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New Substance of Human Origin Regulation

Posted on 06.06.2024

MedTech Europe welcomes the EU Council’s final adoption of the new Substance of Human Origin (SoHO) Regulation, a pivotal step in enhancing the safety and quality of blood, tissues, and cells across Europe. 

This regulation, replacing outdated directives, fortifies safety protocols, safeguards donors and recipients, and facilitates cross-border movement of SoHOs. It emphasises donor and recipient safety and addresses supply shortages. We commend, in particular, the recognition of compensation under specific conditions, reinforcing ethical healthcare practices. 

For more information, please contact Carlos Pérez Barrionuevo, Manager Medical Devices.