Blog · 16 June 2026

eIFU transition checklist: 10 steps from paper to compliant electronic instructions

Switching from paper to electronic instructions for use is a well-trodden path — the regulation defines the guardrails and the pitfalls are known. This 10-step checklist takes you from the first eligibility check to a running, compliant eIFU process.

1. 1. Confirm eligibility

   Verify that the devices are intended for professional users. Since 16 July 2025 (Regulation (EU) 2025/1234) eIFU is an option for every such device regardless of class; for lay users paper remains mandatory.

2. 2. Run the risk assessment

   Document the assessment required by Regulation (EU) 2021/2226: user profile, internet access in the use environment, consequences of unavailability, fallback scenarios. Make it audit-ready — notified bodies will ask for it.

3. 3. Choose the platform

   Decide between building and validating your own infrastructure or using a proven eIFU platform. Required either way: guaranteed availability, security, version management, access via REF/UDI code and multilingual support.

4. 4. Prepare the documents

   Convert instructions to a widely used electronic format (typically PDF), consolidate language versions and establish naming and version conventions per SKU.

5. 5. Update labels and packaging

   State clearly on the label or packaging how to access the eIFU: website URL and the REF or UDI code the user enters. Update label artwork and technical documentation accordingly.

6. 6. Set up paper-on-request

   Define the process for providing a free paper copy within the prescribed time, including logging of requests — it is a compliance requirement, not a courtesy.

7. 7. Handle registration duties

   Reference the eIFU URL where required: EUDAMED once available, national routes meanwhile (e.g. the RZPRO registry in Czechia). Check each market's authority practice.

8. 8. Integrate with your QMS

   Update technical documentation, IFU-related SOPs and change management so every eIFU update follows a controlled, traceable process.

9. 9. Pilot on one product line

   Publish eIFU for a limited portfolio first, verify access flows, availability monitoring and the paper-request process in practice, then roll out.

10. 10. Maintain and monitor

    Keep versions archived for the required period, monitor portal availability, and update the instructions within hours whenever safety information changes — that is the core benefit of eIFU.

Steps 3, 9 and 10 are where a platform earns its keep: DocuLiv provides the secured portal, REF/UDI access, version archive and paper-request handling out of the box, so your team focuses on the regulatory steps that only you can do.