Subsection 2: Resale of second-hand medical devices

The resale of a second-hand medical device is understood to mean any transfer of a medical device which is neither new nor refurbished within the meaning of 2° of article R. 5211-4. The second-hand resale of any medical device on the list provided for in the third paragraph of article L. 5212-1 is subject to the prior issue of a certificate, under the conditions defined by this sub-section.

The provisions of this sub-section do not apply when: 1° The second-hand medical device is sold to a medical device manufacturer, as defined in 3° of Article R. 5211-4, unless the latter expressly requests this from the reseller; 2° The second-hand medical device comes from a Member State of the European Union or a party to the Agreement on the European Economic Area and complies with a technical rule that…

The certificate drawn up by the person responsible for the transfer of the second-hand medical device certifies that it has undergone regular maintenance in accordance with the provisions of article R. 5212-28 and, where the device is subject to internal or external quality control in application of article R. 5212-27, that its characteristics and performance comply with the acceptability criteria mentioned in 1° of this article. It mentions the information…

The certificate is accompanied by a file containing the following information: 1° The information contained in the register mentioned in 5° of article R. 5212-28 since the acquisition of the medical device by the person responsible for the transfer. When the device is subject to external quality control, the report relating to the maintenance of the performance of the medical device mentioned in article R. 5212-30 must be less than…

By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following elements: 1° The report of receipt of the medical device by the person responsible for the transfer, except where the transfer takes place before receipt of the device concerned; 2° A declaration on their honour by the person…

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