Matrix eIFU for IVDR — In Vitro Diagnostics

Support for manufacturers of in vitro diagnostic medical devices in meeting EU Regulation 2017/746 (IVDR) eIFU requirements, as IVDR timelines continue to roll out.

The challenge
Our solution

How Matrix eIFU supports IVDR compliance

IVD-specific hosting, UDI linking, and EUDAMED readiness in one platform.

IVD-specific hostingIFU hosting structured to meet IVDR compliant document requirements.

  • IVD specific IFU hosting with IVDR compliant document structure

  • UDI linking for in vitro diagnostic devices

  • Global LOT controlled documentation access

Built for market accessMulti-lingual publication and EUDAMED support for EU market access.

  • Multi-lingual IFU publication for EU market access

  • EUDAMED integration support for IVD device registration

  • Validated hosting aligned with IVDR technical file requirements

Audit-ready for notified bodiesFull traceability, ready for notified body review at any time.

  • Audit trail and version history for notified body review

  • Applies to laboratory instruments, point-of-care tests, reagents

  • Applies to companion diagnostics manufacturers

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