ISO 24884:2026 Explained: What the New eIFU Standard Means for IVD Manufacturers
On 7 September 2026, ISO published ISO 24884:2026, the first international standard dedicated to electronic instructions for use (eIFU) for in vitro diagnostic (IVD) medical devices. It sets the minimum information that must stay physical and the conditions a manufacturer must meet before it delivers IFUs electronically.
For regulatory affairs and quality teams, ISO 24884 gives one reference point across markets. For management, it answers a practical question: what does it take to move IVD instructions from paper to digital, and who carries which part of the work? Demand from users is clear: in a European Commission survey from August to October 2024, healthcare professionals showed a clear preference for electronic over paper IFUs (Regulation (EU) 2025/1234, recital 2).
This article explains the standard clause by clause, shows where the manufacturer is responsible and where an eIFU platform can help, and describes how Matrix eIFU supports ISO 24884 compliance.
In short:
ISO 24884 covers how eIFUs are delivered, not what the IFU says. Content stays with the ISO 18113 series.
The label or a physical leaflet must still show that an eIFU exists, where relevant, how to find the right version, and, for eIFU-only devices, how to get a free paper copy.
Electronic delivery requires a documented risk assessment, a validated website, data security, minimal downtime and a generic read-only file format such as PDF.
What is ISO 24884?
ISO 24884:2026 ("Electronic instructions for use for in vitro diagnostic medical devices: Minimum required information and means of delivery") is a six-page first edition, prepared by ISO/TC 212, Medical laboratories and in vitro diagnostic systems. The project was approved in February 2024 and the standard was published in September 2026 (ISO). It applies to IFUs for professional-use, near-patient (point-of-care) and self-testing IVDs.
The standard is intended to support the eIFU requirements of all IMDRF partners and of other countries that have or plan eIFU regulations. It lists the IMDRF labelling principles among its references (IMDRF/GRRP WG/N52). It does not replace national law. Manufacturers must still check local requirements, which can differ for professional and self-testing devices.
ISO 24884 works together with other standards:
ISO 18113-1 to -5 for the content of the IFU.
ISO 15223-1:2021 and ISO 7000 for symbols.
ISO 14971 for risk management.
ISO/IEC 27001 as a reference for information security.
Clause 5: what must still be physically supplied
Even with an eIFU, some information must travel with every device. It can go on the label, on a separate sheet or on other material in the package. The manufacturer should choose the means in a documented way, based on the applicable regulations and an ISO 14971 risk assessment that considers the intended user.
Three items are mandatory:
An eIFU indication. Either the ISO 7000-1641 / ISO 15223-1 "consult instructions for use or consult electronic instructions for use" symbol together with the eIFU indicator, or a prominent text string such as "eIFU" with a direct access means, for example a URL or QR code. The indicator must be unambiguous.
Version identification. Where relevant, the user must be able to identify which IFU version applies to the device in hand.
Alternative access. If the IFU is supplied only electronically, the user must be able to get the applicable paper IFU free of charge. The website address must be given where applicable.
For IVD instruments with a display, the standard also recommends a locally stored basic set of safety and operating instructions that works without a network connection.
Clause 6: conditions for providing an eIFU
Clause 6 lists the conditions a manufacturer must meet before it can deliver IFUs electronically.
| Clause | Topic | What ISO 24884 expects (paraphrased) |
|---|---|---|
| 6.1 | Paper and electronic versions | When both exist, the eIFU matches the paper IFU at the time of supply. Later updates are allowed. Video and audio may supplement the IFU. |
| 6.2 | Revisions | Updates are communicated clearly. Critical information from safety, performance or protocol changes is actively brought to users' attention. For safety-related revisions, a process exists to notify existing users. |
| 6.3 | Risk assessment | A documented assessment shows that eIFU keeps or improves safety. It covers emergencies, user skills, hardware and software, and digital risks such as software or AI model version mismatch. V&V evidence is required. |
| 6.4 | Website accessibility | A website that delivers eIFUs is validated. Passwords or other access controls are optional. |
| 6.5 | Data security | Data protection rules are respected. Confidentiality, integrity and availability risks are documented, including physical security, server certification and cybersecurity processes. |
| 6.6 | IFU accessibility | No excessive navigation. A reader for the file format is available. Downtime is minimized, and the impact of an outage is assessed. |
| 6.7 | IFU availability | The eIFU and its address are maintained over the product lifecycle. Older IFUs are available on request for the national retention period. |
| 6.8 | File format | Generic, read-only, printable format such as PDF. Files are protected for integrity and legibility. |
A notable element is that the risk assessment must explicitly cover digital-delivery risks, such as software or AI model version mismatches and user interface complexity.
Who is responsible: manufacturer or eIFU provider?
ISO 24884 compliance is always the manufacturer's responsibility. An eIFU platform cannot write the label or own the risk file. But a validated platform can cover most technical conditions and supply evidence for the rest.
| Area | Manufacturer | eIFU platform |
|---|---|---|
| IFU content (ISO 18113) and symbols (ISO 15223-1) | Owns it | Hosts the approved file |
| Label: eIFU indicator and version information (5.2, 5.3) | Designs the label | Provides a stable eIFU address and version history |
| Free paper IFU on request (5.4) | Ships the paper copy | Request form, tracking and reminders |
| Risk assessment (5.1, 6.3) | Owns it | Supplies V&V, usability and availability data as input |
| Revision notices (6.2) | Decides what is critical; runs FSCA | Displays notices and notifies subscribers |
| Website, security, availability, format (6.4 to 6.8) | Selects and qualifies the supplier | Delivers and validates the service |
For management, this split is the main planning input. The platform reduces technical work. The regulatory decisions stay in-house.
How Matrix eIFU supports ISO 24884 compliance
Matrix eIFU (formerly dokspot, founded in Zurich in 2014 and part of Matrix One since December 2025) has mapped its platform against every clause of ISO 24884:2026. The platform covers the platform-related conditions of clause 6 and gives manufacturers the evidence they need for clauses 5 and 6.3.
Label support and version control (5.2, 5.3, 6.2)
A manufacturer-owned eIFU website address for the label, plus an example label on the site that shows users how to identify their device.
Each document shows a "Valid from" date and a full version history. LOT-based documents link each IFU version to the device LOT.
The current version opens by default. A notice appears when a user opens an older version.
Product-line notifications can display before the eIFU opens, and users can subscribe to product updates.
Free paper IFU on request (5.4)
Every eIFU page has a paper-IFU request form. Requests are logged and followed up with daily reminders, and shipping can be tracked. Usability testing met the 95% success criterion for this task.
Validated website and direct access (6.3, 6.4, 6.6)
Software verification and validation with 1,400+ automated test cases.
Browser compatibility verified on 17 desktop and 12 mobile configurations.
Global availability confirmed from 58 locations, with optional country restrictions.
Users enter a REF, product name or LOT and go directly to the right documents. No login is needed, and an optional "healthcare professionals only" screen is available.
The platform software version is shown on every eIFU website, so the platform version in use is always traceable.
Data security (6.5)
Hosting on infrastructure certified to ISO/IEC 27001, ISO/IEC 27017 and ISO/IEC 27018.
HTTPS on all eIFU domains, secured with TLS encryption.
Role-based access with optional two-factor authentication, four-eye release and a full audit trail.
File integrity validated at upload with checksums.
Continuous database protection: immutable snapshots, typically at least every 24 hours and more often for frequently changing data, plus every committed transaction logged to highly available storage. This allows point-in-time rollback and full recovery after a hardware failure or data corruption.
GDPR-compliant processing with minimal personal data. Completed paper requests are anonymized after 30 days.
Independent penetration testing by an external security firm.
Availability and lifecycle (6.6, 6.7)
24/7 monitoring of the platform and every customer endpoint, with a down alert within 2 minutes.
A 99.5% annual uptime commitment, with public availability data since 2015 that manufacturers can use in their own risk assessment.
Previous IFU versions stay available through "View History" for the retention period the manufacturer sets.
File format and integrity (6.8)
Only PDF files can be published. They are viewable and downloadable on desktop and mobile and released only after approval.
Matrix eIFU is operated by dokspot GmbH, which holds ISO 9001:2015 certification.
Next steps for RA/QA teams and management
Run a gap assessment of your current eIFU process against clauses 5 and 6.
Update your risk file. Add digital-delivery risks: version mismatch, interface complexity, outages and cybersecurity.
Review your labels. Check the eIFU indicator, the access means (URL or QR code) and the version information.
Confirm your paper-on-request process, including response times and records.
Qualify your eIFU supplier. Ask for V&V reports, availability records, security evidence and a clause-by-clause compliance checklist.
Check local rules in each market. ISO 24884 does not replace national eIFU regulations.
Get ready for ISO 24884 with Matrix eIFU
Matrix eIFU has completed a clause-by-clause ISO 24884:2026 compliance checklist with references to its validation and quality evidence. Use it to qualify your eIFU supplier and to support your own risk assessment.
Book a Matrix eIFU demo to walk through the checklist with our team.
Sources
ISO 24884:2026: Electronic instructions for use for in vitro diagnostic medical devices, ISO
ISO/TC 212: Medical laboratories and in vitro diagnostic systems, ISO
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), EUR-Lex
Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use, EUR-Lex
Commission Implementing Regulation (EU) 2025/1234 amending Regulation (EU) 2021/2226, EUR-Lex
IMDRF/GRRP WG/N52: Principles of Labelling for Medical Devices and IVD Medical Devices, IMDRF
Matrix One acquires dokspot GmbH to launch Matrix eIFU, Matrix One
Matrix eIFU service status, public availability data since 2015
ISO 24884: frequently asked questions
ISO 24884 is a voluntary standard. It becomes relevant when regulators or notified bodies refer to it, and it is a strong reference for showing that your eIFU process is state of the art.
No. Regulation (EU) 2021/2226, as amended by Regulation (EU) 2025/1234, applies to medical devices under the MDR. Since that amendment, it covers all MDR devices for professional users. In the EU, IVDs fall under the IVDR (EU) 2017/746 instead. Its Annex I, Section 20.1(f) allows non-paper IFUs only for IVDs intended for professional use, and not for near-patient testing. ISO 24884 is an international standard specific to IVDs. It supports, but does not replace, the regulations of each market. Read our overview of 2021/2226 and 2025/1234.
No. IFU content stays with the ISO 18113 series. ISO 24884 covers the minimum physical information and the means of electronic delivery.
A QR code or URL can be the direct access means. If you do not use the ISO 7000-1641 symbol, it must come with a prominent text string such as "eIFU".
Yes, if the IFU is supplied only electronically. The applicable paper version must be available free of charge.