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

I. – Advertising for the devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 means any form of information, including canvassing, canvassing or inducement that is intended to promote the prescription, supply, sale or use of these devices, with the exception of information provided as part of their duties by pharmacists managing an in-house pharmacy. II –…

The advertising defined in Article L. 5213-1 relates to the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 which have the EU declaration of conformity provided for in Article 19 of that Regulation. Advertising shall objectively define the device and, where applicable, its performance and compliance with general safety and performance requirements, as attested by the declaration…

Medical devices and their accessories that are reimbursed or financed, even partially, by compulsory health insurance schemes may not be advertised to the public, with the exception of medical devices and accessories presenting a low risk to human health, the list of which is set by order of the ministers responsible for health and social security.

The advertising of certain medical devices and their accessories which present a significant risk to human health and whose list is set by order of the Minister for Health is subject to prior authorisation issued by the Agence nationale de sécurité du médicament et des produits de santé. This authorisation is issued for a renewable period of five years. This authorisation may be suspended or withdrawn by reasoned decision of…

The Agence nationale de sécurité du médicament et des produits de santé and the administrative authority referred to in II of Article L. 5211-2, within their respective areas of competence, may, under the conditions set out in Article L. 5312-4-1, give formal notice to the person concerned to withdraw the advertising, to present their observations and to rectify the situation, if necessary by imposing a fine on the formal notice….

The procedures for applying this chapter shall be laid down by decree in the Conseil d’Etat.