Matrix eIFU for EU MDR Compliance

A validated, audit-ready eIFU solution purpose-built for the requirements of EU Regulation 2017/745 (MDR) and the associated eIFU regulations, EU 2021/2226 and EU 2025/1234.

The challenge
Our solution

How Matrix eIFU supports MDR compliance

Every condition for electronic-only IFU delivery, covered.

Regulation-ready hostingA validated hosting environment that meets eIFU regulation requirements from day one.

  • Validated hosting environment meeting eIFU regulation requirements

  • Branded eIFU URL and QR code generation for device labelling

  • Multi-lingual publication across all EU official languages

Paper-on-demand fulfilmentFree paper copy fulfilment with a full audit trail, ready for inspection.

  • Paper on demand fulfilment execution with audit trail

  • Version control and audit trail for notified body inspections

  • EUDAMED compatible UDI linking

Built for every manufacturerApplies to any manufacturer transitioning from paper to electronic IFU under MDR.

  • Applies to all EU market medical device manufacturers

  • Supports the full transition from paper to electronic IFU

  • Regulatory confidence from day one

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