Companion Diagnostics (CDx) (IVDR)
IVDR reference: Art. 2 definition; conformity assessment consultation with medicines authorities / EMA as applicable
BPG reference: CDx notes under Device Description; performance evaluation expectations for associated medicinal products
Checklist
- [ ] CDx identification: associated medicinal product INN, decision context, target population
- [ ] Medicinal product authorisation path (EMA centralised vs national CA) stated for NB consultation
- [ ] Annex II 1.1(c)(ix) elements complete in DD and IFU
- [ ] Clinical performance evidence supports patient selection/exclusion consistent with drug labelling/authorisation
- [ ] Risk management covers harm scenarios from incorrect biomarker classification
- [ ] Labelling/IFU clearly state joint interpretation with the specified medicinal product
- [ ] Change impact assessment when drug label or assay performance changes