For a new device, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at any time and for a period of two years following the declaration provided for in Article R. 5221-35, ask the manufacturer or his authorised representative to provide a report on the experience acquired with this device after it has been placed on the market.
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.
For the purposes of this chapter, army hospitals and the army blood transfusion centre are considered, respectively, as public health establishments and as a blood transfusion establishment. The local reactovigilance correspondent for the army blood transfusion centre is appointed by the director of this centre.
Advertising to the public for an in vitro diagnostic medical device: 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as an in vitro diagnostic medical device; 2° Specifies the date on which it was drawn up or the date of the last modification and includes at least the following information: a) The name or trade reference…
Advertising of an in vitro diagnostic medical device to healthcare professionals is tailored to the target audience. It specifies the date on which it was drawn up or the date of the last modification and includes at least the following information: 1° The name or commercial reference of the in vitro diagnostic medical device; 2° The purpose assigned to the in vitro diagnostic medical device by its manufacturer and for…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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