Chapter I: Accreditation and quality control

When a medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area and appearing on a list established by order of the Minister for Health, issued after consulting the committee referred to in Article L. 6213-12, carries out the analytical phase of a medical biology laboratory examination begun in France, the conditions for accreditation, authorisation or approval of…

The declaration provided for in the second paragraph of Article L. 6211-2-1, as it stood prior to the entry into force of amended Order No. 2010-49 of 13 January 2010 relating to medical biology, shall be sent by the laboratory to the Minister for Health by registered letter with acknowledgement of receipt. It shall be accompanied by a copy of the accreditation, authorisation or approval issued by the competent authorities…

The head of the medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area shall inform the Minister responsible for health without delay of any suspension or withdrawal of the accreditation, authorisation or approval issued by the competent authorities of the State in which it is established.

At any time, the Minister for Health may request a copy of the laboratory’s valid accreditation, authorisation or approval.

The application for authorisation provided for in the third paragraph of Article L. 6211-2-1, as it read prior to the entry into force of amended Order No 2010-49 of 13 January 2010 relating to medical biology, shall be sent by the laboratory to the Minister for Health by registered letter with acknowledgement of receipt. The application for authorisation must indicate 1° The legal rules and technical operating standards of the…

The application for authorisation must be accompanied, where appropriate, by a copy of the documents representing accreditation, authorisation or approval issued by the competent authorities of the State in which the laboratory has its registered office. The application for authorisation and the attached documents must be accompanied by a certified translation into French.

Applications for authorisation may only be examined if they are accompanied by a complete file. The application is deemed to be complete if, within one month of receipt, the Minister for Health has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents.

The Minister for Health will decide on the application for authorisation after receiving the opinion of the committee referred to in article L. 6213-12. His decision is published in the Journal officiel de la République française. The commission issues its opinion on the application for authorisation on the basis of a report drawn up by an expert chosen by the Minister for Health on the basis of his or her…

The authorisation is issued for a period of five years. It specifies the medical biology tests that the laboratory is authorised to carry out for patients resident in France.

The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.