Electronic Instructions for Use (eIFU)

When may instructions for use be electronic in the EU?

Regulation (EU) 2021/2226, as amended, permits electronic instructions for MDR-covered devices and accessories intended for professional users. Regulation (EU) 2025/1234 expanded the former device-category limits to this broader professional-use scope, including qualifying legacy and Annex XVI products. If it is reasonably foreseeable that a professional-use device will also be used by lay persons, the instructions intended for lay users must still be supplied in paper form.

What conditions attach to eIFU?

The manufacturer must document a risk assessment and meet detailed controls for access, availability, versioning and website presentation. Users must be told how to access the instructions, and a paper copy must be available on request without additional cost within the timeframe set by the regulation. The electronic instructions must be provided in the Union language or languages determined by the Member State where the device is made available; that is more precise than assuming every official EU language is required in every market.

Why do manufacturers adopt eIFU?

Electronic delivery can reduce printing and inventory complexity and make controlled versions easier to distribute across a professional-use portfolio. It does not eliminate labeling governance. A manufacturer still needs to link the correct instructions to the correct device and software version, preserve earlier versions where required, validate publication controls and ensure continued access during foreseeable website or service disruption. A changed IFU may also require the same regulatory change assessment as its paper equivalent.

Is eIFU a global concept?

Yes, but the permission is jurisdiction-specific. Other markets define different eligible devices, user groups, paper-on-request rules, language requirements and retention periods. A global labeling platform can reuse controlled source content, while release rules determine whether each market receives electronic instructions, paper instructions or both. The European Union market page places the current EU permission within the wider MDR labeling obligations.