IFU and eIFU insights & knowledge

Expert articles, guides and whitepapers on IFU for medical devices, eIFU compliance and regulatory requirements.

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
Highest assured uptime

Read the summary of eIFU regulation (EU) 2025/1234

Featured

Webinar

Oct 7, 202645 min webinar

eIFU in practice: from regulatory requirements to implementation

Live webinar on 7 October 2026: what compliant electronic Instructions for Use actually require, and how to close the gap between the regulation and a working, audit-ready process.

Jul 22, 20266 min read

Your eIFU Link and EUDAMED: What the 28 November 2026 Deadline Means for Your Device Registrations

With EUDAMED registration deadlines approaching, manufacturers must ensure their eIFU links are stable, accurate, and aligned with UDI device registration requirements.

Jul 17, 20266 min read

Human Factors and Usability: The Part of eIFU Compliance Teams Still Underestimate

Discover why usability engineering and human factors are now essential to eIFU compliance, and how IEC 62366-1 supports safer digital instructions for use.

Jul 17, 20267 min read

Beyond the QR Code: Where Digital Labeling Is Actually Heading

Discover how eIFU is evolving beyond QR codes through UDI, EUDAMED, GS1 Digital Link, NFC, and connected digital labeling ecosystems.

Jul 17, 20266 min read

Why Early-Stage MedTech Companies Should Decide on eIFU Before Their First Submission

Discover why early-stage MedTech companies should make eIFU part of their regulatory strategy before their first submission to avoid costly redesigns and delays.

Jul 17, 20266 min read

IFU packaging best practices: the environmental case for eIFU

Discover how eIFU helps MedTech and IVD manufacturers reduce packaging waste, support PPWR compliance, and strengthen sustainability credentials.

Jul 17, 20266 min read

Where eIFU Is Heading for IVDs: What Manufacturers Should Watch Next

Discover the current eIFU rules for IVDs, the near-patient testing exception, and the regulatory developments manufacturers should monitor next.

Jul 7, 202612 min read

Build or Buy: A Technical Decision Framework for International eIFU Systems

Building an internal eIFU system costs three to five times more than buying over five years. Get the technical and regulatory evidence to make the right call.

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.

Compliance

EU MDR

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IFU and eIFU insights & knowledge

EU eIFU regulatory status

eIFU in practice: from regulatory requirements to implementation

Your eIFU Link and EUDAMED: What the 28 November 2026 Deadline Means for Your Device Registrations

Human Factors and Usability: The Part of eIFU Compliance Teams Still Underestimate

Beyond the QR Code: Where Digital Labeling Is Actually Heading

Why Early-Stage MedTech Companies Should Decide on eIFU Before Their First Submission

IFU packaging best practices: the environmental case for eIFU

Where eIFU Is Heading for IVDs: What Manufacturers Should Watch Next

Build or Buy: A Technical Decision Framework for International eIFU Systems

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

EU eIFU Regulation Readiness Checklist

Full regulatory references