Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Krüger LJ, Wild C. Evidence requirements for the authorization and reimbursement of high-risk medical devices in the USA, Europe, Australia and Canada: an analysis of seven high-risk medical devices
. Vienna: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBIHTA). HTA-Projektbericht 73. 2013 Authors' objectives Medical devices play an important role in healthcare systems. In the last decade, public awareness has been raised because of unsafe and ineffective high-risk devices entering markets. Consequently, evidence
requirements for the market authorization process of medical devices may not be enough to ensure high-quality and safe provision of care.
This research first explores the authorization systems for high-risk medical devices in four selected regions (USA, Canada, Australia and Europe). Secondly, it analyzes the clinical evidence accessible at time of market approval and decision support (HTA) for reimbursement for seven selected high-risk medical devices. Authors' conclusions The results support a change in the European authorization system towards a transparent and evidence-based regulation process. Conditional coverage or coverage under evidence development is applied
as instrument to close the gap between immature data and reimbursement requirements. Indexing Status Subject indexing assigned by CRD MeSH Device Approvals; Equipment and Supplies Language Published English Country of organisation Austria English summary An English language summary is available. Address for correspondence Ludwig Boltzmann Institute fuer Health Technology Assessment (LBI-HTA), Garnisongasse 7 rechte Stiege Mezzanin (Top 20), 1090 Vienna, Austria. Tel: +43 1 236 8119 - 0 Fax: +43 1 236 8119 - 99 AccessionNumber 32013000933 Date abstract record published 12/12/2013 |