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Regulatory and HTA early dialogues in medical devices

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

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.

Suggested Citation

  • Blankart, Carl Rudolf & Dams, Florian & Penton, Hannah & Kaló, Zoltán & Zemplényi, Antal & Shatrov, Kosta & Iskandar, Rowan & Federici, Carlo, 2021. "Regulatory and HTA early dialogues in medical devices," Health Policy, Elsevier, vol. 125(10), pages 1322-1329.
    • Handle: RePEc:eee:hepoli:v:125:y:2021:i:10:p:1322-1329
    DOI: 10.1016/j.healthpol.2021.07.010
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    References listed on IDEAS

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    1. Callea, Giuditta & Armeni, Patrizio & Marsilio, Marta & Jommi, Claudio & Tarricone, Rosanna, 2017. "The impact of HTA and procurement practices on the selection and prices of medical devices," Social Science & Medicine, Elsevier, vol. 174(C), pages 89-95.
    2. Maarten J. IJzerman & Hendrik Koffijberg & Elisabeth Fenwick & Murray Krahn, 2017. "Emerging Use of Early Health Technology Assessment in Medical Product Development: A Scoping Review of the Literature," PharmacoEconomics, Springer, vol. 35(7), pages 727-740, July.
    3. Antle, R, 1984. "Auditor Independence," Journal of Accounting Research, Wiley Blackwell, vol. 22(1), pages 1-20.
    4. Fischer, Katharina Elisabeth & Heisser, Thomas & Stargardt, Tom, 2016. "Health benefit assessment of pharmaceuticals: An international comparison of decisions from Germany, England, Scotland and Australia," Health Policy, Elsevier, vol. 120(10), pages 1115-1122.
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    Cited by:

    1. Carlo Federici & Leandro Pecchia, 2022. "Exploring the misalignment on the value of further research between payers and manufacturers. A case study on a novel total artificial heart," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 98-115, September.
    2. Shatrov, Kosta & Blankart, Carl Rudolf, 2022. "After the four-year transition period: Is the European Union's Medical Device Regulation of 2017 likely to achieve its main goals?," Health Policy, Elsevier, vol. 126(12), pages 1233-1240.
    3. Aleksandra Torbica & Rosanna Tarricone & Jonas Schreyögg & Mike Drummond, 2022. "Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project," Health Economics, John Wiley & Sons, Ltd., vol. 31(S1), pages 1-9, September.

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