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.

The challenge
Our solution

Core capabilities

A fully logged workflow for one of the most-checked eIFU requirements.

Built-in request mechanismUsers 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 traceabilityEvery 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 gapsRemoves 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

Hear from our customers

Moving from paper to electronic IFU with Matrix eIFU was perfectly guided and supported. No more printing, shipping, or inventory of paper IFUs — and a significant financial benefit for our organisation.

Regulatory Affairs Manager, Leading orthopedic devices manufacturer in Switzerland

Matrix One is trusted by 500+ Life Sciences & Medical Device Companies