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.
For taking a demo with our team.
The challenge
Meeting the conditions for electronic-only IFU delivery is strict
- Conditions must all be metThe device must not be for lay use, a free paper copy must be available on request, and the eIFU must be hosted on a stable public website.
- Labelling must reference the eIFUDevice labelling must clearly reference the eIFU URL or QR code.
- Notified bodies check this closelyFalling short on any single condition puts electronic IFU delivery, and your compliance status, at risk.
Our solution
A platform built specifically to satisfy every MDR eIFU condition
- Validated hostingA hosting environment that meets eIFU regulation requirements out of the box.
- Paper-on-demand handledPaper copy fulfilment with a full audit trail, ready for inspection.
- Full labelling supportBranded eIFU URL and QR code generation for device labelling.
How Matrix eIFU supports MDR compliance
Every condition for electronic-only IFU delivery, covered.
Regulation-ready hosting
A 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 fulfilment
Free 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 manufacturer
Applies 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
