Background:
The EU’s SoHO Regulation (2024/1938), which entered into force on 6 August 2024, will apply fully from 7 August 2027. This Regulation establishes a uniform legal framework across the EU/EEA for the quality, safety, and traceability of Substances of Human Origin (SoHO) — including sperm, oocytes, embryos, and related reproductive materials used in MAR. It replaces the Tissues and Cells Directive (2004/23/EC).
Scope & Definitions:
Reproductive SoHO: Sperm, oocytes, embryos, ovarian and testicular tissue.
Applies to: Third-party donors, recipients of SoHO, and offspring born via MAR.
Within-relationship use (e.g., partner sperm) is excluded from donor regulations, though the female partner is still a ‘recipient’.
Affected Entities:
SoHO Entities: Any clinic/lab involved in donor testing, processing, storage, or application.
SoHO Establishments: Entities performing processing + storage, import/export, or release (e.g., IVF labs and gamete banks). Subject to regular inspections and authorisation.
(most entities that currently operate as tissue establishments under the Tissues and Cells Directive will
match these definitions. Typical examples of SoHO establishments are IVF laboratories and gamete banks).
Data Reporting:
SoHO entities will have the obligation to send an annual report with summary data on their SoHO activities to their competent authorities via the EU SoHO platform before 30 June of the subsequent year. Competent authorities can also allow SoHO entities to send their data to them via a national or international registry.
Reporting of summary data is mandatory for SoHO entities carrying out the following activities:
– SoHO donor registration
– collection, distribution, import, export and human application
EuMAR Registry:
ESHRE is currently building the EuMAR registry, a European cycle-by-cycle registry of MAR
treatments. This registry is hosted by ESHRE and separate from the EU SoHO platform. Data
submission to EuMAR will not be mandatory, but EuMAR might be able to take over the
mandatory activity data submission for MAR centres in the future, if competent authorities in
their Member State allow this. For more information on EuMAR, please visit www.eshre.eu/EuMAR
Donor Protection Measures:
– Obtain informed consent covering risks, use, and data/privacy.
– Ensure donation is voluntary and non-remunerated (except for capped reimbursement/ compensation under national law).
– Evaluate donor health, ensure safety of the collection process, and monitor post-donation outcomes (especially for oocyte donors).
– Prevent over-donation using national or EU registries.
Recipient and Offspring Protections:
– Prevent communicable disease transmission through testing, deferrals, and sperm processing.
– Minimize genetic risk by reviewing donor/recipient family history and applying genetic testing protocols.
– Protect against: contamination, toxic reagent exposure, reduced efficacy of SoHO, immune reactions or unintended fertilization.
Vigilance & Reporting:
– Detect, document, and report Serious Adverse Events (SAE) and Serious Adverse Reactions (SAR) — including OHSS, genetic transmission to offspring, gamete mix-ups.
– Investigate incidents and share alerts with other clinics or countries if relevant.
Traceability:
– All reproductive SoHO must be traceable for 30 years.
– Use of unique, non-identifying codes is required (including Single European Code for cross-entity transfers).
Clinical Authorisation & Reporting:
– SoHO Preparations (e.g., gametes subject to advanced processing) require prior authorisation and benefit-risk evaluation.
– Annual activity reports (donor stats, applications, etc.) must be submitted via the EU SoHO Platform or national registries.
Key Action Points for MAR Professionals:
1. Register your entity with the national or EU SoHO platform.
2. Update SOPs for donor screening, gamete processing, and traceability.
3. Train staff on SAR/SAE reporting and new documentation requirements.
4. Coordinate with national authorities for inspections, authorisations, and updates.
5. Monitor compliance with evolving ECDC/EDQM guidance.
The full report of ESHRE on the topic as well as other interesting fact sheets within ART can be found here: https://www.eshre.eu/Europe/Factsheets-and-infographics?utm_source=facebook&fbclid=IwY2xjawJcaQtleHRuA2FlbQIxMAABHVkG9rdTd9OOiLi_BmxGYkZjEaiVZQbamSV_LrAqqP2zNzRWSFRAW3stRw_aem_3SRNu-S7WrRf3HDRHSl4Tw