Cracking the Code: IVD Reimbursement in Europe vs. The United States

Medical Device Global Market Access · Sep 15, 2025 · 3m

This episode breaks down the critical differences in securing reimbursement for In-Vitro Diagnostics (IVDs) between the European Union's national HTA bodies and the payer-driven system in the United States. We explore the specific requirements of key European agencies like Germany's G-BA and France's HAS and contrast them with the evidence demanded by CMS and private insurers in the U.S. Key Questions: • Is there a single reimbursement pathway for an IVD in the European Union? • Which national bodies decide if your IVD gets reimbursed in Germany and France? • How did the 2011 AMNOG act in…