Articles | Frontiers

Systematic Review

Published 24 June 2026

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

Nensi Bralić · Ružica Bandić · Miro Vuković · Danira Matijaca · Renata Valsami · Panagiotis Zoumpoulakis · Kalle Schnitzer · Mari Levula · Risto Roine · Antti Viitala · Antti Pihlava · Olivia McDermott · Ana Marušić

Frontiers in Medical Technology

doi 10.3389/fmedt.2026.1857401