Technical File Compilation to Submission-Ready State
We compile, structure and write your Annex II/III technical documentation so a Notified Body reviewer can follow it without opening a deficiency round. Built for SME and legacy-transition manufacturers working against the 2027–2028 deadlines.
When you need this
Legacy MDD file transitioning to MDR
Your device is certified under MDD and the technical file was never restructured for MDR. The 2027/2028 deadline means the file must be rebuilt to Annex II/III before your Notified Body window closes.
First MDR submission
You are bringing a device to the EU market and need the technical documentation set built from the ground up — structured the way reviewers expect to read it.
File scattered across systems and authors
The evidence exists, but it lives in old reports, test summaries and department folders. It needs to be consolidated into one coherent, traceable documentation set.
NB pre-submission readiness
Your Notified Body has given you a submission slot. The file needs a structured completion pass so the review starts clean instead of opening with deficiency rounds.
What the compilation covers
| Documentation area | Reference | What we write / structure |
|---|---|---|
| Device description & specification | Annex II, s.1 | Intended purpose, variants, accessories, UDI, classification rationale |
| Information supplied by the manufacturer | Annex II, s.2 | Label and IFU consistency check against claims and clinical evidence |
| Design & manufacturing information | Annex II, s.3 | Design stages, manufacturing processes, suppliers and sites |
| GSPR demonstration | Annex II, s.4 | Requirement-by-requirement mapping of evidence, standards and justifications |
| Benefit-risk analysis & risk management | Annex II, s.5 | ISO 14971 file alignment with clinical evaluation and claims |
| Verification & validation documentation | Annex II, s.6 | Structured summaries of pre-clinical and clinical evidence, incl. CER |
| PMS documentation | Annex III | PMS plan, PMCF plan, and the post-market feedback loop into the CER |
Clinical evaluation is the deepest section of any technical file. Where the CER itself needs writing or remediation, it is scoped as a CER engagement inside or alongside the compilation.
What you receive
- Complete Annex II/III documentation set, structured for NB review
- Master document index with clause-level traceability
- GSPR matrix with evidence mapping and justifications
- Cross-document consistency check — intended purpose, claims, risk, clinical
- Gap log documenting every decision and open item for your RA lead
Scope, plainly: we prepare and structure documentation. Règle Santé is not a Notified Body; submission decisions and legal responsibility for conformity remain with the manufacturer.
The audit tells us both what this will take.
Every compilation is quoted from Gap Audit findings — so the scope is based on evidence, not estimates.