Chapter II: Vigilance measures

The resale of a second-hand in vitro diagnostic medical device means any transfer of a medical device that is neither new nor refurbished within the meaning of 6° of Article R. 5221-4. The second-hand resale of any in vitro diagnostic medical device on the list provided for in article L. 5222-2 is subject to the prior issue of a certificate, under the conditions defined by this section.

The provisions of this section do not apply when : 1° The device is sold to a manufacturer of an in vitro diagnostic medical device, except where the latter expressly requests this from the reseller; 2° The device comes from a Member State of the European Union or a State party to the Agreement on the European Economic Area and complies with a technical rule that is mandatory for resale…

The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred to in Article L. 6221-1 and that the person responsible meets the quality control obligations defined by Articles L. 6221-9 and L. 6221-10. It mentions the information necessary to identify the in vitro diagnostic medical device, the date on which…

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°…

Notwithstanding the provisions of Article R. 5222-18-4, where the second-hand in vitro diagnostic medical device which is the subject of the transfer has never been put into service, the file consists solely of the following elements: 1° The acceptance report for the in vitro diagnostic medical device by the person responsible for the transfer, except where the transfer takes place before the physical acceptance of the device concerned; 2° A…

The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.