Bioprinted Constructs in the Regulatory Landscape: Current State and Future Perspectives

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Bioprinting has become one of the leading topics in biomedical research in the past decade, as demonstrated by the great surge in publications and proliferation of bioprinting facilities worldwide. Bioprinting has gained widespread popularity because of its potential to replicate complex biological structures, revolutionize in vitro testing, and tissue engineering. However, the clinical translation of bioprinted products remains a challenge. The regulatory approval of tissue-engineered products requires extensive preclinical and clinical trials with different standards worldwide. The regulatory landscape for bioprinted products is examined in the European Union, United States, China, and Australia. The current regulatory status of bioprinting is traced by exploring parallels with existing categories such as 3D printed medical devices, injectable hydrogels, and tissue engineering products. This perspective provides a comprehensive overview of the current state and regulatory landscape of bioprinted constructs, envisioning challenges, and strategies for their future integration into clinical practice.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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