Paper-on-Demand Fulfilment with Matrix eIFU
Meet the paper-on-demand requirement under Reg (EU) 2021/2226 Article 4, providing a free paper copy of the Instructions for Use to any user who requests one.
For taking a demo with our team.
The challenge
Paper-on-demand is a real regulatory obligation, not a footnote
- It's a condition of going electronicReg (EU) 2021/2226 Article 4 only permits electronic-only IFUs if a free paper copy is available on request.
- Auditors check this specificallyNotified bodies actively verify paper-on-demand fulfilment during eIFU System audits.
- International fulfilment is complexRequests can come from anywhere your devices are sold, each with its own logistics.
Our solution
A built-in request and fulfilment workflow, fully logged
- Integrated request mechanismUsers can request a paper copy directly on your branded eIFU website.
- Configurable fulfilment workflowsRequests route automatically to the right fulfilment process.
- Full audit trailEvery request and its fulfilment is logged for regulatory traceability.
Core capabilities
A fully logged workflow for one of the most-checked eIFU requirements.
Built-in request mechanism
Users can request a paper IFU directly from your branded eIFU website.
Integrated paper-on-demand request mechanism
Configurable fulfilment workflows
International request fulfilment, including printing and shipment
Full compliance traceability
Every request is logged to demonstrate compliance during an audit.
Request logging for regulatory traceability
Audit trail of every request and its fulfilment
Meets Reg (EU) 2021/2226 Article 4 requirements
Zero compliance gaps
Removes the operational risk of missing a paper-on-demand obligation.
No manual tracking of paper requests
Ready for notified body review
Audit-checked requirement, fully covered
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