Systematic ReviewPublished 24 June 2026Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and in vitro diagnostics: a scoping reviewNensi Bralić · Ružica Bandić · Miro Vuković · Danira Matijaca · Renata Valsami · Panagiotis Zoumpoulakis · Kalle Schnitzer · Mari Levula · Risto Roine · Antti Viitala · Antti Pihlava · Olivia McDermott · Ana MarušićFrontiers in Medical Technologydoi 10.3389/fmedt.2026.1857401
ReviewPublished 26 November 2025Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a reviewJoan D’souza · Mukesh Nandave · Ruth BlöchlingerFrontiers in Drug Safety and Regulationdoi 10.3389/fdsfr.2025.1609455