EU IVDR Overview
EU IVDR (EU) 2017/746 governs in vitro diagnostic medical devices (IVDs) in the Union across the full lifecycle.
This knowledge base organises Technical Documentation (TD) around Team-NB Position Paper BPG-IVDR V2 (2025-09-03), aligned with IVDR Annex II and Annex III, plus performance evaluation deliverables (Article 56 / Annex XIII).
Quick links
- TD overview (BPG IVDR V2)
- Device description & specification — recommended mandatory first deliverable
- Performance evaluation (PEP / PER / PMPF / SSP)
- GSPR checklist
Relationship to EU MDR
| Topic | MDR | IVDR |
|---|---|---|
| Regulation | (EU) 2017/745 | (EU) 2017/746 |
| Core evaluation | Clinical evaluation (CEP/CER) | Performance evaluation → PER |
| Post-market follow-up | PMCF | PMPF |
| Safety & performance summary | SSCP | SSP |
References
- IVDR (EU) 2017/746, Annex II & III
- Team-NB Position Paper BPG-IVDR V2 (2025-09-03)