I.- The medical biology or imaging tests used to assess the risk that the embryo or foetus has a condition likely to affect the progress or monitoring of the pregnancy, mentioned in II of article L. 2131-1 include : 1° Biochemistry tests on maternal serum markers ; 2° Obstetric and foetal ultrasound within the meaning of 1° of III of this article; 3° Genetic tests on free foetal DNA circulating…
I.-At the first medical examination referred to in the second paragraph of article R. 2122-1 or, failing that, during another medical consultation, any pregnant woman is informed by the doctor or midwife of the possibility of undergoing, at her request, one or more of the examinations referred to in I of article R. 2131-1. Unless the pregnant woman objects, she will receive clear information tailored to her personal situation, covering…
I.-The conditions for prescribing and carrying out the examinations referred to in Article R. 2131-1, as defined in this section, may be specified by order of the Minister for Health issued on a proposal from the Director General of the Agence de la biomédecine after obtaining the opinion of the Agence nationale de sécurité du médicament et des produits de santé.
The Minister for Health shall determine by order : 1° On a proposal from the Director General of the Agence de la biomédecine, the recommendations for good practice relating to access, care for pregnant women and couples, and the organisation and operation of multidisciplinary prenatal diagnosis centres for prenatal diagnosis and pre-implantation diagnosis; 2° On a proposal from the Director General of the Agence de la biomédecine and after obtaining…
An order of the Minister for Health specifies the conditions under which : 1° For the purposes of assessing the risk referred to in the first paragraph of I of Article R. 2131-1, doctors or midwives carrying out the examinations referred to in 2° of I of this article transmit to the medical biologists carrying out the examinations referred to in 1° of I of the same article the data…
I.-Practitioners meeting the following cumulative conditions of training and experience are deemed to be able to prove their competence to carry out one or more of the medical biology examinations mentioned in article R. 2131-1 : 1° Be a medical biologist within the meaning of Articles L. 6213-1, L. 6213-2 or L. 6213-2-1; 2° Hold a university degree in the biological specialities relating to prenatal diagnosis, under the conditions specified…
Practitioners who have been approved by the Agence de la biomédecine on the basis of the provisions prior to the entry into force of Law No 2011-814 of 7 July 2011 on bioethics to carry out one or more prenatal diagnostic activities in practice on the date of entry into force of Decree No 2015-245 of 2 March 2015 setting the competence criteria for practitioners working within structures authorised to…
Without prejudice to the conditions defined in 1° and 2° of Article L. 6122-2, the granting or renewal of the authorisation, mentioned in Article L. 2131-1, granted to public health establishments and medical biology laboratories to carry out one or more of the biological activities listed in I and II of Article R. 2131-1, is subject to compliance with the rules laid down in this section of this chapter. These…
In order to obtain the authorisation referred to in Article R. 2131-5-5, the public health establishment or medical biology laboratory must have the equipment necessary to carry out these activities under conditions that guarantee their quality and safety, as defined by the rules of good practice provided for in Article R. 2131-2-2. It must also have a room for interviews with families concerned by prenatal diagnosis.
The authorisation provided for in Article R. 2131-5-5 is issued for a period of seven years, under the conditions laid down in Articles R. 6122-23 to R. 6122-44. However, before taking the opinion of the specialised commission of the Regional Health and Autonomy Conference competent for the health sector, the Regional Health Agency shall, by virtue of 12° of Article L. 1418-1, obtain the opinion of the Agence de la…
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75001, Paris France
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