New Organs on Command: The Regulatory Prospects of 3D Bioprinting Technology in the European Union

This article examines the evolving legal landscape of bioprinting in the European Union, focusing on the regulatory challenges posed by the hybrid nature of bioprinted products. These constructs – simultaneously biological and synthetic – defy conventional legal classifications and are conceptualised here as biosthetics. The analysis explores how existing EU regulatory instruments – including the ATMP Regulation, MDR, GDPR and SoHO Regulation – apply to bioprinting technologies across research and development as well as clinical implementation. The article argues that current frameworks, while comprehensive, remain fragmented and insufficiently adaptive to address the ontological and operational complexities of biosthetics entities. Three regulatory scenarios are presented: continued reliance on mode-of-action classification, incremental amendments to existing laws and the development of a novel regulatory model tailored to bioprinting. Ultimately, the article advocates for a paradigm shift towards anticipatory, participatory and ethically grounded governance that can respond to the challenges and promises of biomedical technologies in the biosthetics age.