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

Health Policy and Technology

Volumn 3, Issue 4, 2014, Pages 253-263

  Krüger, Lisa J ^a,b   Evers, Silvia M A A ^a   Hiligsmann, Mickael ^a   Wild, Claudia ^b  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b LUDWIG BOLTZMANN INSTITUTE FOR LUNG VASCULAR RESEARCH   (Austria)

Author keywords

Authorization; Evidence requirements; HTA health technology assessment; Medical device regulation; Reimbursement

Indexed keywords

ARTICLE; AUSTRALIA; CANADA; DEVICE APPROVAL; DEVICE SAFETY; ECONOMIC ASPECT; EUROPE; EVIDENCE BASED MEDICINE; GOVERNMENT REGULATION; HEALTH CARE POLICY; MARKETING; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; REIMBURSEMENT; RISK ASSESSMENT; STANDARDIZATION; UNITED STATES;

EID: 84919418584     PISSN: 22118837     EISSN: 22118845     Source Type: Journal    
DOI: 10.1016/j.hlpt.2014.08.005     Document Type: Article

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