Divergent evidence requirements for authorization and reimbursement of high-risk medical devices – The European situation

•Huge differences in evidence requirements for regulatory processes for medical devices exist.•Devices are entering the market 2–5 years earlier in Europe compared to the other regions.•Harmonizing the evidence requirements for regulatory processes for medical devices is essential.

BackgroundUnsafe and dangerous medical devices have entered the European market during the last decade, raising public awareness. Consequently, regulatory processes and their requirements for evidence are under discussion.ObjectiveThis research aims to explore the authorization and reimbursement processes and associated evidence requirements for high-risk medical devices in four regions: Europe, the United States, Australia and Canada.MethodsA literature search in PubMed about the authorization and reimbursement processes in the four regions was performed. Seven high-risk medical devices were selected as examples, and their authorization and reimbursement status were analyzed. Information was extracted from publicly available summaries of the authorization agencies of the regions, from the Controlled Clinical Trial Database, supplemented by information from HTA and reimbursement organizations.ResultsThe evidence required for the authorization and reimbursement processes differs strongly in the four regions regarding the levels of methodology and scrutiny. All seven devices have been authorized in Europe, three in Australia, one in the USA, and one in Canada. Currently none of the devices is recommended for reimbursement in the regions except one, in the USA. Devices that have been authorized in more than one region show that authorization has been two to three years earlier in Europe.ConclusionHuge differences and gaps in the evidence required for market authorization and for reimbursement were observed, especially between the two processes (authorization and reimbursement) in Europe. To ensure the high quality and safe provision of medical devices, harmonization of requirements and transparency in processes are needed.