---
title: Electronic Instructions for Use (eIFU) Under MDR: Going Digital
description: When you can replace a paper IFU with an eIFU under MDR and Regulation (EU) 2021/2226: eligible devices, website rules, and paper-on-request.
authors: Tibor Zechmeister, Felix Lenhard
category: Technical Documentation & Labeling
primary_keyword: eIFU MDR electronic instructions for use
canonical_url: https://zechmeister-solutions.com/en/blog/electronic-instructions-for-use-eifu-mdr
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Electronic Instructions for Use (eIFU) Under MDR: Going Digital

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **eIFU under MDR means providing the instructions for use in electronic form instead of on paper, and it is permitted only under the conditions of Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234. eIFU is restricted to specific device categories used by professional users, requires a documented risk assessment, a compliant website carrying every required particular, labelling that tells the user the IFU is electronic, and the ability to supply a paper IFU on request at no additional cost. eIFU is not "no IFU" — the full IFU still exists; only the delivery medium changes.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- eIFU is governed by Commission Implementing Regulation (EU) 2021/2226, as amended by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025. The MDR itself (Regulation (EU) 2017/745, Annex I, Chapter III, Section 23) sets the baseline IFU obligation; 2021/2226 is the implementing act that allows the electronic form.
- eIFU eligibility is limited to specific categories — in broad terms, implantable and active implantable devices intended exclusively for professional users, fixed installed devices, and devices with built-in systems that display the IFU. Consumer and lay-user devices are generally excluded. 
- The manufacturer must perform and document a specific risk assessment before switching a device to eIFU — covering user knowledge, use environment, access to the electronic version, and contingency if access fails.
- The eIFU website must be publicly available, list the IFU in every required Member State language, provide current and superseded versions, and function without requiring registration, passwords, or payment.
- The label must indicate that the IFU is supplied in electronic form and tell the user how to access it. The time period during which the eIFU must remain available after the last device is placed on the market is set in the Implementing Regulation. 
- A paper IFU must be supplied on request, free of charge, within the time window set by the Regulation, to any user who asks for one. 
- eIFU is a delivery mechanism, not an exemption. The content obligations of MDR Annex I Section 23.4 remain in full. This is different from the Section 23.1(d) exception described in [when an IFU is not required under MDR](/blog/when-ifu-not-required-mdr).

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## Why founders ask about going digital

The question comes up the moment a founder starts costing out the IFU for a Class IIb or Class III device. Twenty-four EU languages. A fifty-page document with diagrams. Translation validation. Document control. A printing line that has to be revalidated whenever the file changes. The founder multiplies the numbers, then asks the obvious question: can we just put the IFU on a website?

The honest answer is: sometimes yes, under strict conditions, for a limited set of device categories, and only after a documented risk assessment that lives in the technical file. Commission Implementing Regulation (EU) 2021/2226 is the instrument that allows it. The scope is narrower than most founders hope, the compliance obligations are real, and the paper-on-request backstop means the paper pipeline never fully disappears. For the right device, eIFU is a meaningful subtraction. For the wrong device, claiming eIFU produces a file that fails at audit and a label that misleads the user.

## The legal stack

eIFU sits on top of the MDR IFU obligation, not to one side of it. The MDR requires an IFU for every device that is not covered by the narrow Section 23.1(d) exception; see [when an IFU is not required under MDR](/blog/when-ifu-not-required-mdr) for that carve-out. The content of the IFU is fixed by Annex I, Chapter III, Section 23.4. (Regulation (EU) 2017/745, Annex I, Chapter III, Section 23.)

Article 10 of the MDR is the general manufacturer obligations article. Article 10(11) requires that information supplied with the device be provided in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. That language obligation flows through to eIFU: electronic form does not mean English-only. (Regulation (EU) 2017/745, Article 10(11).)

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 lays down the rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices. It sets out the eligible device categories, the mandatory risk assessment, the website requirements, the labelling duties, the retention period, and the paper-on-request obligation. It was amended by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025, which updates certain scope and timing provisions. 

The net effect: eIFU is a permission granted by a specific instrument, under specific conditions, for specific devices. Outside those conditions, an IFU must still be supplied on paper with the device.

## Eligibility: which devices can use eIFU

Commission Implementing Regulation (EU) 2021/2226 restricts eIFU to specific device categories. In broad terms, the eligible categories include:

- **Implantable and active implantable medical devices intended exclusively for the implantation or programming of the device by a healthcare professional.** The rationale: the professional receiving the device is trained, works in a structured environment, and has reliable access to the electronic version.
- **Fixed installed medical devices** — devices installed and used at a fixed location, typically in a clinical facility, where the eIFU can be accessed from a workstation in that environment.
- **Medical devices with a built-in system that visually displays the instructions for use** — devices whose user interface itself presents the IFU on demand.
- **Software as a medical device (standalone software)** — where the IFU can be presented through the software itself.
- **Accessories to the above categories**, where the accessory is used in the same professional environment.

Devices intended for use by lay users — patients, carers, home users — are generally excluded from eIFU and must continue to travel with a paper IFU. The underlying logic is that a lay user cannot be assumed to have reliable access to a website, an account, or the digital literacy to retrieve and read an eIFU in the moment of use. 

For the companion piece on when an IFU is required at all and what Section 23.4 demands of the content itself, see [the instructions for use under MDR](/blog/instructions-for-use-mdr-compliant) and [MDR labeling requirements](/blog/mdr-labeling-requirements).

## The mandatory risk assessment

Before a manufacturer can switch a device to eIFU, Commission Implementing Regulation (EU) 2021/2226 requires a specific, documented risk assessment. This is not an abstract risk-file update. It is a targeted analysis that lives in the technical documentation and answers a set of specific questions about the eIFU route itself.

**Knowledge and experience of intended users.** Does the intended user — as defined in the use specification under EN 62366-1:2015+A1:2020 — have the knowledge and experience to retrieve, display, and use an electronic IFU? For a professional hospital user this is straightforward. For anyone else, the answer is usually no.

**The environment in which the device is used.** Is the use environment reliably connected, equipped, and organised such that a professional user can access the eIFU when they need it? A clinical facility with networked workstations passes; a remote or emergency environment typically does not.

**Access to the electronic IFU.** Can the user actually reach the eIFU when needed — including when the device is being set up for the first time, when a question arises during use, and when something goes wrong? Access that depends on a phone with a signal that might not exist is not reliable access.

**Contingency if access fails.** What happens if the website is down, the user's network is down, or the user cannot find the IFU? The contingency must be real, documented, and consistent with the paper-on-request obligation.

**Cybersecurity and integrity.** The website must be protected against tampering, the version served must match the version released, and the integrity of the content must be auditable.

The conclusion of the risk assessment is an explicit statement that the device meets the conditions of Commission Implementing Regulation (EU) 2021/2226 and that eIFU is an appropriate delivery route. Without that documented conclusion, the file is not ready.

## Website requirements

The eIFU website is a regulated artefact. Commission Implementing Regulation (EU) 2021/2226 sets out its obligations.

**Public availability.** The website must be publicly accessible. Registration, passwords, and paywalls are incompatible with the obligation. A user who has the device should be able to reach the IFU without credentials.

**All required languages.** Every language that the Member States where the device is made available require under Article 10(11) must be present. "English only" is not compliant for a device placed on the market in France, Germany, or Italy.

**Current and superseded versions.** The current version must be clearly identified. Superseded versions must remain available for the retention period set by the Implementing Regulation, so that a user or an authority can consult the version that was in force at the time a specific device was used. Version control and timestamping are mandatory.

**Date of issue and identification.** Every IFU version on the site must carry a date of issue and a clear identification of the device or device family to which it applies.

**Integrity and availability.** The website must be protected against unauthorised modification. Downtime must be rare and monitored. The content that is served must match the content that was released.

**Printable format.** The user must be able to download and print the IFU if they want to. PDF or a comparable print-stable format is the usual solution.

**Retention period.** The eIFU must remain available for a defined minimum period after the last device is placed on the market. 

The website is part of the regulatory obligation, not a marketing site with a PDF link. Hosting it on a subdomain with a dedicated maintenance process is the normal pattern.

## Labelling and paper-on-request

The label on the device and its packaging must indicate clearly that the IFU is supplied in electronic form instead of on paper, and must tell the user where and how to access it — typically through a URL, a QR code, or both. The indication must be unambiguous so that a user unpacking the device does not mistake the absence of a paper booklet for a missing document.

Alongside the eIFU, the manufacturer must supply a paper IFU to any user who requests one, free of charge, within the time window set by the Implementing Regulation.  Paper-on-request means the paper IFU pipeline never fully disappears. It is scaled down — printed on demand rather than shipped with every unit — but the translation, document control, and print process still have to be in place.

The practical implication: eIFU removes the per-unit printing and shipping cost of the IFU, but it does not remove the obligation to maintain a compliant paper IFU. The economics only work when the per-unit saving is large relative to the fixed cost of running a compliant eIFU website and a paper-on-request service.

## Test: is your device eligible or not?

**Likely eligible:** A Class IIb fixed-installed imaging workstation used exclusively in radiology departments, by trained radiographers, with a known professional use environment and networked access at every installation site. The eIFU website carries the current and superseded IFUs in all required languages; the label carries a QR code and a URL; paper-on-request is handled by the service team.

**Likely eligible:** An implantable pulse generator programmed exclusively by cardiologists in specialist clinics. The IFU is accessed by the implanting physician through a professional portal; the website carries all required language versions; paper-on-request is honoured within the regulatory time window.

**Likely eligible:** A software-only medical device where the IFU is presented through the software's own help system, with a downloadable PDF version available from the product website.

**Likely not eligible:** A home-use blood pressure monitor sold to patients through pharmacies. Lay user, home environment, unreliable access. eIFU is not an option; a paper IFU must ship with every unit.

**Likely not eligible:** A Class IIa self-test kit used by patients at home. Lay user, critical interpretation of results, time-sensitive use. Paper IFU required.

**Likely not eligible:** A Class III implant whose intended users include non-specialist clinicians in unstructured environments without reliable network access at the point of use. The risk assessment would not support the switch.

The test is not "do I want the subtraction?" It is "does Commission Implementing Regulation (EU) 2021/2226 say this device category qualifies, and can I defend the risk assessment?"

## Ship: an eIFU rollout playbook

For a manufacturer with an eligible device and the intention to go digital, the rollout sequence is:

1. **Confirm eligibility** against Article 3 of Commission Implementing Regulation (EU) 2021/2226 as amended. If there is any doubt, escalate to a Notified Body pre-submission query rather than assuming.
2. **Write the specific eIFU risk assessment** described above. Route it through the QMS risk management process and the usability file. Get it signed off by the person responsible for regulatory compliance under Article 15 of the MDR.
3. **Build or commission the eIFU website.** Treat it as a regulated artefact with change control, uptime monitoring, version management, and backup. Host on a stable subdomain. Document the operational procedures.
4. **Prepare the label change.** Add the indication that the IFU is electronic and the access information (URL, QR code). Validate the label change through the QMS change control process. Check the visibility and scannability of the QR code on the actual packaging.
5. **Set up the paper-on-request process.** A request channel (email, phone, web form), a fulfilment workflow, a printer pipeline, and a time-window tracker that guarantees delivery within the regulatory window. Assign ownership.
6. **Translate and load all required language versions** into the website. Validate the load against the release controlled copies.
7. **Pre-notify the Notified Body** of the change for devices under NB oversight, and update the technical documentation. For Class I self-certified devices, update the TD and hold it ready for competent authority inspection.
8. **Monitor and maintain.** Website uptime, paper-on-request SLA compliance, user complaints about access. These become PMS inputs under MDR Article 83 and flow into the next PMS report.

The rollout is a project, not a one-week task. For a first eIFU, budget several months from decision to go-live.

## Reality Check — Where do you stand?

1. Is your device in one of the eligible categories under Article 3 of Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234?
2. Is the intended user exclusively a trained professional, and is the intended use environment reliably equipped to access an electronic IFU?
3. Have you performed and documented the specific eIFU risk assessment required by the Implementing Regulation, signed off by the PRRC?
4. Does your eIFU website plan cover public access, all required languages, current and superseded versions, integrity, and the retention period after last device placed on the market?
5. Does your label plan include the indication that the IFU is electronic and an unambiguous access mechanism (URL and/or QR code)?
6. Do you have a paper-on-request process that can deliver a printed IFU free of charge within the time window set by the Regulation?
7. Are you clear that eIFU is a delivery mechanism, not a content exemption — every Section 23.4 requirement still applies?

## Frequently Asked Questions

**What is an eIFU under MDR?**
An eIFU is the instructions for use of a medical device supplied in electronic form instead of on paper. Under the MDR, eIFU is governed by Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234. The content obligations from MDR Annex I, Chapter III, Section 23.4 still apply in full; only the delivery medium changes.

**Which devices are eligible for eIFU?**
Broadly, implantable and active implantable devices intended exclusively for professional users, fixed installed devices in professional environments, devices with built-in systems that display the IFU, and standalone software medical devices. Consumer and lay-user devices are generally excluded. The exact eligible categories are set out in Article 3 of Commission Implementing Regulation (EU) 2021/2226 as amended.

**Can I provide an eIFU for a home-use device?**
Generally no. Devices intended for lay users — patients, carers, home users — are excluded from eIFU under Commission Implementing Regulation (EU) 2021/2226, because the risk assessment cannot reasonably conclude that a lay user has reliable access to and capability with electronic documents at the moment of use. A paper IFU must accompany the device.

**Do I still have to provide a paper IFU if I switch to eIFU?**
Yes, on request. The Implementing Regulation obliges the manufacturer to supply a paper IFU free of charge, within a defined time window, to any user who asks for one. The paper pipeline is scaled down but not eliminated. Translation, document control, and print readiness all still have to be maintained.

**Does the eIFU website need to support every EU language?**
It must support every official language required by the Member States where the device is made available, in line with Article 10(11) of the MDR. In practice that usually means most or all of the 24 official EU languages for a device placed on the market across the EU. English-only is not compliant for a device sold in France, Germany, or Italy.

**What happens if the eIFU website goes down?**
Downtime has to be rare and monitored, and the manufacturer must have contingency. The paper-on-request backstop is part of the answer: a user who cannot reach the website can always request a paper copy. Prolonged or frequent outages are a compliance failure and a PMS signal.

**Is eIFU the same as "no IFU"?**
No. eIFU replaces the paper IFU with an electronic one; the IFU still exists and still meets Section 23.4 in full. The separate narrow exception in MDR Annex I, Chapter III, Section 23.1(d) — covered in [when an IFU is not required under MDR](/blog/when-ifu-not-required-mdr) — allows the IFU to be omitted altogether for eligible Class I and Class IIa devices that can be used safely and as intended without any instructions. They are two different mechanisms and should never be combined.

## Related reading

- [The Instructions for Use (IFU) Under MDR: How to Write Compliant IFUs](/blog/instructions-for-use-mdr-compliant) — the content obligations under Annex I Section 23.4 that eIFU does not change.
- [When an IFU Is Not Required Under MDR: Class I Exceptions](/blog/when-ifu-not-required-mdr) — the narrow Section 23.1(d) exception, which is distinct from eIFU.
- [MDR Labeling Requirements: What Must Appear on Your Device Label](/blog/mdr-labeling-requirements) — the label particulars that survive under any IFU delivery mode, plus the eIFU indication.
- [MDR Annex I Chapter III: Information Supplied with the Device](/blog/mdr-annex-i-chapter-iii-information-supplied) — the full Section 23 structure that sits above the eIFU rules.
- [Common Labelling Mistakes Startups Make Under MDR](/blog/common-labeling-mistakes-startups-mdr) — recurring failures that include misunderstood eIFU routes.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Annex I, Chapter III, Section 23 (information supplied with the device), and Article 10(11) (language obligations). Official Journal L 117, 5.5.2017.
2. Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices. Official Journal L 448, 15.12.2021.
3. Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Commission Implementing Regulation (EU) 2021/2226.

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*This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. eIFU is a real subtraction for the right device in the right environment — but it is a delivery mechanism, not a content exemption, and the paper pipeline never fully disappears.*

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*This post is part of the [Technical Documentation & Labeling](https://zechmeister-solutions.com/en/blog/category/technical-documentation) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*