Article R5222-18-4 of the French Public Health Code
The certificate is accompanied by a file containing the following information: 1° The results of the quality controls mentioned in articles L. 6221-9 and L. 6221-10, carried out during the previous five years, where they related to the in vitro diagnostic medical device that is the subject of the transfer; 2° A report on the measures taken to correct anomalies observed following the external quality controls mentioned in 1°; 3°…