Regulatory and HTA early dialogues in medical devices

Carl Blankart, Florian Dams, Hannah Penton, Zoltán Kaló, Antal Zemplényi, Kosta Shatrov, Rowan Iskandar and Carlo Federici

Health Policy, 2021, vol. 125, issue 10, 1322-1329

Abstract: Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence.

Date: 2021
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Persistent link: https://EconPapers.repec.org/RePEc:eee:hepoli:v:125:y:2021:i:10:p:1322-1329

DOI: 10.1016/j.healthpol.2021.07.010

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