MedTech Europe Pushes for Wider Adoption of eIFU: What It Means for Manufacturers

A new position paper by MedTech Europe, the European Federation of Precision Mechanical and Optical Industries (eurom) and the European Association of the contact lens and lens care industry (EUROMCONTACT), calls on EU regulators to expand electronic Instructions for Use (eIFU) to cover certain medical devices intended for patient or home use (so-called lay-use devices), a move that could accelerate the digitalization and sustainability of healthcare across Europe.

A New Step in Digital Healthcare

Following the recent update of EU Regulation 2021/2226 by Regulation 2025/1234, eIFU has already been extended to all professional-use devices. Now, MedTech Europe proposes taking this a step further to include devices used by non-professionals, where users receive initial professional guidance and engage in recurrent use of the product.

Examples include contact lenses, urinary catheters, and diabetes management devices: tools that patients handle frequently and confidently after training by healthcare professionals.

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Key Benefits of eIFU Expansion

According to the position paper, expanding eIFU access to lay users supports several EU priorities:

Accessibility: eIFU offers more user-friendly and inclusive access to up-to-date information, including dynamic content like audio or video, especially beneficial for people with visual or cognitive impairments.
Sustainability: Eliminating paper IFUs reduces packaging, waste, and emissions, aligning with the European Green Deal and the Packaging and Waste Regulation 2025/40.
Simplification: Digital documentation minimizes administrative burden and ensures faster updates and better information accuracy.

A recent European Patients’ Forum survey found that 58% of patients are open to receiving device instructions exclusively in digital form, further underscoring the readiness of the market for this transition.

Regulatory Alignment and Future Outlook

MedTech Europe urges the Medical Devices Coordination Group (MDCG) to set up a dedicated workstream within its New Technologies Working Group to develop a practical roadmap for implementation by 2026.

This step would bring Europe closer to a fully digital and environmentally sustainable approach to medical device information—while maintaining the risk assessment safeguards already defined under Article 4 of EU Regulation 2021/2226.

Why It Matters for You

The expansion of eIFU to lay-use devices reflect the growing industry recognition that digital access is not only possible but preferred. Manufacturers are encouraged to begin a preliminary assessment of how this potential scope expansion may affect their product portfolios and current eIFU strategies. By preparing early, companies can benefit from the advantages of eIFU more rapidly should regulators move forward with adopting this proposal into formal legislation.

As a full-service eIFU provider, IFUcare welcomes this initiative. Developed by regulatory experts, IFUcare’s platform helps medical device and IVD manufacturers digitize technical documentation in a compliant, validated, and sustainable way.

“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,” says Eline Heylen, eIFU expert at IFUcare.

Read the full position paper:

Electronic Instructions for Use (eIFU) for Certain Medical Devices Intended for Lay Users – MedTech Europe, eurom & EUROMCONTACT (Sept 2025)