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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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    1. Finocchiaro Castro, Massimo & Guccio, Calogero & Pignataro, Giacomo & Rizzo, Ilde, 2014. "The effects of reimbursement mechanisms on medical technology diffusion in the hospital sector in the Italian NHS," Health Policy, Elsevier, vol. 115(2), pages 215-229.
    2. David Moher & Alessandro Liberati & Jennifer Tetzlaff & Douglas G Altman & The PRISMA Group, 2009. "Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement," PLOS Medicine, Public Library of Science, vol. 6(7), pages 1-6, July.
    3. Fuchs, Sabine & Olberg, Britta & Panteli, Dimitra & Perleth, Matthias & Busse, Reinhard, 2017. "HTA of medical devices: Challenges and ideas for the future from a European perspective," Health Policy, Elsevier, vol. 121(3), pages 215-229.
    4. Cappellaro, Giulia & Fattore, Giovanni & Torbica, Aleksandra, 2009. "Funding health technologies in decentralized systems: A comparison between Italy and Spain," Health Policy, Elsevier, vol. 92(2-3), pages 313-321, October.
    5. Oriana Ciani & Britni Wilcher & Anoukh van 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(S1), pages 13-29, February.
    6. Schreyögg, Jonas & Bäumler, Michael & Busse, Reinhard, 2009. "Balancing adoption and affordability of medical devices in Europe," Health Policy, Elsevier, vol. 92(2-3), pages 218-224, October.
    7. Martelli, Nicolas & van den Brink, Hélène, 2014. "Special funding schemes for innovative medical devices in French hospitals: The pros and cons of two different approaches," Health Policy, Elsevier, vol. 117(1), pages 1-5.
    8. Olberg, Britta & Perleth, Matthias & Busse, Reinhard, 2014. "The new regulation to investigate potentially beneficial diagnostic and therapeutic methods in Germany: Up to international standard?," Health Policy, Elsevier, vol. 117(2), pages 135-145.
    9. 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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