Matrix eIFU for EUDAMED Readiness

Ensure eIFU content is structured, linked, and accessible in line with EUDAMED's UDI and device registration requirements, ahead of full activation.

The challenge
Our solution

How Matrix eIFU supports EUDAMED readiness

Structured, linked, and ready ahead of mandatory activation.

EUDAMED-aligned structureUDI linking and URL structure built to match EUDAMED's requirements.

  • UDI linking aligned with EUDAMED data requirements

  • eIFU URLs structured to meet mandatory EUDAMED requirements

  • Device and variant registration support across your portfolio

Ready for submissionDocumentation prepared to support EUDAMED technical file submissions.

  • Documentation to support EUDAMED technical file submissions

  • Ongoing platform updates as EUDAMED modules activate

  • Reduces last-minute compliance risk

Applies to every MDR/IVDR manufacturerRelevant to all manufacturers required to register in EUDAMED.

  • Applies to all EU MDR and IVDR manufacturers

  • Keeps eIFU content correctly linked to device records

  • Avoids disruption to EU market access

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