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Published on: October 24, 2025
A new regulatory framework: impact of the SoHO Regulation for medically assisted reproduction
Fiorenza Bariani1, Alessandra Alteri1, Liliam Santilli1
1Italian National Transplant Centre, National Institute of Health, Rome, Italy.
Abstract:
Regulation (EU) 2024/1938 on Substances of Human Origin (SoHO), adopted in June 2024 and entering into application from 7 August 2027, establishes a unified and legally binding framework for all human-derived materials used in clinical practice, explicitly encompassing gametes and embryos. By replacing the previous EU Tissues and Cells Directives, it introduces harmonized standards for authorization, vigilance, and traceability, while reinforcing donor, recipient, and offspring protection. This commentary examines the main regulatory innovations relevant to medically assisted reproduction (MAR) and critically assesses their expected impact through a SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis. The SoHO Regulation offers an unprecedented opportunity to strengthen safety, quality, and ethical governance in MAR through evidence-based oversight and harmonized technical standards. However, its implementation may also generate significant administrative burden, challenges in proportionality, and potential delays in innovation. Overall, the SoHO Regulation represents a milestone for reproductive medicine, offering the chance to elevate safety and equity across Europe, provided its implementation is proportionate and supported by adequate guidance and collaboration among competent authorities and MAR professionals.
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