128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research
Year: 2026
Type: article
Abstract: The IVDR implementation has added complexity to CT submissions by requiring additional authorization of performance studies for non-CE-marked diagnostic tests. This study analyzes the impact of the IVDR in a reference oncology CT unit.
Source: ESMO Open
Authors: A. Matres Rojo, N. Farràs, P. Chiquillo, M. Rotxes Costa, C. Perez Alonso, L. Cruz Ballús, S. Vázquez Vinuesa, E. Aliende, L. Saucedo Martin, E. Banus, A. Almodovar, L. Catalan, A. Meire Barrio, O. Padros, A. Vivancos, S. Aguilar Izquierdo, J. Tabernero, E. Felip, A. Hernando Calvo, E. Garralda
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,910
OpenAlex ID: W7147476319
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