ISO 24884:2026

• Abstract:

  This document provides requirements and recommendations on the conditions (means of delivery) and minimum required information to deliver when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). The content of the eIFU is not in the scope of this standard, as it is covered by the documents in the ISO 18113 series.

• Status: Published
• Publication Date: 06-Sep-2026
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Drafting Committee: ISO/TC 212/WG 3 - In vitro diagnostic products
• Current Stage: 6060 - International Standard published
• Start Date: 07-Sep-2026
• Due Date: 20-Feb-2027
• Completion Date: 07-Sep-2026

ISO 24884:2026 is an ISO standard for electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). It specifies the minimum information that must still be supplied and the conditions for delivering eIFU, so manufacturers, users and regulators can judge whether an electronic delivery approach is suitable.

What does ISO 24884:2026 specify?

ISO 24884:2026 sets requirements and recommendations for the means of delivery and the minimum required information for eIFU for IVDs. It does not cover the content of the instructions themselves; that content is handled by the ISO 18113 series.

The document is organized into six clauses:

• Clause 1 - Scope
• Clause 2 - Normative references
• Clause 3 - Terms and definitions
• Clause 4 - General requirements
• Clause 5 - Minimum required information to be physically supplied when the IFU is provided in an electronically accessible form
• Clause 6 - Conditions to allow a manufacturer to provide an IFU in an electronically accessible form

What are the key requirements of ISO 24884:2026?

ISO 24884:2026 links eIFU delivery to existing IVD labelling rules, risk management, accessibility, and secure online or device-based access. In practice, this means a manufacturer must not just post a file online - it must show that users can find, trust, and use the information safely.

Core points from Clauses 4 to 6

• Clause 4 requires the eIFU content to follow ISO 18113-1, ISO 18113-2, ISO 18113-3, ISO 18113-4 and ISO 18113-5, and the symbols to follow ISO 15223-1. This keeps the electronic format aligned with the normal manufacturer information rules.
• Clause 5.1 to 5.4 requires minimum information to remain physically supplied with the device when the IFU is electronic. That includes an eIFU indicator, information to identify the applicable version, and support for an alternative way to obtain the paper IFU if the eIFU is exclusive. This matters because the user still needs to know where the current instructions are and how to get them if access fails.
• Clause 5.2 says the eIFU indicator must be unambiguous and immediately recognizable. It may be a text string, a symbol, or a symbol with direct access information such as a URL or QR code. This helps users identify electronic instructions without guesswork.
• Clause 6.1 and 6.2 cover mixed paper/electronic supply and revision control. The electronic version must match the paper version when the paper copy is supplied, updates are allowed later, and safety or performance changes must be clearly communicated. If a revision is driven by safety concerns, users must be notified and told how to get the latest eIFU.
• Clause 6.3 requires documented risk assessment showing that electronic delivery maintains or improves safety. The assessment has to consider emergencies where paper is needed, usability, intended user capability, the needed hardware and software, verification and validation, and digital risks such as version mismatches and user interface complexity.
• Clause 6.4 and 6.5 address website accessibility and data security. If a website is used, accessibility must be validated, and any data collected to identify the user must be protected with appropriate confidentiality, integrity and availability measures.
• Clause 6.6 to 6.8 focus on practical access and continuity. Users should be able to reach the file without excessive navigation, access to a reader or download tool should be available, service interruptions should be reduced as far as possible, eIFU must stay available for the product lifecycle, and the file should be in a generic read-only format such as PDF.

What terms does ISO 24884:2026 define?

• electronic instructions for use (eIFU) - instructions for use supplied by the manufacturer in an electronically accessible form for an IVD.
• electronic instructions for use indicator - the indication, using an appropriate symbol or text, that the device is accompanied by electronic instructions for use.
• in vitro diagnostic medical device (IVD) - the device category covered by this standard.
• instructions for use (IFU) - the manufacturer-supplied instructions and information used to operate the device safely and correctly.
• risk assessment - the documented evaluation used to judge whether electronic delivery is safe enough compared with paper delivery.
• applicable revision of the IFU - the current version that the user should rely on for the device and its present status.

Who uses ISO 24884:2026?

ISO 24884:2026 is used by IVD manufacturers, regulatory and quality teams, label and document-control staff, website and software teams, and cybersecurity specialists. It is also relevant to buyers, laboratories, point-of-care users, and self-testing product teams that need to understand how eIFU will be delivered and maintained. Regulators and auditors can use it to check whether the chosen electronic delivery method, version control, and access controls are suitable.

Which standards are used with ISO 24884:2026?

Standard	What it contributes
ISO 15223-1:2021	Symbols used with information supplied by the manufacturer, including the symbol linked to the eIFU indicator
ISO 18113-1	Terms, definitions and general labelling requirements for IVDs
ISO 18113-2	Labelling content for IVD reagents for professional use
ISO 18113-3	Labelling content for IVD instruments for professional use
ISO 18113-4	Labelling content for IVD reagents for self-testing
ISO 18113-5	Labelling content for IVD instruments for self-testing
ISO 14971	Risk management process used for the safety assessment of electronic delivery
ISO 7000	Registered graphical symbols, including the symbol used with the eIFU indicator

What does the ISO 24884:2026 document contain?

ISO 24884:2026 contains the clause structure for scope, references, terms, general requirements, physical information to supply with an electronic IFU, and conditions for providing eIFU. It also includes practical requirements for indicators, version identification, alternative access, revision handling, website access, security, availability, and file format. The bibliography points to related guidance and regulatory references used in the field of IVD labelling and electronic information supply.

International
Standard
ISO 24884
First edition
Electronic instructions for use for in
2026-09
vitro diagnostic medical devices —
Minimum required information and
means of delivery
Instructions électroniques d'utilisation des dispositifs médicaux
de diagnostic in vitro — Informations minimales exigées et
moyens d'administration
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Minimum required information to be physically supplied when the IFU is provided in
an electronically accessible form . 2
5.1 General .2
5.2 Indication of electronic instructions for use .2
5.3 Information on how to identify the applicable version of the IFU .3
5.4 Support to provide alternate ways for IFU accessibility .3
6 Conditions to allow a manufacturer to provide an IFU in an electronically accessible
form . 3
6.1 Provision of IFU in both paper and electronic versions .3
6.2 Applicable revision of IFU .3
6.3 Risk assessment .3
6.4 Website accessibility .4
6.5 Data security .4
6.6 IFU accessibility . .4
6.7 IFU availability .5
6.8 File format .5
Bibliography . 6

iii
Foreword
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
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in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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This document was prepared by Technical Committee ISO/TC 212, Medical laboratories and in vitro diagnostic
systems.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
Manufacturers of in vitro diagnostic medical devices (IVD), supply users with information to enable the
safe use and the expected performance of their devices. The type and level of detail varies according to the
intended uses and country-specific regulations.
The International Medical Device Regulators Forum (IMDRF) encourages convergence of the evolution
of regulatory systems for medical devices at the global level. Eliminating differences among regulatory
jurisdictions can allow patients earlier access to new technologies and treatments. At the international
level, the use of electronic instructions for use (eIFU) for different types of IVDs continues to expand which
creates the need for a harmonized approach for eIFUs in the IVD sector.
IMDRF encourages manufacturers to employ the most appropriate methods of delivering information.
Modern technologies enable instructions for use (IFU) and technical information to be provided using a
more efficient means of delivery. Information can be digitally encoded on magnetic or appropriate storage
media relevant with the state-of-the-art technologies, displayed on a screen, incorporated in the device,
or even transmitted over the internet at the time of use. While these advances offer users the possibility
of more timely availability of critical information, such as performance changes, and offer manufacturers
more effective means of disseminating the information, a harmonised approach for a minimum required
information and conditions for eIFU delivery (i.e. website availability, data security) is lacking thus far. In a
fast-developing digital world a global standardization of eIFU requirements is crucial to promote their safe
and effective use across the globe. Therefore, this document will help manufacturers, users and regulators
to better align on and implement the minimum requirements and means of delivery for eIFUs.
This document provides a basis for harmonization of the requirements for electronic instructions for use for
IVD medical devices. More specifically, this document covers the minimum required information to deliver
and means of delivery for eIFUs for IVDs. Its focus is with the IFUs supplied with professional use, near-
patient testing or point of care, and self-testing IVDs. The document entails the information on management
of IFU revisions, risk assessment, website accessibility, data security, IFU accessibility and availability, and
file format.
This document is intended to support the essential eIFU requirements of all the IMDRF partners, as well as
other countries that have or plan to enact eIFU regulations for IVD medical devices. Users shall be aware of
applicable regulations.
This document is not intended to be used alone. It contains terms and definitions used in the ISO 18113 series
and in ISO 15223-1. Where synonyms are given, either term may be used but the first term is preferred.
Some definitions had to be modified for relevance to IVD labelling or to conform to ISO terminology rules. In
these cases, the source is given and indicates that the definition has been modified. In some cases, additional
notes or modifications to existing notes were needed to clarify the application to IVD medical devices, and
notes that did not apply to IVD medical devices were omitted.

v
International Standard ISO 24884:2026(en)
Electronic instructions for use for in vitro diagnostic medical
devices — Minimum required information and means of
delivery
1 Scope
This document provides requirements and recommendations on the conditions (means of delivery) and
minimum required information to deliver when providing electronic instructions for use (eIFU) for in vitro
diagnostic medical devices (IVDs).
The content of the eIFU is not in the scope of this standard, as it is covered by the documents in the ISO 18113
series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the
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