Is eIFU legal? The 2026 status of electronic instructions for use, market by market

Electronic instructions for use (eIFU) are legal today for the large majority of professional-use medical devices in the European Union, the United Kingdom, Switzerland, the United States, Canada, Australia, Brazil, Saudi Arabia and Japan. The rules differ in the details, but they share one shape: eIFU is permitted for devices used by healthcare professionals, paper remains mandatory for devices used by lay persons, and every manufacturer must be able to send a printed copy on request. This article reviews the legal status of an eIFU implementation market by market, with the primary references at the end, as of November 2026.

What "eIFU" means in law

In regulatory texts, electronic instructions for use means instructions provided instead of paper: on a website, on electronic media supplied with the device, or on a display built into the device. Supplementary digital content (a QR code that leads to a video, an app, a PDF that duplicates the paper IFU) is not an eIFU in the legal sense and does not need a specific permission. What needs permission is the decision to stop putting paper in the box. That is the decision this article is about.

European Union: medical devices (MDR)

Legal basis. Regulation (EU) 2017/745 (MDR), Annex I, section 23.1(f), allows instructions for use to be provided in non-paper form under the conditions set by an implementing act. That act is Commission Implementing Regulation (EU) 2021/2226, in application since 4 January 2022 and amended by Commission Implementing Regulation (EU) 2025/1234, in force since 16 July 2025 [1][2].

Which devices. Until July 2025, eIFU was limited to implantable devices, fixed installed devices, devices with a built-in display and their accessories. Regulation 2025/1234 removed that list. Article 3(1) of the amended regulation now allows eIFU for all devices covered by Article 1(4) MDR that are intended for professional users: every class of medical device, their accessories and the Annex XVI products without an intended medical purpose. Recital 3 confirms that legacy devices under the Article 120 transitional provisions are included [2][3].

The lay-user rule. Article 3(2) is the one line that still forces paper: where it is reasonably foreseeable that a professional-use device will also be used by lay persons, the instructions intended for lay persons must be provided in paper form. Home-use devices stay on paper.

Conditions that still apply. The amendment did not relax the operating conditions of 2021/2226, which are the basis of any eIFU platform:

• A documented risk assessment before going electronic, covering the users' knowledge and experience, foreseeable emergency situations that require paper, and the impact of the website or the internet being temporarily unavailable (Article 4).
• A system that delivers a paper copy free of charge within 7 calendar days of a request (Article 5(3)).
• Electronic instructions kept available for 10 years after the last device is placed on the market (and at least 2 years after the expiry of the last device produced), or 15 years for implantables and devices without an expiry date (Article 5(9) and (10)).
• A clear indication on the label that the instructions are supplied in electronic form, with information on how to access them and how to request paper (Article 6). ISO 15223-1:2021 provides the symbol.
• A website that is protected against intrusion and tampering, designed to minimise downtime and display errors, GDPR-compliant, with a stable address, documents in a commonly used format readable with free software, and all previous versions with their publication dates (Article 7(2)).
• New in 2025/1234: the internet address of the eIFU must be submitted to the Eudamed UDI database (Article 7(3)), from the date device registration becomes mandatory under Article 123(3)(d) and (e) MDR. With the Eudamed UDI/Device module mandatory since 28 May 2026 and legacy devices to be registered by 28 November 2026, this is now a live obligation [4].

European Union: in vitro diagnostics (IVDR)

Regulation (EU) 2017/746 (IVDR) does not have an implementing regulation on eIFU and Regulation 2021/2226 does not apply to IVDs. The rule sits directly in Annex I, section 20.1(f): instructions for use may be provided in non-paper form for devices intended for professional use only, except devices intended for near-patient testing. Self-testing devices, which are by definition not professional-use, remain on paper [5]. We argued in January that the near-patient exclusion no longer matches clinical practice (see our earlier post); as of November 2026 the text is unchanged.

Switzerland

Switzerland applies the EU implementing regulations directly. Under Article 95 of the Medical Devices Ordinance (MedDO, SR 812.213), Swissmedic adopted Regulation 2021/2226 as amended by 2025/1234 with immediate effect on 8 August 2025, so the same scope (all professional-use devices, including legacy devices) and the same conditions apply in Switzerland, including the obligation to record the eIFU address in the UDI database [6].

United Kingdom

Great Britain. The UK Medical Devices Regulations 2002 (UK MDR 2002), regulation 4J, carry forward the pre-2021 EU scope: eIFU is permitted for active implantable and implantable devices, fixed installed devices, devices with a built-in display of the instructions, and standalone software, for professional users only and subject to a risk assessment and paper on request. The 2025 EU extension to all professional-use devices has not been mirrored in Great Britain. IVDs follow MEDDEV 2.14/3 rev.1. The MHRA guidance on eIFU remains the reference; the wider reform of the pre-market regulations is in draft and should be watched for a change of scope [7].

Northern Ireland. EU MDR and IVDR continue to apply under the Windsor Framework, so Regulation 2021/2226 as amended by 2025/1234 applies to devices placed on the Northern Ireland market.

United States

The Federal Food, Drug, and Cosmetic Act, section 502(f), as amended by section 206 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), allows the labelling of prescription devices intended for use in health care facilities to be provided solely by electronic means, provided that the labelling complies with all applicable requirements and that the user can request paper labelling, which must be provided promptly and at no additional cost. The Medical Devices Technical Corrections Act of 2004 (MDTCA) widened the provision: electronic labelling is now also allowed for prescription devices used by a health care professional regardless of the setting, for in vitro diagnostic devices used by health care professionals and for IVDs used in blood establishments. Over-the-counter devices and prescription devices used at home by lay persons remain on paper [16]. FDA's implementing memo adds that the conversion from paper to electronic does not by itself require a PMA supplement or a new 510(k), that verification and validation of the electronic labelling belong in the design history file, and that submissions must identify the website and confirm that its content is identical to the paper version. The content requirements of 21 CFR Part 801 (devices) and Part 809 (IVDs) continue to apply [8][9].

Canada

The Medical Devices Regulations (SOR/98-282), section 21(2), allow the information required by section 21(1), including the directions for use, to be provided electronically for devices that are not sold to the general public. Health Canada's labelling guidance specifies that the electronic label or the web address must accompany the device at the time of sale or delivery, that the electronic content must be identical to the paper version (an attestation letter from a senior official is suggested), and that a paper copy must be supplied as soon as possible on request. Devices sold to the general public fall under sections 22 and 23: directions for use on or in the package, in both official languages [10].

Australia

The Therapeutic Goods Administration permits eIFU for medical devices that are not supplied to the general public, under the Essential Principles of the Therapeutic Goods (Medical Devices) Regulations 2002 and its guidance Supplying electronic instructions for use (eIFU) for medical devices. The manufacturer must document a risk assessment, provide the instructions on a website or electronic media, and supply a paper copy on request without delay or cost. Devices supplied to the general public and IVD medical devices must include paper instructions; electronic instructions can be offered in addition. The TGA consulted in 2024 on allowing more flexible IFU formats and the government has approved the preparation of regulatory amendments, so the scope may widen; as of November 2026 the 2018 guidance still applies [11].

Brazil

ANVISA's RDC 751/2022, which replaced RDC 185/2001 and consolidated labelling and IFU rules, contains a dedicated section on instructions for use in non-printed format. The manufacturer or registration holder is responsible for making the electronic IFU available (a reference to ANVISA's own portal is not enough); the current version must be uploaded to ANVISA's medical device document repository (Article 33); and the outer label must indicate how to obtain the corresponding IFU, for example through a download address or a QR code (Article 51). As under the previous rules, devices for home use by lay persons and IVDs for self-testing remain on paper [12].

Saudi Arabia

The Saudi Food and Drug Authority's Requirements for Electronic Instructions for Use (eIFU) of Medical Devices (2020) permit eIFU for medical devices and IVDs intended for use by healthcare professionals. Devices for self-use and point-of-care IVDs are excluded. The manufacturer must complete and maintain a risk assessment, state on the labelling that the IFU is electronic, display release date, jurisdiction and version in the document, retain versions for at least 2 years after the expiry of the last device (15 years for devices without an expiry date), and host the files on a website without login, with adequate cybersecurity and minimal downtime [13].

Japan

Japan went further than any other market. Following the 2019 amendment of the Pharmaceuticals and Medical Devices Act, electronic package inserts became the default for prescription medicines, medical devices and IVDs from 1 August 2021 (with a two-year transition). Users scan the GS1 barcode on the outer box with the PI-navi app to open the current package insert; marketing authorisation holders must publish the insert on PMDA's website and register it in the Safety Information Posting System. Products bought directly by consumers keep paper inserts [14].

Taiwan

Under Article 33 of the Medical Devices Act, the Taiwan FDA has announced the device items for which an electronic manual may replace the Chinese-language paper manual. Permitted formats are built-in help systems, portable electronic media and the manufacturer's website; the label or package must explain how to obtain a paper manual and give the manufacturer's contact details. Check the current announcement for the item list before relying on it [15].

At a glance

What every eIFU implementation must therefore provide

Whatever the market, an eIFU platform has to cover the same seven obligations: a documented risk assessment; an always-available, secure website with no login; every version kept with its publication date for 10 to 15 years; a paper-copy process with a measurable response time; the eIFU indicator and access information on the label; a stable URL that can be registered in UDI databases; and a validation file that shows the system does what the regulations say. A home-built intranet page or a PDF on the corporate site rarely meets all seven, which is why most manufacturers now use a dedicated service.

eLeaflet™ by myHealthbox is built for exactly these obligations: a validated platform (EU GMP Annex 11, FDA 21 CFR Part 11) that publishes IFUs in 45 languages on the global eIFU search engine and, if you prefer, on your own company address, with version history, e-signature approval, QR and GS1 Digital Link access on the pack, and a built-in paper-copy request. If your IFUs are still in the box, request a demo and we will show you what going electronic involves for your product range.

References

1. Regulation (EU) 2017/745 (MDR), Annex I, section 23.1(f) — the primary permission for non-paper instructions for use. https://eur-lex.europa.eu/eli/reg/2017/745/oj
2. Commission Implementing Regulation (EU) 2021/2226 — conditions for eIFU (Articles 4–7). https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj
3. Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 — extends eIFU to all professional-use devices; in force 16 July 2025. https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj/eng
4. Commission Decision (EU) 2025/2371 — Eudamed modules mandatory from 28 May 2026; legacy device registration by 28 November 2026. https://eur-lex.europa.eu/eli/dec/2025/2371/oj
5. Regulation (EU) 2017/746 (IVDR), Annex I, section 20.1(f) — eIFU for professional-use IVDs, except near-patient testing. https://eur-lex.europa.eu/eli/reg/2017/746/oj
6. Swissmedic — Implementation of the EU Implementing Regulation on instructions for use in electronic form (8 August 2025). https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices/anwendbare-rechtsakte-gemaess-eu-mdr/umsetzung-eu-durchfuehrungsverordnung-gebrauchsanweisungen.html
7. MHRA — Guidance on the regulations for electronic instructions for use of medical devices (UK MDR 2002, regulation 4J). https://www.gov.uk/government/publications/electronic-instructions-for-use-of-medical-devices-guidance-on-regulations/guidance-on-the-regulations-for-electronic-instructions-for-use-of-medical-devices
8. FDA — Section 206 of MDUFMA: new section 502(f) of the FD&C Act (electronic labeling for prescription devices used in health care facilities). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/section-206-medical-device-user-fee-and-modernization-act-mdufma-new-section-502f-federal-food-drug
9. 21 CFR 801.109 — Prescription devices; 21 CFR Part 809 — In vitro diagnostic products. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-D/section-801.109
10. Health Canada — Guidance on the labelling of medical devices, including IVDs (Medical Devices Regulations SOR/98-282, s. 21(2) e-labelling). https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-labelling-medical-devices-including-vitro-diagnostic-devices-appendices.html
11. TGA — Supplying electronic instructions for use (eIFU) for medical devices. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices
12. ANVISA — RDC 751/2022 (instructions for use in non-printed format; Articles 33 and 51). https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000751&seqAto=000&valorAno=2022&orgao=RDC%2FDC%2FANVISA%2FMS
13. SFDA — Requirements for Electronic Instructions for Use (eIFU) of Medical Devices (2020). https://www.sfda.gov.sa/sites/default/files/2021-12/REQ1En_0.pdf
14. PMDA — Information regarding newly introduced electronic package inserts. https://www.pmda.go.jp/english/safety/info-services/e-pack-ins/0001.html
15. Taiwan FDA — Announcement under Article 33 of the Medical Devices Act on electronic manuals replacing Chinese manuals (via MOHW/TFDA). https://www.mohw.gov.tw/cp-115-72610-2.html
16. FDA — Summary of the Medical Devices Technical Corrections Act (MDTCA) (2004 extension of section 502(f) electronic labeling to prescription devices used by health care professionals and to professional-use IVDs). https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa-fees/summary-medical-devices-technical-corrections-act-mdtca

This article is a regulatory overview for information purposes, current as of 9 November 2026. It is not legal advice. Check the official texts, which are linked above, before taking a product decision.