Subsection 1: Provisions relating to medical biology laboratories authorised in France

The application for administrative authorisation provided for in Article L. 6211-2 as it read prior to the entry into force of Order No. 2010-49 of 13 January 2010 as amended relating to medical biology, submitted in the cases described in 1° and 1° bis of III of Article 7 of the said Order, as amended by Law No. 2013-442 of 30 May 2013, shall be sent by registered letter with…

The decision of the Director General of the Regional Health Agency is notified to the interested party by registered letter with acknowledgement of receipt. It will be published in the journal of administrative acts of the department and region in which each of the laboratory’s sites is located.

Each time a change is made to one of the elements listed in Article D. 6221-24, the declaration provided for in the fourth paragraph of Article L. 6211-2 as it read prior to the entry into force of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology must be made to the Director General of the Regional Health Agency, within a period of one month.

Withdrawal of authorisation may be ordered by the Director General of the Regional Health Agency where it has been established, through an inspection carried out pursuant to Article L. 6231-1, that the laboratory is operating under conditions that are dangerous to public health. This decision to withdraw authorisation may only be taken after the head of the laboratory has been given the opportunity to present his observations on the facts…

For the application of 4° and 5° of I ofArticle 7 of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology, at least one examination per family of medical biology examinations shall be accredited, the percentage being calculated on the basis of all the medical biology examinations performed by the laboratory. The medical biology examinations are calculated in accordance with the conditions set out in Article…

The medical biology laboratory shall inform the regional health agency within whose jurisdiction it is located electronically that it has obtained accreditation for the various percentages set out in I ofArticle 7 of Order No 2010-49 of 13 January 2010 as amended relating to medical biology, enclosing a detailed list of the medical biology examinations performed under accreditation.