Expanded eIFU Eligibility under EU Regulation 2025/1234

Written by QbD Group | Jul 3, 2025 1:00:00 PM

Expanded rules for electronic instructions for use (eIFUs)

Effective: Published June 27th, entering into force 20 days later
Amends: Commission Implementing Regulation (EU) 2025/1234
Purpose: To broaden the scope of devices eligible to provide IFUs in electronic form instead of paper.

What changed?

The EU now allows all medical devices and their accessories intended for professional users to provide electronic Instructions for Use (eIFUs). This means the scope is no longer limited to devices like (active) implantables, fixed installed medical devices, and devices with a built-in system for visually displaying instructions. This change responds to industry demand and digital transformation trends.

Below you’ll find the key highlights of the regulation, or you can consult the document of the Official Journal of the European Union.

Key highlights

How you can take advantage of the updated regulation

You can now:

Replace printed IFUs for a much wider range of devices
Digitize documentation workflows, reducing costs
Improve update speed and support sustainability goals. But you must still meet strict EU MDR/IVDR requirements regarding the IFU for content, delivery, labeling, and traceability.

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