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.
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The challenge
EUDAMED's phased activation leaves little room to delay preparation
- Registration ties directly to UDIEUDAMED requires devices to be registered with UDI information linked to documentation, including eIFU.
- Public accessibility is requiredDevice records, and their linked eIFU, need to be accessible to the public and competent authorities.
- Late preparation means last-minute riskManufacturers who delay eIFU readiness risk compliance gaps as modules activate.
Our solution
eIFU infrastructure ready ahead of EUDAMED deadlines
- UDI linking aligned to EUDAMEDDevice and eIFU linking structured to match EUDAMED's data requirements.
- EUDAMED-ready URLseIFU URLs structured to meet mandatory EUDAMED requirements.
- Ongoing platform updatesThe platform updates as EUDAMED modules are activated.
How Matrix eIFU supports EUDAMED readiness
Structured, linked, and ready ahead of mandatory activation.
EUDAMED-aligned structure
UDI 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 submission
Documentation 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 manufacturer
Relevant 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
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