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

Overview

ISO 24884:2026 sets out the requirements and recommendations for delivering electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs). As medical devices adopt digital documentation, this international standard helps manufacturers, users, and regulators align on the minimum required information and acceptable means of delivering eIFUs. The standard supports the safe, effective, and harmonized use of IVDs across professional settings, near-patient testing, and self-testing environments. The actual content of the IFUs is outside the scope of this standard and is addressed by the ISO 18113 series.

Key Topics

ISO 24884:2026 addresses the following essential aspects:

• Minimum information to accompany electronic IFUs: Specifies what must be provided on device labeling, packaging, or included documents to direct users to electronic instructions.
• Indication of eIFU availability: Establishes requirements for clear, unambiguous eIFU indicators, such as symbols (e.g., ISO 15223-1), URLs, or QR codes.
• Version identification: Details how users can identify the applicable and current version of the eIFU, supporting transparency in product updates and safety communications.
• Alternate accessibility: Requires manufacturers, when supplying eIFUs exclusively, to offer users a means to obtain a paper version upon request, ensuring inclusivity and accessibility.
• Conditions for providing eIFUs: Outlines necessary manufacturer actions, including:
  • Assessment and documentation of risk when replacing paper with electronic delivery (aligned with ISO 14971).
  • Ensuring website or platform accessibility and cybersecurity (referencing standards like ISO/IEC 27001).
  • Maintaining eIFU availability and version control throughout the product lifecycle.
  • Providing eIFUs in widely compatible, read-only formats (e.g., PDF).

These requirements ensure coherent, accessible, and secure delivery of instructions, supporting patient safety and regulatory compliance.

Applications

ISO 24884:2026 is highly relevant for:

• IVD Manufacturers: Assists in streamlining regulatory submissions and compliance with international requirements when offering digital documentation.
• Regulatory Authorities: Offers a harmonized foundation for evaluating IVD manufacturer documentation processes, whether for professional or self-testing devices.
• Healthcare Providers and Laboratories: Facilitates timely access to up-to-date device instructions, helping manage risk and improve safe use in clinical and point-of-care settings.
• End Users (e.g., patients using self-tests): Guarantees that clear directions for accessing IVD instructions are always available, improving user safety and device effectiveness.

The standard applies to all stakeholders involved in the production, distribution, and regulation of IVDs adopting electronic documentation strategies.

Related Standards

ISO 24884:2026 references and aligns with several key international standards to ensure harmonized quality and safety, including:

• ISO 18113 Series: Covers the detailed content and labelling requirements for IVD medical devices, including reagents and instruments for professional and self-testing.
• ISO 15223-1:2021: Defines symbols to be used with medical device information supplied by manufacturers.
• ISO 14971: Focuses on risk management application for medical devices.
• ISO/IEC 27001: Addresses information security in electronic data management.
• ISO 20417: Sets requirements for information to be supplied by the manufacturer for medical devices.

Regulatory references such as the EU’s IVDR and GDPR underscore the standard’s consideration of regional and global compliance.

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By following ISO 24884:2026, organizations can better assure the accessibility, clarity, and reliability of electronic instructions for use in the IVD sector, promoting both safety and regulatory alignment as digital solutions in healthcare expand.

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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
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
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
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)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO’s adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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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