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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