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1. SoHO competent authorities of the Member States where SoHO establishments are located shall carry out inspections of those SoHO establishments, and, where applicable, of SoHO entities or third parties contracted by SoHO establishments.

2. SoHO competent authorities shall carry out the following inspections of SoHO establishments, as appropriate:

(a) announced routine system inspections;

(b) announced or unannounced inspections, in particular for the investigation of fraudulent or other illegal activities, or on the basis of information that indicates possible non-compliance with this Regulation;

(c) announced or unannounced inspections targeted at a specific activity or topic as provided for in Article 20(6), Article 26(5), Article 29 and Article 33(6).

3. SoHO competent authorities that identify during inspections cases of non-compliance with this Regulation may include follow-up to those inspections, where necessary and proportionate, to verify that SoHO establishments have undertaken appropriate corrective and preventive actions.

4. SoHO competent authorities shall carry out on-site inspections. However, exceptionally, SoHO competent authorities may conduct inspections, in full or in part, by virtual means, or by remote document review, provided that:

(a) such inspection modes do not pose a risk to the quality and safety of SoHO;

(b) such inspection modes do not prejudice the effectiveness of inspections;

(c) protection of SoHO donors, SoHO recipients or offspring from medically assisted reproduction is respected; and (d) the maximum interval between two on-site inspections pursuant to paragraph 9 is not exceeded.

5. SoHO competent authorities shall ensure that inspections are carried out by inspectors who meet the requirements set out in Article 30.

6. The inspections shall include the verification that SoHO establishments comply with the standards, or elements thereof, set out in Chapters VI and VII. In cases where the SoHO establishments follow:

(a) the technical guidelines published by the ECDC and by the EDQM referred to in Article 56(4), point (a), and Article 59(4), point (a), as applicable, the inspectors shall consider the standards set out in this Regulation to be met, insofar as they are addressed by such guidelines;

(b) other guidelines as referred to in Article 56(4), point (b), and Article 59(4), point (b), adopted by the Member State in accordance with paragraph 7 of this Article, the inspectors shall consider the standards set out in this Regulation to be met, insofar as they are addressed by such guidelines;

(c) guidelines other than those referred to in point (a) or (b) of this paragraph, or other technical methods that are not addressed in guidelines, applied in specific circumstances, as referred to in Article 56(4), point (c), and Article 59(4), point (c), the inspectors shall evaluate the steps taken by the SoHO establishments to ensure the adequacy of such guidelines or technical methods, and their compliance with the standards set out in this Regulation; for that evaluation, the SoHO establishments shall provide the inspectors with all the necessary information, pursuant to Article 56(7) and Article 59(7).

9. Following the inspection referred to in Article 25(2), point (e), SoHO competent authorities shall carry out periodic inspections pursuant to paragraph 2, point (a), of this Article, so that the interval between two on-site inspections shall not exceed, in any event, 4 years. The frequency of inspections shall take account of:

(a) identified risks associated with the type of SoHO that are subject to the SoHO establishment authorisation and the SoHO activities carried out;

(b) the SoHO establishments’ past record as regards the outcome of previous inspections and their compliance with this Regulation;

(c) the certification or accreditation by international bodies, where relevant;

(d) the reliability and effectiveness of the quality management system referred to in Article 37.

10. Following each inspection, the SoHO competent authorities shall draw up a report on the findings of the inspection and provide it to the SoHO establishment concerned. Where the result of the inspection so requires, the SoHO competent authorities shall, as appropriate, set out any corrective or preventive action needed or shall request the SoHO establishment to respond with a proposal for such actions, with associated dates for completion.

11. For the purpose of inspections referred to in paragraph 1 of this Article, SoHO competent authorities shall take into account the relevant best practices on inspections documented and published by the SCB, as referred to in Article 69(1), point (d).

12. The Commission may adopt implementing acts concerning technical elements of the procedures to be followed for inspections of SoHO establishments. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

7. When adopting the guidelines referred to in paragraph 6, point (b), of this Article, the Member State shall, prior to the inspection, verify and document that those guidelines are adequate to achieve compliance with the standards set out in Chapters VI and VII and shall make those guidelines available on the EU SoHO Platform. Those guidelines shall be deemed to be adequate to achieve compliance with the standards of this Regulation where they have been established to be equivalent with the technical guidelines published by the ECDC and by the EDQM referred to in paragraph 6, point (a), of this Article.

8. Inspectors shall carry out one or more of the following activities:

(a) inspect premises;

(b) evaluate and verify compliance of the procedures and the SoHO activities performed with the requirements of this Regulation;

(c) examine any documents or other records relating to the requirements of this Regulation;

(d) where applicable, evaluate the design and implementation of the quality management system in place pursuant to Article 37;

(e) evaluate compliance with the vigilance and the traceability systems;

(f) take samples for analysis, copies of documents, and photographs or videos, if required;

(g) evaluate the SoHO entity emergency plan in place in accordance with Article 67, where applicable;

(h) order or propose to the SoHO competent authority, the suspension or cessation of any procedure or activity or impose other measures, where necessary and proportionate to the risk detected; in such case, the inspector shall take all the necessary steps without undue delay.