Publication Digest: Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping review

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, Bralić et al. conducted a scoping review of methodologies for generating and evaluating evidence for high-risk and innovative medical devices and in vitro diagnostics in the EU. The review included 98 studies and found that robust evaluation requires a combination of randomized trials, observational studies, registries, real-world evidence, and post-market surveillance. The authors also identified methodological limitations, inconsistent practices, and gaps in regulatory harmonization, emphasizing the need for a continuous and strategically planned lifecycle approach to evidence generation.

Access the full-text article here.