The EU MDR Technical File Gap Audit
Before you commit to remediation, know exactly what is missing. A clause-by-clause audit of your technical documentation against Annex II/III and your clinical evaluation against Annex XIV — delivered as a written report your team and your Notified Body reviewer can both follow.
What we review
| Documentation area | Reviewed against | Depth |
|---|---|---|
| Device description & specification | Annex II, s.1 — incl. UDI, variants, accessories | Clause-by-clause |
| Design & manufacturing information | Annex II, s.3 | Structural |
| GSPR checklist | Annex I / Annex II s.4 — evidence mapping | Clause-by-clause |
| Benefit-risk & risk management | Annex I Ch. I, ISO 14971 alignment | Structural |
| Clinical evaluation (CER/CEP) | Annex XIV Part A, MEDDEV 2.7/1 Rev 4, MDCG guidance | Clause-by-clause |
| PMS / PMCF documentation | Annex III, Annex XIV Part B, MDCG 2020-7/8 | Structural |
What you receive
- Written gap report (typically 15–25 pages), mapped to Annex II/III and Annex XIV clause numbers
- Severity rating for every gap — blocking, major, minor — from a reviewer's perspective
- Prioritised remediation plan with effort estimates and suggested sequence
- 60-minute debrief call with written summary
The report is written to be handed on: your internal team can execute the plan themselves, give it to another consultancy, or engage us for the remediation. The audit has no lock-in by design — that is the point of it.
[PLACEHOLDER — redacted sample report page, to be supplied by founder]
Ten business days, four steps
Access & triage
Secure document transfer, scope confirmation, device context call (30 min).
Clause-by-clause review
Documentation reviewed against Annex II/III, Annex XIV and applicable MDCG guidance.
Report writing
Findings written up with severity ratings and a sequenced remediation plan.
Delivery & debrief
Report delivered; 60-minute walkthrough call with your RA/QA team.
Questions buyers ask
Is this a certification or approval?
No. Règle Santé is not a Notified Body and does not issue, grant or guarantee CE marking. The audit is an independent documentation review; the manufacturer retains legal responsibility for conformity.
What do you need from us?
Read access to the current technical documentation set and one 30-minute context call. No site visit required — we work remotely across EU, US and Asian time zones.
What if our file is mostly fine?
Then the report says so, with the short list of what remains. A clean audit before NB submission is worth as much as a long gap list — it tells you that you're ready.
How do we pay?
Fixed fee, invoiced in EUR or USD, 50% on booking and 50% on delivery.
Know where your file stands in ten days.
Send your device class and current documentation status — we confirm scope and start date within one business day.