Make sure your IFU says everything it must — before your auditor checks.
What Gordios checks in your instructions for use, and why it matters.
Book a demoThe IFU is a regulated document, not a leaflet.
The instructions for use are where regulatory information and information-based risk controls live. What they must contain is prescribed — and audited.
Prescribed content, not free text
EU MDR Annex I, Section 23 sets out exactly what the IFU must contain — manufacturer identification, intended purpose, warnings, contraindications, symbols, UDI. Missing elements are among the first things an auditor checks.
It carries your risk controls
When a risk is mitigated by information for safety, that mitigation only exists if the warning, precaution or contraindication actually appears in the IFU. The IFU is where those controls become real.
It must stay consistent
Intended purpose, warnings and identification must align across the IFU, the label, the risk analysis and your claims. A divergence between them is a finding waiting to happen.
It evolves with the device
Every device change can add a hazard or change a warning. An IFU that doesn't keep pace with the risk file leaves silent gaps — hard to spot, costly in audit.
What Gordios examines, point by point.
Every check is located in your documents. Every gap is explained — not a global score, but a traceable, actionable result.
| Domain checked | What Gordios verifies | Coverage |
|---|---|---|
| Mandatory information | Manufacturer identification, intended purpose, UDI and required regulatory information per EU MDR Annex I §23 | Audited |
| Warnings & precautions | Presence and clarity of warnings, precautions and contraindications | Audited |
| Risk-to-IFU traceability | Every risk mitigated by information for safety has a matching warning or precaution in the IFU | Audited |
| Intended purpose & users | Intended purpose, intended users and use environment stated and consistent with the technical file | Audited |
| Symbols & language | Harmonised symbols explained, and language and version requirements met | Audited |
| Cross-document consistency | Consistency between the IFU, the label, the risk analysis and the intended purpose | Audited |
From risk to warning — without a broken link.
Every risk you mitigate through information for safety must surface as a warning in the IFU. Gordios checks that the link holds.
IFU checkpoints verified
of audit-prep time saved
to your first report
They trust us
A true digital auditor that pinpointed the gaps in my technical file in just a few minutes.
Thomas BalverdeRegulatory Affairs ManagerWe saved time and money by bringing Gordios in from the very start of development.
Andrea BallarinCEO, Hippocrate CareHow Gordios checks your IFU.
Three steps, on your real documents. No configuration, no prior training needed.
You import your documents
Your instructions for use, risk analysis, label and intended-purpose statement — you upload what you have. Gordios adapts to your documentation structure.
Gordios checks the IFU
The tool verifies the IFU against regulatory requirements and cross-checks it against your risk analysis: presence, consistency, traceability. Automatically.
You receive a traceable report
Every result is located in your documents. Every gap is explained. You know what holds up and what needs attention — with the exact source to back it up.
The most frequent gaps Gordios detects.
Not poorly-written notices — but IFUs drafted without the auditor's perspective.
A residual-risk warning is missing
The risk analysis calls for the user to be warned. The IFU doesn't carry the warning — the risk control exists only on paper.
Contraindications absent or incomplete
The IFU lists what the device does, but not when it must not be used. Contraindications are missing or buried.
Intended purpose drifts
The intended purpose worded in the IFU no longer matches the label, the risk file or the clinical evaluation.
Mandatory information missing
A required element — UDI, manufacturer details, or a harmonised symbol — is absent or unexplained.
Warnings that aren't traceable
Generic warnings are present, but none can be traced back to a specific identified risk. The link to the risk analysis is missing.
The IFU wasn't updated
The device evolved; new hazards appeared. The IFU still reflects an earlier version — old warnings, new risks.
IFU check — common questions.
Want to learn more?
Schedule a meeting with one of our specialists to best address your needs!
Book a demo