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. CONCLUSION: 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.