eIFU done right: compliant, accessible, and audit-ready.

REGULATORY AFFAIRS CONSULTING

Under the latest revision to Regulation (EU) 2021/2226 for electronic IFUs, any device for professional use can remove the paper IFU, relying only on an electronic IFU.

Compliance is not trivial though - risk assessment, website security, verification & validation are all easier with the right knowledge and experience.

  • As of June 2025 (and Implementing Regulation 2025/1234), electronic IFU can now be used for any medical device, that is intended for use by professional users.

    This applies to medical devices, their accessories (per MDR Article 2) and Annex XVI devices.

    IVDs are still a special case, lacking a clear legislative route for electronic IFU. There are still routes to compliance though - get in touch for advice.

  • There are a number of detailed requirements, but they broadly cover:

    • Verification and validation of the design of the website,

    • Cybersecurity and data protection,

    • Analysis of risks relating to the provision of the IFU electronically,

    • a conclusion (supported by evidence) that providing the IFU only electronically improves or maintains the level of safety of a paper IFU,

    • other procedural and labelling requirements.

  • Yes. It is a clear requirement of Regulation (EU) 2021/2226 Article 5(3) that the manufacturer must be able to provide a paper copy within 7 days when requested. This period may be shorter if your risk assessment identifies a need for it, and there must be no cost to the device user.

A young man with short dark hair, wearing glasses and a light blue dress shirt, smiling at the camera against a plain beige wall background.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

BIO

“Implementing electronic IFU is a no-brainer for most companies with professional use devices. Despite the implementation costs, the savings of print, shipping and version management are highly desirable. ”

- Joseph Langley

Ready to ditch printing?

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QUESTIONS & ANSWERS

  • You can, but it substantially increases the resource requirement for the project. You’ll need appropriate software expertise to verify & validate the system, particularly in relation to cybersecurity and uptime/display requirements.

    This is why many companies prefer to go with an “off the shelf” IFU hosting provider, who can provide the verification & validation data during procurement.

  • Based on our experience in notified body audits, manufacturers tend to have trouble with:

    • Making version history clear & available.

    • Making it clear when an IFU was revised for safety reasons.

    • Linking the eIFU risk assessment to the device’s risk management file.

  • The primary benefit is saving on printing costs - but this goes further. Often manufacturers outsource printing of IFUs, and thus if they make a change to it, have to scrap stock of the old IFU.

    Version management becomes easier - just make the new approved version live on the website. Users are instantly working with the latest version, rather than the version printed and placed in the box (which could have been years ago, considering long shelf lives).

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Page last updated: July 2026.