128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research

20260 citationsJournal Articlegold Open Access

Authors

A. Matres Rojo · Vall d'Hebron Institut de Recerca

N. Farràs · Hebron University

Paula Chiquillo · Vall d'Hebron Institut de Recerca

M. Rotxes Costa · Vall d'Hebron Institut de Recerca

C. Perez Alonso · Hebron University

L. Cruz Ballús · Hebron University

S. Vázquez Vinuesa ·

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.

Topics & Keywords

Advances in Oncology and Radiotherapy Radiology practices and education Global Cancer Incidence and Screening

Publication Details

Published in: ESMO Open

Volume 11, pp. 106270-106270

DOI: 10.1016/j.esmoop.2026.106270

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128MO Impact of in-vitro diagnostic regulation (IVDR) implementation on authorization timelines and access to oncology clinical research

Authors

Abstract

Topics & Keywords

Publication Details