EU HTA Publication Digest: Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union

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, Gupte et al. conducted a review of accelerated approval pathways for medical devices in the United States and the European Union. The authors found that while the US Breakthrough Devices Program granted marketing authorization to just 12.3% of 1,041 designated devices between 2015 and 2024, approval was achieved substantially faster than through standard routes. In the EU, where no specific accelerated pathway exists, newly introduced Medical Device and Health Technology Assessment Regulations aim to harmonize approvals, with joint clinical assessments set to begin in 2026. The authors highlight that aligning regulatory, funding, and coverage policies is essential for device accessibility, and call for global convergence of standards and post-market surveillance to balance innovation with patient safety.

Access the full-text article here.