MedTech Europe has taken another significant step in its push for digital healthcare. Following its 2025 position paper calling for eIFU acceptance for selected lay-use medical devices, the organisation has now published a new booklet — "Greener, Smarter Healthcare: Electronic Instructions for Near-Patient Tests."
Key Resources:
This new publication highlights the same message: paper IFUs are outdated, environmentally burdensome, and misaligned with modern healthcare. Whether for home-use medical devices or near-patient diagnostics, the direction is clear. Europe is moving toward broader acceptance of electronic Instructions for Use (eIFU).
Together, both documents reflect a strong and consistent industry-wide momentum toward digital access to medical device information.
The Regulatory Landscape: MD and IVD Regulations Are Evolving
Medical Devices
In July 2025, Regulation 2025/1234 expanded the scope of Regulation (EU) 2021/2226, allowing eIFU for all medical devices intended for professional users. This major change goes far beyond the previous narrow categories (implants, fixed installations, certain software).
Now eligible for eIFU when used by professionals:
- Cardiovascular devices
- Orthopaedic devices
- Endoscopy equipment
- Dental devices
- Wound management products
- And many more
In Vitro Diagnostics (IVDs)
For IVDs, the rules remain more restrictive:
- Professional-use IVDs may already use eIFU
- Near-patient tests (NPTs) and self-tests still require paper under current law
However, MedTech Europe's new booklet explicitly advocates for eIFU acceptance for Near-Patient Tests, citing overwhelming professional user preference and clear sustainability benefits.
The Industry Trend Is Clear
Across both MD and IVD sectors, the momentum is unmistakable:
- Broader regulatory acceptance
- Stronger political support
- Clear professional preference
- Consistent industry messaging
- Growing emphasis on sustainability and digital access
eIFU is moving from a niche option to a mainstream solution.
Why Paper IFUs Are Becoming Outdated
Paper IFUs face increasing limitations, especially in decentralised and real-world settings:
- Availability issues — Often not available where the device or test is used
- Environmental impact — Costly due to printing, packaging, and distribution
- Update delays — Slow to update, increasing the risk of outdated or inconsistent information
- Accessibility challenges — Harder to read and navigate, especially for users with visual or cognitive challenges
- Modern workflow mismatch — Not suited for 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.
The Case for eIFU
MedTech Europe's advocacy is driven by compelling evidence:
Healthcare Professional Preference
Nearly 90% of healthcare professionals prefer electronic IFU over paper alternatives.
Key Benefits
- Instant updates — Reducing the burden and risks of outdated content
- Better readability — Scalable text, visuals, audio, and video support
- Environmental alignment — Supports the EU Green Deal and environmental targets
- Modern care fit — Perfect for decentralised care and mobile environments
- Reduced waste — Less packaging, lower logistics effort and cost
- Inclusivity — Supports multilingual access
Patient Acceptance
The European Patients' Forum survey found that 58% of patients are open to receiving device instructions exclusively in digital form, demonstrating increasing acceptance even among lay users.
MedTech Europe's Position on 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
Example devices:
- Contact lenses
- Urinary catheters
- Diabetes care and monitoring devices
The paper emphasised three core pillars:
- 1Accessibility — Improved clarity and dynamic content
- 2Sustainability — Reduced waste, aligned with Packaging and Waste Regulation 2025/40
- 3Simplification — Faster updates and reduced administrative burden
The industry clearly sees digital access as safer, greener, and more user-friendly.
"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.
EEline Heylen
eIFU expert at IFUcare
How IFUcare Supports This Transition
With regulatory and industry momentum accelerating, manufacturers need a partner who can deliver validated, compliant, and audit-ready eIFU solutions.
IFUcare provides:
- 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.