128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research
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.
Authors
- Josep M. Tabernero (ORCID: https://orcid.org/0000-0002-2495-8139)
- Ana Vivancos (ORCID: https://orcid.org/0000-0003-2888-6512)
- Paula Chiquillo
- Elena Garralda
- Laia Catalan
- O. Padros
- N. Farràs
- M. Rotxes Costa
- A. Hernando Calvo
- C. Perez Alonso
- L. Cruz Ballús
- E. Banus
- L. Saucedo Martin
- S. Vázquez Vinuesa
- E. Aliende
- A. Meire Barrio
- A. Matres Rojo
- A. Almodovar
- S. Aguilar Izquierdo
- E. Felip
Institutions
- Hebron University (PS)
- Vall d'Hebron Institut de Recerca (ES)
- Vall d'Hebron Hospital Universitari (ES)
- CIBBIM-Nanomedicine (ES)
Publication Details
- Journal
- ESMO Open
- Published
- 2026-04-01
- DOI
- https://doi.org/10.1016/j.esmoop.2026.106270
- Primary Topic
- Advances in Oncology and Radiotherapy
- Type
- article
- Field-Weighted Citation Impact
- 0.00