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Article R5222-18-3 of the French Public Health Code

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…

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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°…

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Article R5222-18-5 of the French Public Health Code

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…

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Article R5222-19 of the French Public Health Code

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.

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Article R5223-1 of the French Public Health Code

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…

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Article R5223-2 of the French Public Health Code

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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Article R5223-3 of the French Public Health Code

The information contained in each advertisement shall be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the in vitro diagnostic medical device and professionals to appreciate the characteristics and performance of the in vitro diagnostic medical device. Quotations, tables and other illustrations borrowed from medical journals or scientific works, which are used in advertising, are faithfully reproduced and their…

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Article R5223-4 of the French Public Health Code

Where the Director General of the Agence nationale de sécurité du médicament et de produits santé finds that advertising for an in vitro diagnostic medical device, which is not covered by the provisions of Articles R. 5223-5 to R. 5223-11, is being disseminated in a manner contrary to the provisions of Article L. 5223-2 and of this section, the Director General of the Agence nationale de sécurité du médicament et…

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Article R5223-5 of the French Public Health Code

Applications for authorisation to advertise the in vitro diagnostic medical devices referred to in Article L. 5223-3 must be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person on whose behalf the advertising is to be disseminated, by registered letter or by electronic means with acknowledgement of receipt or by delivery against receipt. Each application for authorisation must…

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