Insights & Knowledge

Expert articles, guides, and whitepapers on eIFU compliance, regulatory requirements, and digital transformation in medical devices.

Updated January 2025

EU eIFU Regulatory Status

eIFU Allowed

Professional-use medical devices and IVDs(subject to applicable regulatory requirements)

Paper Required

• Home-use devices
• IVD self-tests & near-patient tests

Key Conditions

• Downloadable & printable
• Free paper on request
• Validated availability

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Jan 20, 20256 min read

eIFU Compliance Starts with Validation

Learn why system validation is the foundation of eIFU compliance and how to ensure your electronic Instructions for Use platform meets regulatory requirements under EU MDR and IVDR.

Feb 2, 20265 min read

Summary of Commission Implementing Regulation (EU) 2025/1234

Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help.

Oct 15, 20258 min read

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

MedTech Europe has taken another significant step in its push for digital healthcare, publishing new guidance on eIFU for near-patient tests following its position paper on lay-use devices.

EU eIFU Regulation Readiness Checklist

Interactive self-assessment tool to evaluate your organization's readiness for EU eIFU regulations. Check your compliance status across key regulatory requirements.

May 29, 20245 min read

The Future of Post-Market Surveillance in IVD and MD Industry: Leveraging eIFU

Post-market surveillance has become more critical than ever. Learn how eIFU can revolutionize PMS in the IVD and MD industry.

Apr 5, 202410 min read

Practical Steps to a Successful eIFU Implementation

This document contains a high-level process overview of all the steps necessary to successfully move towards electronic Instructions For Use (eIFU).

Mar 20, 202412 min read

Software Requirements for a Compliant eIFU Website Development

This document contains an overview of software requirements for an eIFU website and how the Software Development Life Cycle (SDLC) can serve as a guide to create a compliant system.

Feb 28, 20244 min read

New IVDR/MDR Overview of Language Requirements for Manufacturers of Medical Devices

The European Commission published an overview of language requirements for medical device manufacturers. Learn what this means for eIFU.

Feb 23, 20245 min read

eIFU Versus Paper-Based IFU: What Are the Benefits of Going Digital?

Why do more and more manufacturers choose to move to eIFU? Learn about the range of benefits of replacing paper-based manuals with electronic instructions.

Implementation

Sustainability

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