Article D6221-14 of the French Public Health Code
October 30, 2023
The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.
The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.
Renewal applications follow the same procedure as initial applications.
The head of the medical biology laboratory holding the authorisation is required to declare without delay to the Minister responsible for health any change relating to the legal rules and technical operating standards of the laboratory included in the authorisation file.
When it is established that the operating conditions of the laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area holding the authorisation are not or are no longer equivalent to those imposed on medical biology laboratories established on French territory, the authorisation is suspended or withdrawn by the Minister for Health after obtaining the opinion of the Director General…
Biological samples transmitted by the medical biology laboratory established in France requesting the performance of the analytical phase are subject to a monitoring procedure making it possible to establish the conformity of the biological samples accepted by the laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area which performs the analytical phase, their identification, the maintenance of their integrity…
The Minister for Health shall maintain and make available to the public a register of medical biology laboratories established in another Member State of the European Union or party to the Agreement on the European Economic Area which have made the declaration provided for in 1° and 2° of Article L. 6221-4 or which have obtained the administrative authorisation provided for in 3° of the same article, as well as…
After submitting their application for accreditation to the French Accreditation Committee, medical biology laboratories in Guadeloupe, French Guiana, Martinique, Mayotte, Saint-Barthélemy, Saint-Martin and Saint-Pierre-et-Miquelon may ask this Committee, at least six months before the foreseeable date of the preliminary visit referred to in Article R. 6221-1, to determine a common period for the preliminary visits of laboratories located within the jurisdiction of the same regional health agency or within the…
I.-Medical biology laboratories shall submit each analytical system they use to an external quality assessment. II.-Each external quality assessment body for medical biology examinations mentioned in Article L. 6221-9 carries out an inter-laboratory comparison of the results obtained and a comparison of results between groups of laboratories using the same techniques. The body also periodically compares the results of each medical biology laboratory with the result obtained by the reference…
I.-The external quality assessment bodies referred to in article L. 6221-9 must meet the following criteria: 1° Competence, in terms of qualifications and experience, to organise quality control campaigns; 2° Independence from manufacturers of in vitro diagnostic medical devices and medical biology laboratories. The conditions of this independence are defined by order of the Minister for Health, after obtaining the opinion of the Director General of the Agence nationale de…
External quality assessment bodies use a coding system to identify the techniques used in the analytical phase of each examination. Where quality control of a medical biology examination is carried out by more than one body, these bodies use a common coding system. The Agence nationale de sécurité du médicament et des produits de santé coordinates the production and updating of this coding. An order of the Minister for Health…
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is a Registered Trademark of
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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