Publication in the OJEU of Implementing Regulation (EU) 2025/1234 on electronic instructions for use

The European Commission has just published Implementing Regulation (EU) 2025/1234, amending Regulation (EU) 2021/2226 on electronic instructions for use (eIFU).

This text now extends the possibility of providing eIFUs to all medical devices intended for professional use, including those without a medical purpose (Annex XVI of the MDR).

Some key points:

• Healthcare professionals have expressed a clear preference for the electronic format (results of the consultation conducted in 2024).
• Manufacturers must still provide IFUs in paper format when use by the general public is reasonably foreseeable.
• The internet address of eIFUs will have to be integrated into Eudamed via the UDI database, the latest at the time of mandatory registration of devices in the database.

This regulation aims to enhance flexibility, speed up access to information, and reduce the environmental impact associated with the systematic printing of instruction for use.

Entry into force: 20 days after publication in the OJEU, i.e. July 16, 2025.

DOWNLOAD THE REGULATION (EU) 2025/1234