Updated: MedTech Europe Pushes for Wider Adoption of eIFU – Now Across Both Lay-Use Devices and Near-Patient Tests

Why Paper IFUs Are Becoming Outdated

Paper IFUs face increasing limitations, especially in decentralised and real-world settings:

• Often not available where the device or test is used
• Environmentally costly due to printing, packaging, and distribution
• Slow to update, increasing the risk of outdated or inconsistent information
• Harder to read and navigate, especially for users with visual or cognitive challenges
• Not suited for modern remote, mobile, or point-of-care workflows

The new NPT booklet directly highlights these issues, especially in settings like ambulances, urgent care, and GP practices where fast access to the right information matters.

Why eIFU Makes Sense

MedTech Europe’s advocacy is driven by strong evidence:

• Nearly 90 percent of healthcare professionals prefer electronic IFU
• Updates are instant, reducing the burden and risks of outdated content
• Digital formats support better readability with scalable text, visuals, audio, and video
• Aligns with the EU Green Deal and environmental targets
• Perfect fit for decentralised care and mobile environments
• Reduces packaging waste, logistics effort, and cost
• Supports multilingual access and inclusivity

The European Patients’ Forum survey also found that 58 percent of patients are open to receiving device instructions exclusively in digital form, demonstrating increasing acceptance even among lay users.

What MedTech Europe Said About Lay-Use Devices

In its earlier joint position paper with eurom and EUROMCONTACT, MedTech Europe urged regulators to permit eIFU for specific lay-use devices, especially when:

• The device is used repeatedly
• The user receives initial professional training
• Digital access would improve safety or usability

Examples include:

• Contact lenses
• Urinary catheters
• Diabetes care and monitoring devices

The paper emphasised:

• Accessibility: improved clarity and dynamic content
• Sustainability: reduced waste, aligned with Packaging and Waste Regulation 2025/40
• Simplification: faster updates and reduced administrative burden

The industry clearly sees digital access as safer, greener, and more user-friendly.

As Eline Heylen, eIFU expert at IFUcare, summarised:

“The direction set by MedTech Europe confirms the shift toward digital compliance and accessibility. It’s encouraging to see sustainability and usability move hand in hand.”

IFUcare’s Role in This Transition

With regulatory and industry momentum accelerating, manufacturers need a partner who can deliver validated, compliant, and audit-ready eIFU solutions.

IFUcare supports manufacturers with:

• A pre-validated eIFU website matching your branding
• Full IEC 62304 software lifecycle compliance
• ISO 13485 and ISO 27001 certified quality and security
• 24/7 global call center for paper requests
• Version tracking, update notifications, and audit logging
• Access control for professional users, distributors, or patients
• Multilingual support in over 55 languages

This gives manufacturers a smooth, compliant, and future-proof transition to eIFU.

Conclusion

MedTech Europe’s publications — both the lay-use position paper and the new Near-Patient Test booklet — confirm a consistent trend:

Europe is moving toward broader acceptance of digital IFU across medical devices and diagnostics.

While some categories still require paper today, the momentum is clear. Manufacturers who prepare early will be ready for the next steps in regulation, sustainability requirements, and user expectations.

IFUcare continues to support this transition by offering a fully validated, compliant, and user-friendly eIFU solution trusted by manufacturers and Notified Bodies worldwide.