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1. When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Article 53 or 55, in order to ensure convergent and high levels of SoHO donor protection, the Commission may adopt implementing acts setting out particular procedures to be followed and applied to meet such standard, or element thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

2. On duly justified imperative grounds of urgency relating to a risk to SoHO donor health, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 79(3).

3. The implementing acts adopted in accordance with paragraphs 1 and 2 of this Article shall also apply to SoHO entities when they apply the standards concerning SoHO donor protection, or elements thereof, as referred to in Articles 53 and 55.

4. For those standards concerning SoHO donor protection, or elements thereof, for which no implementing act has been adopted, SoHO entities shall take into account:

(a) the most recent technical guidelines, as indicated on the EU SoHO Platform, as follows:

(i) published by the ECDC concerning the prevention of communicable disease transmission;

(ii) published by the EDQM concerning SoHO donor protection other than from transmission of communicable diseases;

(b) other guidelines, adopted by Member States, as referred to in Article 27(6), point (b);

(c) other guidelines or technical methods, applied in specific circumstances, as referred to in Article 27(6), point (c).

5. In the cases referred to in paragraph 4, point (a), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the technical guidelines referred to in paragraph 4, point (a), of this Article.

6. In the cases referred to in paragraph 4, point (b), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall demonstrate to their SoHO competent authorities, for each of the standards or elements thereof, which and to what extent they follow the guidelines referred to in paragraph 4, point (b), of this Article.

7. In the cases referred to in paragraph 4, point (c), of this Article, for the purposes of Article 28 in conjunction with Article 27, SoHO entities shall provide during inspection a justification to their SoHO competent authorities for each specific standard or element thereof, that the other guidelines are adequate to achieve the level of quality and safety set out in that standard. That justification may be based on a documented demonstration of equivalence with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 4, point (a), of this Article.

Where other technical methods are applied, SoHO entities shall perform a risk assessment to demonstrate that the technical methods applied achieve a high level of protection of SoHO donors, and they shall record the practice followed to establish such technical methods. They shall make the assessment and record available for review by their SoHO competent authorities during inspection or on specific request of the SoHO competent authorities.