Quick definition: An eIFU is a digital version of the Instructions for Use that gives users up-to-date device information online (and paper on request), while maintaining equivalent safety, accessibility, and compliance as paper IFUs.
What is eIFU? It’s the validated, controlled, online presentation of device instructions (including safety, indications, warnings, and maintenance) that users can access free of charge, with the most current approved version available and a paper copy provided on request within a reasonable timeframe.
(Always assess user risk, connectivity, and local regulatory allowances.)
Need help structuring content or selecting tools? Our team at Network Partners Group can align eIFU with your broader medical device labeling strategy and the capabilities of your pharma labeling system.
No. eIFU is not universally accepted. Regulations differ by country, device risk class, and user population. Many authorities allow eIFU only for professional-use devices, not home-use. Some require a transitional period, mandatory user access safeguards, or evidence of equal safety versus paper. Before switching, perform a market-by-market regulatory assessment, verify permissible scope, and document your rationale in the technical file. Where eIFU is restricted or infrastructure unreliable, keep a validated paper fallback and a process to supply it quickly. Finally, monitor updates from regulators and standards bodies so deployment remains fully compliant as rules evolve and guidance clarifies acceptable controls.
Yes. Users should be able to request a paper copy at no extra cost within a defined timeframe. Document this commitment in your IFU and website, and make the request path obvious—phone, email, web form, and postal address. Maintain controlled, printed masters so the paper version matches the current approved electronic revision, language, and region. Track requests, fulfillment timing, and shipping proof in your quality system. For critical devices or markets with limited internet access, keep local inventory to shorten lead times. Validate readability and durability of paper output, and test the end-to-end process under audit conditions.
Plan for outages. Provide offline PDFs on the device, media, or facility network; use local caching within your app; and affix QR codes that also resolve to downloadable files hosted redundantly. Distribute critical quick-start or safety pages in both electronic and laminated mini-paper formats. Publish a 24/7 support contact with a live escalation path and service-level targets. Use a status page and fallback domains/CDNs to improve resilience, and monitor uptime with alerts. Include clear risk analysis explaining mitigations in your technical documentation and training. Finally, simulate downtime drills so clinicians know exactly how to retrieve instructions reliably offline.
Use device-specific URLs or QR codes that encode model and UDI, directing users to the correct language and revision. Display a prominent revision code, effective date, and hash on every page and PDF. Log page views and downloads with timestamps, user role, device identifier, IP region, and referrer. Store immutable audit records in your quality system, linked to the released DMR/DHF and change orders. For embedded apps, capture which version was shown and confirm acknowledgement. During complaints or field actions, query analytics to determine the exact revision accessed, then document findings in investigation and regulatory reports and training.
Maintain consistency with governance. Establish a master terminology list, style guides, and glossary per language. Use translation memory and term bases in your Translation Management System (TMS) so recurrent phrases remain identical across releases. Route updates through in-country reviewers or notified-body accepted linguists, documenting qualifications. Bundle changes by release cycle to minimize fragmentation and rework, and freeze strings before validation. Automate source extraction from structured content (DITA or component CMS) to prevent manual copy errors. Track translation status, approvals, and version mapping in your quality system. Finally, run back-translation checks and usability testing to confirm content is accurate and clear.
Christine Bonifield is the Senior Director of the Labeling Center of Excellence at Network Partners Group, where she leads a team of over 40 labeling consultants. With a rich background in life sciences labeling, Christine has extensive expertise in guiding clients towards optimized labeling strategies and managing comprehensive labeling projects. She is a proven leader in the industry, passionate about promoting and encouraging labeling professionals across various sectors. Christine holds a Master of Arts from Ball State University and a Bachelor of Science from Indiana University.
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