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

A.C.C. Beck*, V.P. Retèl, P.A. Bhairosing, M.W.M. van den Brekel, W.H. van Harten

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

12 Citations (Scopus)
25 Downloads (Pure)


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. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians’ prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access.

Original languageEnglish
Pages (from-to)1185-1198
Number of pages14
JournalHealth policy
Issue number12
Early online date19 Oct 2019
Publication statusPublished - Dec 2019


  • Barriers
  • Facilitators
  • Medical device
  • Patient access
  • Regulation
  • Reimbursement
  • n/a OA procedure


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