Technical Documentation Ready for Notified Body Review
Technical files structured to Annexes II and III of MDR 2017/745 — built to be reviewed, and to be maintained.
Scope
What’s Included
- Technical file structure per Annexes II and III
- Design dossier support for Class IIa and IIb devices
- Device description and specifications
- Risk management file integration
- Clinical evaluation integration
- Label and IFU (instructions for use) review
- Biocompatibility and performance data organisation
- Software documentation where applicable
Fit
Who It’s For
- Manufacturers compiling their first technical file
- Files needing restructuring after gap analysis findings
- Legacy documentation moving to MDR 2017/745 format
Deliverables
What You Receive
- A technical file ready for Notified Body review
- Supporting annexes and documentation
- A document control and versioning system
Limits
What’s Not Included
- Generating test data — laboratory testing, biocompatibility studies and clinical investigations run with your chosen partners
- Translations of labels and IFU
- Ongoing document maintenance after handover — available as a separate arrangement
Timing
Indicative Timelines
Typically 2–4 months, depending on device complexity and the test data already available.
Ready to Build Your Technical File?
Free initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026