Briefing
eIFU: The Device Manual Just Became a Regulated System
The Change
Paper Optional, Obligations Not
The EU has allowed electronic IFUs for a narrow device set since Implementing Regulation 2021/2226. The 2025 amendment — Regulation 2025/1234, in force since July — blows the scope open: nearly all professional-use devices, accessories and Annex XVI products included, may now ship electronic-only instructions. (Devices serving both professionals and lay users keep paper.) The conditions are where the story lives: a documented risk assessment including users' technology access; an eIFU system that is secure, accessible, and kept up to date; and paper free of charge within seven days of any request.
Read those conditions as an engineer and the conclusion is immediate: a PDF exported to the website satisfies none of them durably. The regulation quietly requires what this site calls a content services platform — it just doesn't use the words.
The Familiar Shape
We've Built This Machine Before
Map the eIFU conditions to machinery and every clause lands on something regulated publishing already knows. Kept up to date, with history that answers audits: that's version supersession with time attached. Secure and appropriately scoped: the permission model controlled documents always need. Provable delivery — who was served which revision, when: the event capture we argue for on every estate. The seven-day paper fallback: an operational trigger wired to a rendering pipeline that can produce a current, accessible print copy on demand. Even the accessibility thread joins up — structured source content passes both regimes at once.
For device manufacturers, the strategic read: the regulation just made your documentation infrastructure a compliance asset or a compliance gap, permanently — and the manufacturers who build the platform version now will meet every subsequent rule (and market) from infrastructure instead of scramble. For our regular readers, the meta-note: this is the same machine, wearing a CE mark. That's precisely why we're at home in it.
FAQ
Questions We Hear
What changed, and when?
The EU has permitted electronic instructions for use for a narrow set of devices since Implementing Regulation (EU) 2021/2226 took effect in January 2022. The step change is Implementing Regulation (EU) 2025/1234, in force since July 2025: it expands eIFU eligibility to nearly all medical devices intended for professional use — accessories and the MDR's Annex XVI products included. Devices intended for both professional and lay users still require paper. In short: for the professional-use market, the paper IFU just became optional — and the electronic one became a regulated obligation.
What conditions come attached to going electronic?
The ones that turn a document into a system. A documented risk assessment covering, among other things, users' access to technology and scenarios where paper is still needed. An eIFU system that is secure, accessible, and kept up to date — with the version question ('which IFU revision applied to this device, on this date') implicitly auditable. And a paper fallback: a printed copy provided free of charge within seven days of a user's request. None of that is satisfied by exporting a PDF to the website; all of it is satisfied by the delivery architecture regulated publishing already uses.
Why does a technical publications consultancy care about medical devices?
Because the eIFU requirements are, almost clause for clause, the machinery we build for other regulated publishers: one governed source of truth, version supersession with history retained, permission and audience scoping, delivery that's fast and available, an audit trail answering who was served which revision when, and accessibility as a property of the structure rather than a remediation pass. Medical devices are a new label on a problem this practice has been solving for years — which is exactly why we're writing about it.
What should a manufacturer moving to eIFU actually build?
Resist the minimal reading — a PDF on a product page — because the conditions outlast it: revisions accumulate, the risk assessment needs the system's properties to lean on, and the seven-day paper obligation needs an operational trigger. The durable shape is a delivery platform treating each IFU as a versioned publication: current revision unambiguous, superseded ones retained and addressable, per-device or per-market scoping, usage events captured, and the content structured so accessibility and translations are outputs rather than projects. Build it once and the next regulation lands on infrastructure instead of on scramble.
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An IFU System, Not an IFU File
If your eIFU plan is a PDF on the product page, the conditions will outgrow it. We build the versioned, auditable, paper-on-demand delivery machine the regulation actually describes.