EU IVDR Technical Documentation (Team-NB BPG-IVDR V2)
This section follows Team-NB Position Paper — Best Practice Guidance for the Submission of Technical Documentation under Annexes II and III of IVDR (EU) 2017/746 (BPG-IVDR V2, 2025-09-03).
Section map
| Topic | Page |
|---|---|
| Device description & specifications | device-description |
| Information supplied by manufacturer | information-supplied |
| Design & manufacturing | design-manufacturing |
| GSPR checklist | gspr |
| Benefit-risk & risk management | risk-management |
| Product verification & validation | verification-validation |
| Performance evaluation (PEP/PER) | performance-evaluation |
| PMPF | pmpf |
| SSP | ssp |
| PMS | pms |
| Companion diagnostics | companion-diagnostics |
| TD cover / submission | cover-letter |
Reguverse notes
- IVDR projects require an approved Device Description (DD) before PE / GSPR.
- Use IVDR clause numbering only.
- Evidence neighbour is performance evaluation (PEP/PER) and PMPF, not an MDR CER.