Free resource · Regulation (EU) 2017/745
The EU MDR Technical File Checklist
Every required element of Annex II and Annex III, structured the way a Notified Body reviewer reads it — written to be self-auditable. Tick only what you could defend in review; the empty boxes are your gap list.
What it covers
1Device description & specification
2Information supplied by the manufacturer
3Design & manufacturing information
4General Safety & Performance Requirements
5Benefit-risk analysis & risk management
6Verification & validation, incl. clinical
7Post-market surveillance documentation
Why it helps
From checklist to remediation plan
The single most common Notified Body finding is not a missing document — it is the same fact stated differently across the CER, IFU, risk file and label. This checklist is built to surface exactly those inconsistencies, not just absent sections.
Once you have your empty boxes, the next step is triage: which gaps are blocking, which are major, which are minor, and in what order to close them. That written triage — with effort estimates — is exactly what a Technical File Gap Audit delivers.
See the Gap Audit