EU HTA Publication Digest: Classification grid and evidence matrix for evaluating digital medical devices under the European Union landscape

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. 

In a recent publication, Boers et al. introduced the Common European Classification Grid (CEUGrid-DMD) and an Evidence Matrix to harmonize the evaluation of digital medical devices (DMDs) across the EU. The framework was developed through comparative mapping of national schemes, a survey of HTA bodies in nine countries, and expert workshops. It establishes five functional categories of DMDs and links them to four taxonomy groups with corresponding evidence domains. These tools aim to reduce heterogeneity in national assessments and enable joint EU-level evaluations under the new HTA Regulation.

Access the full-text article here.