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Article L5221-4 of the French Public Health Code

November 6, 2023

The economic operators referred to in paragraph 28 of Article 2 of Regulation (EU) 2017/746 are required to register under the conditions laid down in Article 28 of the same Regulation. In addition, the following are required to declare their activities to the Agence nationale de sécurité du médicament et des produits de santé, under conditions specified by regulation: 1° Any distributor, as defined in paragraph 27 of Article 2…

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Article L5221-6 of the French Public Health Code

November 6, 2023

Given the precautions in use and interpretation that they require, certain self-diagnostic devices mentioned in paragraph 5 of Article 2 of Regulation (EU) 2017/746 and appearing on a list set by order of the Minister for Health issued on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products may only be dispensed on medical prescription.

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Article L5221-7 of the French Public Health Code

November 6, 2023

I.-The criteria for classifying a situation as a risk in the management of a patient’s state of health due to the unavailability of an in vitro diagnostic medical device are laid down by regulation. The manufacturers of the in vitro diagnostic medical device or their agents or any person involved in its import or distribution, excluding retail sales, or, failing this, the Agence nationale de sécurité du médicament et des…

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Article L5221-8 of the French Public Health Code

November 6, 2023

The procedures for applying this Title, and in particular: 1° The procedures for filing and updating the declarations provided for in Article L. 5221-4; 2° The procedures for issuing in vitro diagnostic medical devices prescribed in another Member State of the European Union and the procedures for prescribing in vitro diagnostic medical devices with a view to issuing them in another Member State; 3° The conditions under which the sale,…

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Article L5222-2 of the French Public Health Code

November 6, 2023

The natural or legal person responsible for the sale, whether for consideration or free of charge, of a second-hand device included on a list drawn up by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), must draw up, in accordance with the procedures laid down by decree in the…

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Article L5222-3 of the French Public Health Code

November 6, 2023

The obligations of notification to the National Agency for the Safety of Medicines and Health Products or of information incumbent, under the vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/746, on the manufacturer or, where applicable, his authorised representative, the importer and the distributor, are defined by this Regulation, in particular in Articles 10, 13, 14, 82, 83 and 84. In addition, any healthcare professional…

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Article L5222-4 of the French Public Health Code

November 6, 2023

A decree in the Council of State shall specify the procedures for implementing the rules applicable to vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/746, as well as the organisational procedures of the authorities and bodies concerned.

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Article L5223-1 of the French Public Health Code

November 6, 2023

I. – Advertising for the devices referred to in Article 1 of Regulation (EU) 2017/746 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 –…

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Article L5223-2 of the French Public Health Code

November 6, 2023

The advertising defined in Article L. 5223-1 shall relate to the devices referred to in Article 1 of Regulation (EU) 2017/746 which have the EU declaration of conformity provided for in Article 17 of that Regulation. Advertising shall objectively define the device and, where applicable, its performance and its compliance with the general safety and performance requirements, as attested by the declaration referred to in the previous paragraph, and shall…

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Article L5223-3 of the French Public Health Code

November 6, 2023

The advertising of certain devices mentioned in Article 1 of Regulation (EU) 2017/746, the failure of which is likely to cause a serious risk to health and the list of which is set by order of the Minister for Health, is subject to prior authorisation issued by the National Agency for the Safety of Medicines and Health Products. This authorisation is issued for a renewable period of five years. This…

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is a Registered Trademark of
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75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396

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75001, Paris France
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