Chapter I: Antenatal diagnostics: prenatal diagnosis and pre-implantation diagnosis

Cell sampling and the examinations mentioned in article R. 2131-22-2 are carried out under the responsibility of one or more practitioners approved in application of article L. 2131-4-2. They alone are authorised to sign the examination reports.

The practitioner approved for one of the activities mentioned in Article R. 2131-22-2 must be a doctor or pharmacist qualified in medical biology or must meet the conditions of practice laid down in Article L. 6213-2 or L. 6213-2-1. Depending on the activity for which they are approved, they must also have specialised training and specific experience, deemed sufficient in the light of the assessment criteria defined by the Agence…

I. – Approval for the practitioners mentioned in Article L. 2131-4-2 is granted by the Director General of the Agence de la biomédecine for a period of five years. II – The application for approval must be made in accordance with a standard application form, the composition of which is set by the Director General of the Agency. It must be sent to the Director General by registered post with…

Renewal of a practitioner’s accreditation is issued by the Director General of the Agence de la biomédecine. Renewal is subject to an assessment of the practitioner’s activity, in accordance with criteria laid down by the Director General of the Agency after receiving the opinion of the Agency’s Steering Committee. This assessment is carried out on the basis of the activity reports from the establishments in which it has worked during…

The practitioner’s accreditation may be withdrawn in the event of a breach of the legislative and regulatory requirements of this chapter or a breach of the conditions laid down in the accreditation, as well as in the event of insufficient quality of results with regard to the criteria set by the Director General of the Agence de la biomédecine, after obtaining the opinion of the Orientation Board. In an emergency,…

Decisions relating to the accreditation of practitioners and the renewal, suspension and withdrawal of this accreditation are published in the Official Bulletin of the Ministry of Health. The Agence de la biomédecine updates the list of approved practitioners and makes it available to the public.