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Platform

Electronic Labeling (eIFU)

Electronic IFUs remove leaflets from the box, not the obligation behind them. The regulatory weight sits in version control and availability: showing the right document for the device in a customer's hand, including devices sold years ago.

What it does

Versioned with the printed label.

The eIFU and the label it corresponds to move together, so a customer following a link from a package reaches the version that applies to that device.

Previous versions retained

Versions still in the field remain published and identifiable, as the regulation requires, not archived out of sight.

Language sets per market.

The languages a market requires are published for that market, resolved from the same market configuration that drives destination labeling.

Open access

Content is reachable without registration or payment, which is a condition of relying on electronic supply rather than a courtesy.

How it works

  1. Author against the device record.

    eIFU content is bound to the product record, so it is clear which devices and versions a document applies to.

  2. Approve alongside the label.

    The document goes through electronic approval like any other controlled content, and is released with the label revision it belongs to.

  3. Publish with version identity.

    Each version is published so it can be identified and reached directly, including from a printed carrier on the package.

  4. Keep the field set available.

    Versions corresponding to devices still in use stay available, and paper-on-request obligations are tracked.

Regulatory context

What this speaks to.

The regulations and standards this capability is built against. Always check the current text of any regulation before relying on it.

  • EU Regulation 2021/2226: electronic instructions for use
  • EU MDR Annex I Chapter III: information supplied with the device
  • FDA guidance on electronic labeling for prescription devices
  • 21 CFR Part 11: version and approval records

Questions about this capability.

Can an eIFU fully replace the paper leaflet?

Only for the device categories and conditions set out in EU Regulation 2021/2226, and a paper copy must still be supplied on request within the stated period. It is a conditional permission, not a general substitution.

How long must previous eIFU versions stay published?

For as long as devices using them remain in use, which in practice means well beyond the current revision. That is the reason version identity has to be designed in rather than added later.

Related capabilities

Destination Labeling

Market-specific language, symbols and regulatory content applied automatically by ship-to destination, from one approved template.

Label Management

Design, approve and print labels from one controlled source, with electronic approval and a complete audit trail on every change.

Traceability

Full genealogy from incoming material to shipped unit, queryable for the product's regulatory retention period.

Ditch the manual redlining.

Watch automated audit trails build themselves.

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