Call Us + 33 1 84 88 31 00

Book II: Medical devices, in vitro diagnostic medical devices and other products and articles regulated in the interests of public health

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°…

Read More »

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…

Read More »

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.

Read More »

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…

Read More »

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…

Read More »

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…

Read More »

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…

Read More »

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…

Read More »

Contact a French lawyer now

Contact a French Business Lawyer

Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.

Useful links

You have a question in French Business Law?

Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.

All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.