Unlocking European Markets: Companion Diagnostics (CDx) Strategy Under IVDR

Medical Device Global Market Access · Feb 9, 2026 · 3m

This episode details the significant regulatory complexities for Companion Diagnostics (CDx) under the European Union's In Vitro Diagnostic Regulation (IVDR). We explore why these devices are now in a higher risk class, the impact of mandatory consultations with medicinal authorities like the EMA, and the critical need for seamless coordination between IVD manufacturers and their pharmaceutical partners to ensure timely market access. Key Questions: - What makes Companion Diagnostics (CDx) a unique challenge under the EU IVDR? - Why are most CDx considered high-risk Class C devices? - How…