Find every EU MDR gap before your notified body does.
What Gordios checks in your technical documentation, and why it matters.
Book a demoEU MDR in practice: a file that has to prove itself.
The MDR doesn't just ask for documents. It asks for a technical file where every claim of conformity is backed by traceable evidence, kept current across the device lifecycle.
The GSPR are the backbone
Annex I sets out the general safety and performance requirements. Each applicable requirement must be addressed, the solution stated, and the evidence referenced. A GSPR checklist with empty evidence columns is the first thing an assessor opens.
Evidence, not assertions
Claiming a requirement is met is not enough. The technical documentation must point to the test, the report or the standard that proves it. Without that link, conformity exists on paper only.
Clinical evaluation and PMS
The clinical evaluation report and the post-market surveillance plan are living parts of the file. Reduced to one-off deliverables, they become the gaps a reviewer relies on finding.
One file, kept consistent
Risk management, clinical evaluation, labelling and the IFU must all tell the same story. A device that evolves without the whole file keeping pace creates silent inconsistencies — costly under review.
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 |
|---|---|---|
| Technical documentation | Completeness and structure of the technical documentation per EU MDR Annex II and III | Audited |
| GSPR (Annex I) | Each applicable general safety and performance requirement addressed, with the solution and evidence referenced | Audited |
| Clinical evaluation | Presence and consistency of the clinical evaluation report with the device and its intended purpose (Annex XIV) | Audited |
| Risk management | Risk management file present and traceable to the GSPR and the rest of the technical documentation | Audited |
| Labelling & IFU | Mandatory label and instructions-for-use information per Annex I §23, consistent with the file | Audited |
| Post-market surveillance | Post-market surveillance plan and procedures present and consistent with the device class (Annex III) | Audited |
From requirement to evidence — without a broken link.
Every general safety and performance requirement must be linked to the evidence that proves it. Gordios checks that the chain is unbroken.
EU MDR analysis points
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 ManagerGordios was a game-changer in setting up our quality system.
Dr Céline BesnierCEO, SportSantéClicHow Gordios audits your technical file.
Three steps, on your real documents. No configuration, no prior training needed.
You import your documents
Technical documentation, GSPR checklist, risk management file, clinical evaluation, labelling and PMS plan — you upload what you have. Gordios adapts to your documentation structure.
Gordios audits against the MDR
The tool verifies every point against EU MDR 2017/745: presence, consistency, traceability of evidence. Automatically, with no manual intervention.
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-made files — but files built without the assessor's perspective.
GSPR claimed without evidence
The checklist says a requirement is met. The column pointing to the proof is empty, or points to a document that doesn't address it.
The clinical evaluation is out of date
The CER reflects an earlier version of the device or hasn't been refreshed against recent literature. The reviewer notices; the manufacturer rarely does.
Technical documentation gaps
A required element of Annex II — device description, manufacturing information, verification data — is missing or incomplete.
Risk management not linked to the GSPR
The risk file exists, but its outputs aren't traced to the safety requirements they're meant to satisfy. The link is missing.
PMS plan absent or generic
The post-market surveillance plan is missing, or so generic it doesn't reflect the device, its class or its real-world risks.
The file tells two stories
Intended purpose, labelling, risk file and clinical evaluation disagree on a detail. Each was right once; the device moved on without all of them.
EU MDR audit — common questions.
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