Institutionalization of Health Technology Assessment of medical devices: a cluster analysis of EU, EEA, and EFTA countries.

ABSTRACT:

Objectives

Health technology assessment of medical devices (HTA-MDs) presents unique challenges compared to pharmaceuticals. Total MD expenditure continues to grow in Europe, and countries typically conduct their own HTA-MDs evaluations, with varying institutionalization arrangements. European Union's (EU's) HTA Regulation aims to establish collaborative clinical assessments across Member States, potentially expediting the path from EU safety certification of MDs to pricing and reimbursement decisions. This study aims to identify emergent configurations among institutionalizations of HTA-MDs in the EU, European Economic Area (EEA), and European Free Trade Association (EFTA) countries.

Methods

Publicly available data were cross-sectionally collected for EU, EEA, and EFTA coun

SUBMITTER: Nurchis MC 

PROVIDER: S-EPMC12303692 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature