An electronic IFU still owes seven days of paper

A device team that hears ‘electronic instructions for use are now allowed’ often reads that as permission to drop the paper insert and point users to a PDF online. EU Implementing Regulation 2021/2226 doesn't grant that permission generally, and the 2025 amendment that broadened its reach still didn't grant it without conditions. The regulation opens a door for devices intended for professional use, gated behind a documented risk assessment the manufacturer has to complete and keep current, and even a device that clears every condition still owes any user who asks a paper copy within seven calendar days, free of charge. Electronic instructions for use replace the default delivery method for the devices the regulation actually covers. They don't replace the underlying obligation to make the same content available on paper when someone needs it that way.

The door widened in 2025, but it's still a professional-use door

The original 2021/2226 text opened electronic instructions for use to a short, named list of device categories: implantable and active implantable devices, fixed-installed devices and their accessories, and devices built with their own display capable of showing the instructions on-screen — all restricted to professional-use settings. Commission Implementing Regulation 2025/1234, in force since July 16, 2025, widened that list considerably: it extends eligibility to essentially any device intended for professional use, including the non-medical devices MDR Annex XVI covers, and to accessories as well as the devices they accompany. What the amendment didn't touch is the boundary around lay use. A device used by both a professional and a patient still owes that patient a paper copy; the electronic route only ever replaces paper for the professional-use population the device is actually cleared to reach.

The risk assessment is the gate, not a formality behind it

A manufacturer doesn't opt into electronic instructions by simply falling inside an eligible category. The regulation conditions the choice on a documented risk assessment demonstrating that the level of safety the electronic version provides is equal to or better than paper would provide for the same device — covering, at minimum, the intended users' knowledge and experience, the characteristics of the environment the device will actually be used in, and the users' own familiarity with the hardware and software needed to display the instructions in the first place. A manufacturer that checks the device against the eligible-category list and stops there has cleared the threshold question without doing the assessment the regulation actually requires before that threshold converts into a decision.

Paper doesn't disappear — it becomes a seven-day promise

Every manufacturer relying on the electronic route has to keep a system in place to provide the paper version to any user who asks, free of charge, within seven calendar days of the request. That's a standing operational commitment, not a one-time exception: it has to work correctly on the day a user calls, potentially years after the device shipped, and it applies regardless of how confident the original risk assessment was that electronic delivery matched paper's safety level. A team that budgets for the electronic-delivery infrastructure and never builds the fulfillment path for that seven-day promise has implemented half the regulation.

The label still has to say what it did

A device relying on electronic instructions has to say so on its own labeling — for software, at the point where access to the software itself is granted — so a user encountering the device for the first time knows the paper insert they might expect isn't coming with the box. And the electronic version itself doesn't get to disappear once it's posted: for a device with its own expiration date, other than an implant, the regulation requires the instructions to stay available for ten years after the last device covered by that version was placed on the market, and for at least two years past that last device's own expiration date, whichever runs longer. A website that gets quietly taken down once a product line is discontinued is closing an obligation the regulation keeps open well past the device's own shelf life.

Where this meets the rest of the file

The content test electronic delivery doesn't touch at all is the one Annex I Section 23.4 already sets for what the instructions have to say, regardless of the medium carrying them — a manufacturer that clears the electronic-delivery conditions still owes the same completeness the content test requires on paper. And the risk assessment 2021/2226 requires is a targeted, delivery-specific instance of the same reasoning a risk management file already has to apply hazard by hazard — a separate document, not a substitute for the file it sits beside.

An electronic-IFU eligibility and risk-assessment worksheet built around this structure — the professional-use eligibility test, the seven-day paper commitment, and the availability-duration clock — is previewed in the launch catalog. If your program's eligibility determination runs differently, the shelf takes that correction directly.