Regulatory and HTA early dialogues in medical devices

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

9 Citations (Scopus)
21 Downloads (Pure)

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. Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe. Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues. Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially. Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers.

Original languageEnglish
Pages (from-to)1322-1329
Number of pages8
JournalHealth Policy
Volume125
Issue number10
DOIs
Publication statusAccepted/In press - 24 Jul 2021

Bibliographical note

Funding Information:
This project received funding from the European Commission's Horizon 2020 research and innovation programme under grant agreement #779306 (COMED—Pushing the Boundaries of Cost and Outcome Analysis of Medical Technologies). The results reflect the authors’ views only. The European Commission is not responsible for any use that may be made of the information contained in this paper.

Publisher Copyright:
© 2021 The Author(s)

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