EU Joint Clinical Assessment: First High-Risk Medical Devices Selected Under HTAR

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-23

On October 6, 2026, the European Commission selected the first group of high-risk medical devices to undergo a Joint Clinical Assessment (JCA) under the new EU Health Technology Assessment Regulation (HTAR). This episode explains what this pivotal moment means for medical device manufacturers, which device categories are impacted, and how the JCA will reshape the pathway for pricing, reimbursement, and market access across the European Union. We discuss the heightened evidence requirements and provide practical steps for regulatory and market access teams to prepare for this new centralized assessment system. Key Questions: - What is the EU Joint Clinical Assessment (JCA) and...