Posted 11 days ago

EU MedTech Market Access Leads - Integrated MDR & HTA Evidence Design

Quick question for the MedTech market access community. EU HTA Regulation 2021/2282 entered application January 2025. For those of you who have been through both Notified Body and HTA evidence cycles in the last 18 months: Are most sponsors still treating regulatory and market access evidence as separate workflows with separate teams? Genuinely curious. Working on a piece about integrated MDR and market access evidence design that publishes next 2 weeks. Would love to incorporate real perspectives from people who have lived through this. DM me if you'd like a preview before it goes live. #EUMDR #HTAR #MarketAccess #PMCF #MedicalDevices
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