Objectives: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. Methods: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. Results: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. Conclusions: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.
Keywords: Health technology assessment, Medical devices, ClassificationHealth technologies such as medical devices are an essential part of health care. The European Union defines a medical device as " [ . . . ] any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories [ . . . ]" (1), which includes a broad range of different products for purposes such as prevention, diagnosis, monitoring, treatment, alleviation of disease, or compensation for an injury or handicap (1). Many of these devices have led to important improvements in diagnosis and treatment of diseases such as better health outcomes in terms of higher life expectancy and/or better quality of life (2-4). However, their rapid pace of innovation might also be associated with risks (5) and cause harm to patients. Recent examples arising from the use of medical devices include recalls of specific types of breast implants (6), artificial hips (7), and implantable cardioverter-defibrillators (8). Furthermore, fast-paced innovation is accompanied by rising health expenditures (9;10). The combined imperatives of patient benefit and safety as well as cost containment have led many countries to introduce regulatory instruments to identify technologies that minimize risk and ensure value and value for money.There are two approaches to regulate medic...