How to publish electronic Instructions for Use (eIFU) safely and compliantly

Electronic Instructions for Use (eIFU) are increasingly accepted by regulators and customers, particularly for medical device and in vitro diagnostics (IVD) manufacturers. Under EU MDR 2021/2226, eIFUs can be used in place of printed leaflets for certain device types, offering manufacturers a scalable, cost-effective way to deliver up-to-date, compliant documentation. But meeting regulatory expectations takes more than simply uploading a PDF.

What is an eIFU?

An eIFU is the electronic equivalent of the paper Instructions for Use. It is typically a controlled public PDF (or approved HTML) that reflects the current, approved instructions.

Manufacturers commonly make eIFUs available via a stable URL, which is often accessed by a QR code printed on packaging or device labels. Regulatory bodies in key markets - including the EU, UK, and U.S - permit the use of electronic IFUs in place of printed versions under specific conditions.

Who uses eIFUs and why?

eIFU-style publishing is increasingly common in regulated and high-tech sectors, particularly among medical device and IVD manufacturers. By delivering up-to-date, multi-language instructions via QR codes on packaging, they reduce paperwork and streamline access to critical documentation for global users.

The challenge with eIFUs

Publishing a PDF on a public website is easy. The difficulty lies in doing it in a way that maintains control over versions, approvals, translations, and compliance with regulatory expectations.

Many teams fall short of compliance by treating eIFU publishing as a simple upload task. Common pitfalls include hosting a “live” IFU online without a controlled lifecycle or formal approvals, and replacing PDFs without maintaining a proper audit trail of changes.

Key compliance considerations for eIFUs

Across major regulatory markets, the expectations for eIFU publishing are broadly aligned: manufacturers must be able to demonstrate that electronic instructions are reliably available, version‑controlled, and properly approved.

• In the EU, MDR 2021/2226 defines when eIFUs may replace paper IFUs and sets clear conditions around availability, version control, and a documented paper‑on‑request process.
• In the UK, current UK MDR 2002 remains closely aligned with EU requirements, and the MHRA expects the same level of control, traceability, and documented fallback to paper instructions.
• In the United States, the FDA permits electronic labelling in specific contexts under 21 CFR Part 801 and related guidance, with a strong emphasis on ensuring users can easily access the current, approved version and request paper copies when needed. When electronic records or signatures are used in approval workflows, 21 CFR Part 11 requirements also apply.

In practice, this means retaining approvals, publication history, and change records in your QMS (Quality Management System).

If you choose to track access to the eIFU (e.g. via logins or unique QR codes), UK and EU manufacturers must ensure personal data is handled in compliance with GDPR and the UK Data Protection Act, while U.S. manufacturers should focus on maintaining system validation, access control, and audit trail integrity under FDA expectations.

Best practices for publishing eIFUs

A compliant eIFU doesn’t just happen - it requires the right controls and attention to detail. Here’s what good looks like:

1. Keep the IFU a controlled document

Always author, approve and record the IFU inside your QMS. Publishing should be a controlled action with approvals logged.

2. Use stable public URLs

Each approved IFU should be published at a stable, publicly accessible URL. The URL should be static and not rely on temporary redirects.

3. Label packaging with QR codes

Packaging must display a QR code that links either directly to the IFU or to a language selection page. QR codes must be printed at high quality, with sufficient contrast and a minimum size of 10 mm to ensure reliable scanning. Near the QR code, include a clear statement with contact details or instructions for requesting a printed copy as a fallback. And, be sure to test your QR codes on real packaging mockups to ensure they scan reliably and direct users to the correct content.

4. Be explicit about tracking and privacy

Public eIFU URLs are anonymous by default, meaning they don’t record user identities. If you need to determine who accessed the IFU (for example, a hospital requiring proof), use portal logins or unique QR codes per customer/batch, along with a portal login.

5. Manage language variants

Publish each language as a separate, approved variant. Offer a language selector on the landing page or encode language in the URL. Ensure each language follows the same approval and version controls.

6. Keep a ‘paper on request’ process

Regulators often require manufacturers to offer paper copies on request. Make the process visible on the eIFU landing page (a short form or contact address), and log the fulfilment as part of your QMS.

7. Maintain an archive and change log

Keep prior versions accessible (archived) with clear timestamps and approval metadata. This supports audits and complaint investigations.

8. Plan for outages and availability

Host published PDFs from a reliable portal (not your internal web server) and publish an uptime/availability statement for customers. For high-risk devices, consider redundancy and an SLA (Service Level Agreement).

How Cognidox enables compliant eIFU publishing

In addition to following eIFU best practices, you also need the right tools. To ensure your electronic instructions are consistently approved, traceable, and accessible, your publishing workflow must be fully integrated with your document control process.

That’s where Cognidox comes in.

Cognidox helps life science organisations publish eIFUs and other regulated documents - such as datasheets, ISO certificates and Certificates of Analysis (CoAs) - as controlled, public PDFs. These documents are QR-ready and hosted on a secure platform: the Cognidox Extranet Portal.

This approach ensures your content stays fully controlled within your QMS, while making the latest approved version easily accessible to end users. It also supports compliance with eIFU requirements in the EU, UK and U.S.

A step-by-step guide to publishing eIFUs with Cognidox

Step 1: Author and approve your IFU

Use the Lean eQMS to control approvals and retain version history.

Step 2: Publish via Public Licence

Assign a public licence to generate a stable, extranet-hosted URL - perfect for QR codes.

Step 3: Choose your access model

Opt for public access (for open viewing via QR code), or enable tracking (via portal logins or Limited Access Groups).

Step 4: Publish language variants

Upload approved translations as separate documents, with optional language selector.

Step 5: Finalise packaging and SOPs

Test your QR codes, then update your packaging and labelling SOPs to reflect the new process.

Step 6: Let Cognidox manage the archive

All superseded versions are retained automatically, with full audit history and timestamps.

Conclusion

Electronic IFUs (eIFUs) offer a smarter, more scalable way to deliver up-to-date product information - reducing printing costs, improving accessibility, and supporting global compliance. But publishing them safely isn’t as simple as uploading a PDF. To meet regulatory expectations, your eIFUs must be controlled, traceable, and reliably delivered.

Cognidox gives you the tools to do exactly that. With built-in version control, public publishing via the Extranet Portal, and full support for language variants and audit trails, you can modernise your eIFU process without compromising compliance.

Ready to simplify and secure your eIFU publishing? Book a demo to see how Cognidox can help you deliver compliant, QR-ready electronic Instructions for Use with full control and traceability.

FAQs

1. Are eIFUs accepted by all regulators?

A: Not universally. In the EU, eIFUs are allowed under MDR 2021/2226 for specific device classes. The UK remains aligned with EU requirements for now, although the MHRA is reviewing potential regulatory divergence in upcoming device legislation. In the U.S., the FDA permits eIFUs for certain devices when manufacturers meet the criteria outlined in 21 CFR Part 801 and relevant guidance. Always consult the latest local regulations for your target market.

2. Do we still need to provide printed IFUs?

In most cases, yes - or you must offer a clear, documented process for users to request a printed copy. That process should be visible and auditable, typically via the eIFU landing page or packaging insert.

3. What does “compliant” eIFU publishing actually involve?

Compliance means the eIFU must be version-controlled, approved, and made reliably available. You also need to keep full audit trails (approvals, changes, publication history) and ensure users always access the correct version - ideally via a stable URL or QR code.