Testing a new taxonomic model for the assessment of medical devices: Is it plausible and applicable? Insights from HTA reports and interviews with HTA institutions in Europe

Europe is one of the biggest markets for Medical devices (MDs), which encompass a broad and heterogeneous range of technologies. They include ‘[…] any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis , treatment or alleviation of disease […]’ [1]. To date, several classification systems for MDs have been developed, ranging from those aiming to facilitate market approval by categorizing MDs according to the degree of risk they pose for patients [1,2], to those used for procurement purposes, w hich take a perspective relevant to pricing and reimbursement decisions [3–5].

Source: Health Policy - March 14, 2018 Category: Health Management Authors: Sabine Fuchs, Britta Olberg, Matthias Perleth, Reinhard Busse, Dimitra Panteli Source Type: research