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.
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The challenge
IVDR brings the same eIFU framework as MDR, with its own nuances
- UDI and LOT control matter moreIVD devices need UDI-linked, LOT-controlled access to the correct documentation.
- IVDR timelines are still unfoldingManufacturers need regulatory readiness that keeps pace with evolving deadlines.
- Notified body scrutiny is increasingIVDR technical file requirements demand a compliant, well-documented eIFU platform.
Our solution
A platform built for IVD-specific eIFU requirements
- IVD-specific hostingIFU hosting structured to IVDR compliant document requirements.
- UDI and LOT linkingCorrect IFU access linked to device UDI and controlled by LOT.
- EUDAMED readyIntegration support for IVD device registration.
How Matrix eIFU supports IVDR compliance
IVD-specific hosting, UDI linking, and EUDAMED readiness in one platform.
IVD-specific hosting
IFU 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 access
Multi-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 bodies
Full 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
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