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French Public Health Code

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Article L5213-2 of the French Public Health Code

November 6, 2023

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…

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Article L5213-3 of the French Public Health Code

November 6, 2023

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.

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Article L5213-4 of the French Public Health Code

November 6, 2023

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 This authorisation may be suspended or withdrawn by reasoned decision of…

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Article L5213-5 of the French Public Health Code

November 6, 2023

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….

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Article L5221-1 of the French Public Health Code

November 6, 2023

I.-The placing on the market, putting into service and making available on the market of in vitro diagnostic medical devices and their accessories shall comply with the provisions of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 and with the provisions of this Title. II.-In vitro diagnostic medical device means: any medical device which consists of a reagent, reagent product, calibration material, control…

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Article L5221-2 of the French Public Health Code

November 6, 2023

I.-Without prejudice to the provisions of II, the Agence nationale de sécurité du médicament et des produits de santé has the status of competent authority for the implementation of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, under the conditions specified by the provisions of this Part. In this capacity, the agency shall in particular: 1° The tasks provided for at the stage…

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Article L5221-3 of the French Public Health Code

November 6, 2023

I.-The devices referred to in Article 1 of Regulation (EU) 2017/746 shall be placed on the market or put into service in accordance with Article 5 of that Regulation and this Article. II.-Pursuant to Article 54 of Regulation (EU) 2017/746, the Agence nationale de sécurité du médicament et des produits de santé may, upon duly justified request, by way of derogation from the obligation for prior assessment of the conformity…

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is a Registered Trademark of
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75001, Paris France
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75001, Paris France
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Paris Bar Registration n° (Toque) C2396

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