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
Krüger LJ, Wild C
Record ID 32013000933
English
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' recommendations:
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.
Details
Project Status:
Completed
Year Published:
2013
URL for published report:
http://eprints.hta.lbg.ac.at/1017
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Austria
MeSH Terms
- Equipment and Supplies
Contact
Organisation Name:
Ludwig Boltzmann Institute for Health Technology Assessment
Contact Address:
Ludwig Boltzmann Institute for 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
Contact Name:
tarquin.mittermayr@aihta.at
Contact Email:
office@aihta.at
Copyright:
Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.