The progressive improvements of scientific research in the development of technologies embedded in medical devices (MD) is reflected in the continuous growth of the introduction rates of these technologies. These innovative MD need to be evaluated through a decisional process capable to include a broad range of criteria (e.g., clinical value, safety, effectiveness, economic/organizational impact, and burdens the end user suffers).

Health Technology Assessment (HTA) allows to effectively tackle such complex decision process: indeed, through the use of Multi-Criteria Decision Analysis (MCDA), HTA can include a multiplicity of assessment aspects. Hence, in recent years, experiments on approaches that combine HTA and MCDA have been investigated, also in the field of micro-level HTA (or local/hospital-based HTA), to support local decision-makers in selecting MD.

However, locally led HTA tools based on MCDA differ in terms of both the MCDA technique, and the utilized criteria (strictly tailored to the specific MD to evaluate). Albeit partially due to the necessity to cater to specific needs of the local contexts, such diversity is due to a lack of clear guidance at the (inter)national level. This is because, firstly, only a small proportion of MD used in hospitals are actually assessed by national health authorities. Secondly, HTA of MD has been largely developed with the evaluation of drugs in mind, so overlooking differences between drugs and devices, and neglecting pivotal aspects of MD.

Hence, the practical implementation of HTA tools has been seriously jeopardized, since decision makers are required to identify new criteria each time they have to assess new devices, propose adequate measurement scales, validate them and select the MCDA technique.

According to the EU Parliament recommendation (adopted by EUnetHTA) to promote convergence in HTA tools/procedures/methodologies, this project answers the call for a standardized tool for micro-level HTA based on MCDA.