Section 2: Multidisciplinary centres for prenatal diagnosis

Only centres that have received the authorisation referred to in VIII of Article L. 2131-1, issued by decision of the Director General of the Agence de la biomédecine after consultation with the Agency’s Orientation Council, may be designated as multidisciplinary prenatal diagnosis centres. The duration of the authorisation is five years.

In addition to the responsibilities conferred on them by Articles L. 2131-4 and L. 2213-1, the multidisciplinary centres for prenatal diagnosis are responsible for: 1° To promote access to all prenatal diagnosis activities and to ensure their implementation by constituting a centre of clinical and biological expertise at the service of patients and practitioners ; 2° To give advice and opinions on diagnosis, treatment and prognosis to clinicians and biologists…

The authorisation of a centre, as provided for in article L. 2131-5, is subject to the following conditions: 1° The centre must operate within a public or private health organisation or establishment of collective interest, on a site with an obstetrics unit ; 2° It must form a multidisciplinary team, the composition of which is defined in article R. 2131-12 ; 3° It must carry out all the tasks defined…

Each centre consists of : 1° A team of practitioners comprising at least : a) A doctor practising on the site mentioned in 1° of article R. 2131-11, holding a diploma of specialised studies in gynaecology-obstetrics or an equivalent diploma ; b) A practitioner practising on this site, with training and experience in foetal ultrasound ; c) A doctor practising on this site who holds a diploma in paediatrics or…

The application for authorisation of the multidisciplinary centre for prenatal diagnosis is submitted by the director of the organisation or health establishment within which the centre is set up. It is made using a standard application form, the composition of which is set by the Director General of the Agence de la biomédecine. This application is sent by the director of the organisation or health establishment to the Director General…

The application for authorisation includes the names of the practitioners mentioned in 1° of article R. 2131-12 and the centre’s draft internal regulations.

The Agence de la biomédecine publishes decisions relating to authorisations, renewals, suspensions and withdrawals of these authorisations in the Official Bulletin of the Ministry of Health. It updates the list of authorised multidisciplinary prenatal diagnosis centres and makes it available to the public.

When a multidisciplinary prenatal diagnosis centre authorised in application of Article R. 2131-13 is found to be in breach of the provisions of this chapter, the Director General of the Agence de la biomédecine may, at any time, withdraw the authorisation of this centre after obtaining the opinion of its Steering Committee and informing the Regional Health Agency concerned. In an emergency, the authorisation may, as a precautionary measure, be…

The centre may be consulted either directly by the pregnant woman or the couple where a proven risk has been identified in application of III of article L. 2131-1, or by the attending physician who sends the medical file to the centre. In the latter case, the file must contain the written consent of the pregnant woman or the couple to the attending doctor’s action and a certificate stating that…

The pregnant woman or the couple will, at her request, be heard by all or some of the members of the multidisciplinary team prior to the consultation mentioned below. The centre will suggest additional investigations or seek specialist external advice if it is necessary to support the diagnosis or prognosis. A doctor from the centre will inform the pregnant woman, the couple or the doctor treating them of the possible…