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Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

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  • Beck, ACC
  • Retèl, VP
  • Bhairosing, PA
  • van den Brekel, MWM
  • van Harten, WH

Abstract

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU.

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  • Beck, ACC & Retèl, VP & Bhairosing, PA & van den Brekel, MWM & van Harten, WH, 2019. "Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review," Health Policy, Elsevier, vol. 123(12), pages 1185-1198.
    • Handle: RePEc:eee:hepoli:v:123:y:2019:i:12:p:1185-1198
    DOI: 10.1016/j.healthpol.2019.10.002
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    References listed on IDEAS

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    8. Oriana Ciani & Britni Wilcher & Anoukh Giessen & Rod S. Taylor, 2017. "Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments," Health Economics, John Wiley & Sons, Ltd., vol. 26, pages 13-29, February.
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    2. Claus Zippel & Sabine Bohnet-Joschko, 2021. "Rise of Clinical Studies in the Field of Machine Learning: A Review of Data Registered in ClinicalTrials.gov," IJERPH, MDPI, vol. 18(10), pages 1-14, May.

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