Market Access Strategy for Medical Devices in Europe
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Publication Digest: Institutionalization of Health Technology Assessment of medical devices: a cluster analysis of EU, EEA, and EFTA countries
MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest.
In a recent publication, Nurchis et al. conducted a comparative analysis of how EU, European Economic Area, and European Free Trade Association countries have institutionalized health technology assessment for medical devices (HTA-MD).
Using a 16-element analytical framework and hierarchical cluster analysis, the authors identified three models of HTA-MD governance across 21 countries: (1) regulatory systems with legally binding assessments that directly inform reimbursement, (2) mixed models combining regulatory roles, expert collaboration, formal prioritization, and Horizon Scanning, and (3) advisory systems where assessments are non-mandatory and have limited policy impact. The authors emphasized the need for prioritization processes, enhancing collaboration between assessment centers, and strengthening the link between HTA results and reimbursement decisions.
Access the full-text article here.