Authorization of centers and facilities
Published on 28 March 2025
Genetic character tests may only be carried out in medical biology establishments and laboratories authorized by the Regional Health Agencies, after consultation with the Agence de la biomédecine, in accordance with article L. 1131-2-1 of the French Public Health Code. Prenatal and preimplantation diagnosis activities are also subject to specific authorizations issued to multidisciplinary prenatal diagnosis centers and preimplantation diagnosis centers, in accordance with article R. 2131-22-2 and article L. 2131-1 of the French Public Health Code. On this page, you will find models for authorization applications, lists of authorized centers and establishments, and applicable agreements.
Authorization of establishments or laboratories to perform genetic diagnosis
Examinations to determine a person's genetic characteristics for medical purposes or identification by genetic fingerprinting include :
- cytogenetic analyses, including molecular cytogenetic analyses
- molecular genetic analyses. Practitioners are accredited directly by the Agence de la biomédecine.
Request for authorization
Authorized establishments
The list of authorized establishments or laboratories has been drawn up on the basis of information supplied by regional health agencies, and is regularly updated.
Authorization of preimplantation diagnostic centers
Preimplantation diagnosis includes the following activities:
- Cell sampling of the embryo obtained by in vitro fertilization;
- Cytogenetic tests, including molecular tests on the embryonic cell(s);
- Molecular genetic tests on embryonic cell(s).
Its implementation requires certain conditions, and it is carried out only in establishments specifically authorized by the Agence de la biomédecine (article L. 2131-4 of the CSP).The Agence de la biomédecine's General Management notifies applicants of the decision to authorize or refuse authorization within a maximum period of 4 months from the date of receipt of the complete application file.
The application for authorization is formulated according to a standard file, the composition of which is set by the Agency's General Management.
Request for authorization
**Applications should preferably be sent electronically to the following address:**juridique@biomedecine.mssante.fr (this address may only be used by a healthcare professional).
If you have not received an acknowledgement of receipt from the Legal Department within 72 hours, please contact us at juridique@biomedecine.fr.
Authorized establishments
Authorization for multidisciplinary prenatal diagnosis centers
Authorization for a multidisciplinary prenatal diagnosis center is granted by the Agence de la biomédecine for a period of 5 years. The decision is notified to the applicant within 4 months of receipt of the complete application file.
The application for authorization is drawn up in accordance with a standard file, the composition of which is set by the Agence's Director General.
Request for authorization
**The file should preferably be sent electronically to the following address: ** juridique@biomedecine.mssante.fr (this address can only be used by a healthcare professional)
If you have not received an acknowledgement of receipt from the Legal Department within 72 hours, please contact us at juridique@biomedecine.fr.
Authorized establishments
CPDPN rules of procedure
Establishments or laboratories authorized to perform prenatal diagnosis
Prenatal diagnosis activities may only be carried out in health establishments or authorized laboratories. These activities include (article R.2131-1 of the CSP):
- Cytogenetic analyses, including molecular cytogenetic analyses;
- Molecular genetic analyses;
- Analyses for the diagnosis of infectious diseases, including molecular biology analyses;
- Hematology analyses, including molecular biology analyses;
- Immunology analyses, including molecular biology analyses;
- Biochemistry analyses, including analyses of maternal serum markers.
Authorizations are issued by the Director General of the Regional Health Agency after consultation with the specialized commission of the Regional Health and Autonomy Conference responsible for the health sector, and with the Agence de la biomédecine.
Application for authorization
Applications must be sent to the relevant regional health agency.
Authorized establishments
This list has been drawn up on the basis of information supplied by regional health agencies, and is regularly updated.
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