainly to implantable and fixed installed devices and devices fitted with a built-in system for displaying the instructions. Regulation (EU) 2025/1234 removes this category restriction. If your device is intended exclusively for use by healthcare professionals, you may now provide its instructions for use in electronic form only.

• eIFU is allowed for all medical devices intended for professional use, regardless of device class or category.
• The option also covers products without an intended medical purpose listed in Annex XVI of the MDR, when intended for professional users.
• It applies to legacy devices placed on the market under the MDR transitional provisions as well.

What stays the same

The safeguards of Regulation (EU) 2021/2226 continue to apply. Before switching to eIFU, the manufacturer must carry out a documented risk assessment demonstrating that providing the instructions electronically maintains or improves the level of safety. Users must be informed how to access the instructions, and a paper copy must be provided on request at no additional cost. The electronic instructions must be available on the manufacturer's website in a commonly used format, kept up to date and accessible for the required period after the last device has been placed on the market.

Devices intended for lay users are not covered — paper instructions remain mandatory for consumers. For devices intended for both professionals and lay users, the information intended for the consumer must still be provided on paper.

One EU regulation, different national practice

As an implementing regulation, 2025/1234 applies directly in every EU member state from the same date — but the practical rollout differs country by country. In Czechia, the competent authority SÚKL published guidance and lets manufacturers reference the eIFU URL in the national RZPRO registry until EUDAMED registration is available. In Germany, no separate national notification route exists — the regulation applies without an additional transposition act, with industry guidance provided by BVMed and BfArM as the competent federal authority. Manufacturers selling across several markets should therefore check the expectations of each national authority, not just the EU text.

Why this matters for manufacturers

For most manufacturers of professional-use devices this is a direct opportunity to cut printing, packaging and distribution costs and to update safety information within hours instead of months. It also removes a frequent source of nonconformities: outdated paper manuals circulating in the field. The market is moving — competitors who adopt eIFU first will ship leaner packages and react faster to regulatory changes.

How to make the switch compliant

• Perform and document the risk assessment required by Regulation (EU) 2021/2226.
• Publish the instructions on a reliable, secured website with guaranteed availability, in a widely used format.
• State clearly on the label or packaging how the eIFU can be accessed (URL, and where applicable the UDI or REF code).
• Set up a process for providing a paper copy on request without additional cost.
• Keep all published versions traceable and archived for the required retention period.

An eIFU platform such as DocuLiv covers the technical side of these obligations out of the box: a secured, highly available portal, document access via REF or UDI code, version management and multilingual publication.