The European Committee on Organs, Tissues and Cells (CD-P-TO) of the Council of Europe, with Secretariat support from the European Directorate for the Quality of Medicines & HealthCare (EDQM), has published a position paper entitled “The regulatory approach to ex situ manipulation of human organs”. Adopted by the CD-P-TO on 8 October 2026 and published by the EDQM on 23 October 2026, the policy document proposes a European regulatory approach for human organs that undergo ex situ (outside-the-body) assessment, preservation and interventions beyond conventional preservation before transplantation. Its central...