Health technology assessment for medical devices in Europe. What must be considered.
OBJECTIVE
To inform about the specifics of medical devices and the resulting consequences for health technology assessment (HTA) and to present the European industry position on this topic.


METHODS
The paper is based on an intensive debate within Eucomed, the European trade association in the field of medical devices, informed by an HTA Experts Group, comprising experts from within and outside the medical device industry.


RESULTS
Based on the specifics of medical devices, there are a number of methodologic considerations that require a tailored HTA, differing from the approach taken for, for example, pharmaceutical products. These differences have an impact on the selection of the technology, the timing of the assessment, the study design, and the patient population.


CONCLUSIONS
The European medical device industry can commit to an HTA that takes into consideration the specifics of medical technologies, which is appropriate and fair, and which is done under full participation of industry. Under these circumstances HTA can be a useful tool to support rational decision making in health care.
Siebert
Markus
M
Clauss
Louis Christian
LC
Carlisle
Malcolm
M
Casteels
Brigitte
B
de Jong
Peter
P
Kreuzer
Michael
M
Sanghera
Sukh
S
Stokoe
Graham
G
Trueman
Paul
P
Lang
Antoinette Wenk
AW
D003299:Cooperative Behavior; D003362:Cost-Benefit Analysis; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005062:European Union; D019981:Health Care Sector; D006801:Humans; D007221:Industry; D016134:Organizational Policy; D016032:Randomized Controlled Trials as Topic; D013673:Technology Assessment, Biomedical / Q000379:methods*