Digital Instructions for Use (eIFU) now Evolving for Lay Users

The landscape of medical device information is undergoing a digital transformation.

Traditionally, Instructions for Use (IFU) were exclusively provided in paper form, especially for devices intended for lay users. However, the global shift toward digital information — and the expanding acceptance of electronic Instructions for Use (eIFU) in professional settings — has sparked a discussion on how these advancements can safely benefit lay users as well.

Electronic IFUs offer dynamic, accessible, and up-to-date user guidance across devices. New regulatory developments now propose extending eIFU use beyond professional health settings, to support certain medical devices used by lay persons — provided safe conditions around training and recurrent use are met.

In this post, we explore why eIFU for lay users is important, how accessibility and impact are considered, what types of devices are being discussed, how other regions have approached this concept, and the core features that modern eIFU solutions should include.

Accessibility

At the heart of the eIFU conversation is accessibility. The digital delivery of instructions recognises that health-related information must be easy to find, understand, and interact with — regardless of format and today’s connected users increasingly expect online access to information. For example, recent data suggests that a large majority of households have reliable internet access and that mobile devices are central to how people access content.

Well-designed eIFUs improve accessibility in ways that paper instructions cannot:

• Improved readability: Users can adjust text size, contrast, and language settings.
• Alternative media: Audio and video elements support users with visual or cognitive impairments.
• Real-time updates: Digital content can reflect the most current safety and usage guidance, reducing risks associated with out-of-date paper leaflets.
• Multilingual support: eIFU platforms can serve instructions in multiple languages without increasing product packaging.

Unlike paper IFUs — which may be mislaid, hard to read, or not updated — a well-designed electronic IFU ensures that users always have access to the latest and most accessible version of the instructions.

Further Impacts

The benefits of expanding eIFU to include lay users extend beyond accessibility.

Going digital can produce system-wide sustainability gains:

• Environmental impact: Eliminating bulky paper leaflets reduces waste and carbon emissions associated with printing and transport.
• Package reduction: Smaller packaging can translate into logistical efficiencies and reduced material costs.
• Administrative simplification: Digital content can be updated and managed in a central repository, cutting down on revision cycles for manufacturers, distributors, and regulators.
• Enhanced user engagement: Digital instructions can incorporate interactive elements that support learning and correct use — particularly relevant for devices that require ongoing self-care.

• These implications demonstrate how digital instructions align with broader digital health priorities — such as sustainability, efficiency, and patient empowerment — while maintaining safety and clarity.

Medical Devices for Lay Users Accompanied by eIFU Where Initial Information Is Provided by a Professional

To ground the discussion in real-world context, the following device categories have been identified as frequently used by lay persons after initial professional instruction and recurrent use.

These examples show where eIFUs might be considered when users are already familiar with the device through training:

• Contact lenses and related care products.
• Urinary catheters and accessories (e.g., bags, hangers).
• Diabetes home-management devices, including glucose monitors, insulin pumps, sensors, infusion sets, and pen needles.
• Home-care medical equipment such as CPAP machines, oxygen concentrators, and suction units.
• Mobility aids like wheelchairs, crutches, and orthoses.
• Home-use respiratory and nebuliser systems.

In each case, the lay user often first receives hands-on training from a healthcare professional and subsequently performs recurrent or routine activities. This creates a context where supportive digital guidance could enhance safety and proper use — without replacing essential clinical instruction.

Developments & Acceptance of eIFU for Lay Users Worldwide

Interest in digital IFU formats is not limited to one region. Around the world, regulatory bodies and health authorities are exploring how to modernise instruction delivery while safeguarding user outcomes:

• Australia: The national regulator has been consulting on more flexible IFU formats, including digital access for broader categories of users For more information.
• Belgium: Legislative agreements include language on partial digital labelling, indicating movement toward eIFU consideration.
• Canada: Health authorities are actively modernizing medical device information requirements, with digital IFU practices being evaluated in alignment with international best practices For more information.
• India: Certain regulatory frameworks already permit eIFU as the primary form of IFU for many devices without restriction, showing a progressive stance on digital information For more information.
• Vietnam, Thailand, South Korea: eIFU for lay users also allowed based on: For more information
• Malaysia, Peru and other countries are also introducing important changes in this area.

These developments highlight a global trend: regulators recognise the value of digital instructions but seek proportional safeguards, particularly where lay users are involved.

Conclusions: What Modern eIFU Solutions Should Deliver

If eIFU is to serve lay users effectively, platforms must offer more than a simple PDF on a website. A comprehensive digital IFU solution should include:

• Secure, user-friendly access (intuitive navigation on web and mobile).
• Multilingual support with localisation capabilities.
• Adjustable formats (text resizing, audio, video, contrast controls).
• Real-time updates with version control and change notifications.
• Offline support where possible, or easy re-access when connectivity is limited.
• Clear indication on packaging that eIFU is available digitally.
• Robust backup and continuity strategies to ensure availability during outages.
• Compliance with data protection and accessibility standards (e.g., GDPR and accessibility guidelines).
• Option to request a paper copy upon demand.

By delivering these features, electronic Instructions for Use become not just a digital replica of paper leaflets, but a richer, more supportive information environment that aligns with how modern users learn, interact, and manage their health.

If you’re thinking about transitioning to eIFU — whether for professional or selected lay-user devices — the path forward is digital, accessible, and user-centred.