EU MDR · Regulation (EU) 2017/745 · Annex II / III · Annex XIV
A Notified Body review takes 13–18 months. Your technical file must be ready first.
Submission-ready CERs and Annex II/III technical documentation for SME and legacy-transition medical device manufacturers approaching the 2027–2028 MDR deadlines.
The entry point: a fixed-scope audit of your technical file
Technical File Gap Audit
Clause-by-clause review of your existing documentation against Annex II/III, and your clinical evaluation against Annex XIV and MEDDEV 2.7/1 Rev 4. You receive a written gap report and a prioritised remediation plan — before committing to any larger engagement.
- Written gap report, mapped clause-by-clause
- Prioritised remediation plan with effort estimates
- 60-minute debrief call
| Parameter | Value |
|---|---|
| Turnaround | 10 business days |
| Price | € [X,XXX] / $ [X,XXX] |
| Device classes | IIa · IIb · III · implantable |
| Output | Gap report (PDF) + remediation plan + call |
[PLACEHOLDER — final price to be set by founder]
Flagship engagements
| Engagement | Scope | Turnaround | Basis |
|---|---|---|---|
| FlagshipCER Writing & Remediation → | CEP, state-of-the-art review, evidence appraisal, benefit-risk conclusions, cross-document consistency. | 6–10 weeks | Scoped after audit |
| FlagshipTechnical File Compilation → | Annex II/III documentation compiled, structured and written to submission-ready state with full traceability. | 8–16 weeks | Scoped after audit |
| Post-Market Documentation Cycle → | PMS, PMCF, PSUR and SSCP updates as a structured annual cycle. | Per cycle | Scoped |
Who is doing the writing
[PLACEHOLDER — founder name, credentials, background: to be supplied. Nothing on this site is fabricated.]
Règle Santé is a specialist writing practice, not a body shop. Every document is written by the founder — working directly with your RA/QA and clinical teams from triage to delivery.
Scope, plainly: Règle Santé is not a Notified Body and does not issue, grant or guarantee CE marking. We prepare documentation. The manufacturer retains legal responsibility for conformity.
Free resource · One email, no spam
The MDR Technical File Checklist
Every required element of Annex II and Annex III as a working checklist — the same structure we use in paid gap audits.
PDF · Mapped to Annex II & III clause numbers