A medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area may open a site in France if :
1° The laboratory is accredited by the competent body of the Member State in which it is established;
2° Or the activity linked to this site is covered by an accreditation issued under the conditions mentioned in Article L. 6221-1 and complying with the standards mentioned in Article L. 6221-2.