What Companion Diagnostics (CDx) - IVDR & Global Regulatory Requirements (2026) requires
Regulatory framework governing Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746. It addresses the co-development of drugs and CDx, requiring Notified Body assessment of the CDx and mandatory consultation with a medicinal products competent authority (e.g., EMA).
Pillar: Medical & Healthcare · Authority: European Medicines Agency (EMA) & Medical Device Coordination Group (MDCG) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746
SHA-256 integrity: d5ee43931a18563f3d331ef31791edf369ea468ae05bdf2884e712bb4bfc66d9
Primary Citations — 2 traced to source
- Regulation (EU) 2017/746 (IVDR) Article 48
- EMA Guideline on the predictive biomarker-based assay development in the context of drug development and lifecycle
Access
- Discovery (free): /api/v1/nodes/companion-diagnostics-ivdr-2026.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/companion-diagnostics-ivdr-2026.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/companion-diagnostics-ivdr-2026
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