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2. In the course of the living SoHO donor health evaluations referred to in paragraph 1, point (e), of this Article, SoHO entities shall conduct interviews with the SoHO donors and gather information concerning the SoHO donors’ present and recent state of physical, and, where appropriate, mental health and their health histories to assure the safety of the SoHO donation process for those SoHO donors. SoHO entities may perform additional tests as part of the SoHO donor health evaluations. They shall perform such tests in cases where evaluations indicate that additional tests are necessary to establish the eligibility of those SoHO donors from the perspective of their own protection. The physician referred to in Article 50 shall approve the procedure and criteria for SoHO donor health evaluations.

4. SoHO entities that collect SoHO from living SoHO donors that are subjected to a surgical procedure in order to donate, or that are treated with prescribed medication to facilitate SoHO donation, shall ensure that the plan for monitoring the SoHO donor’s health after SoHO donation, as referred to in paragraph 1, point (j), is proportionate to the risks associated with the SoHO donation. SoHO entities shall include in the plan the time period during which the monitoring shall continue.

5. The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation in cases where additional standards are needed in order to ensure the protection of SoHO donors.

6. Where, in the case of risk to the safety of living SoHO donors, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.

1. Where SoHO are collected from SoHO donors, regardless of whether or not the SoHO donor is related to the intended recipient, SoHO entities shall:

(a) meet all applicable consent or authorisation requirements in force in the Member State concerned;

(b) provide SoHO donors or, where applicable, any persons granting consent on their behalf, in accordance with national legislation, with:

(i) the information referred to in Article 55 in a way that is adequate in view of their capacity to understand it;

(ii) the contact details of the SoHO entity responsible for collection from which they can request further information, if needed;

(c) safeguard the rights of the living SoHO donor to physical and mental integrity, to non-discrimination, to privacy and to the protection of the personal data, including health data concerning them, in accordance with Regulation (EU) 2016/679;

(d) ensure that SoHO donation is voluntary and unpaid, pursuant to Article 54;

(e) verify the eligibility of the living SoHO donor on the basis of a donor health evaluation that aims to identify, with a view to minimising, any risk that the SoHO collection might pose to the SoHO donor’s health;

(f) document the results of the living SoHO donor health evaluation;

(g) communicate and clearly explain the results of the living SoHO donor health evaluation to the living SoHO donor or, where applicable, any persons granting consent on their behalf, in accordance with national legislation;

(h) identify and minimise any risks to the health of the living SoHO donor during the SoHO collection procedure, including exposure to reagents or solutions that might be harmful to health;

(i) in cases where SoHO can be donated repeatedly, and frequent donation might negatively influence the living SoHO donor’s health, verify, by means of registries, as referred to in paragraph 3 of this Article, that living SoHO donors are not donating more frequently than indicated as safe in technical guidelines referred to in Article 56(4) and monitor relevant health indicators to evaluate whether their health is not compromised;

(j) in cases where SoHO donation implies a significant risk to a living SoHO donor, develop and implement a plan for monitoring the SoHO donor’s health after donation as referred to in paragraph 4;

(k) in the case of an unrelated SoHO donation, refrain from revealing the SoHO donor’s identity to the recipient or to the offspring from medically assisted reproduction, apart from in circumstances where such information exchange is permitted in the Member State concerned.

3. SoHO entities that collect SoHO from living SoHO donors as referred to in paragraph 1, point (i), of this Article shall register such SoHO donors in a SoHO entity registry or, where available, in national or recognised international registries, to verify donation frequency. SoHO entity-level and national registries shall have the possibility of interconnectivity with other such registries. Where a SoHO entity-level registry or a national registry is used, and where the circumstances point to a risk that a SoHO donor is donating too frequently in more than one SoHO entity located in one or more Member States, SoHO entities shall verify whether this is the case by consulting with interconnected SoHO donor registries on a case-by-case basis. SoHO entities shall be in a position to demonstrate to their SoHO competent authorities, on request, that an appropriate procedure that mitigates such risk is in place. Such procedures shall take into account the technical guidelines referred to in Article 56(4).