Chapter I: Legal status of medical devices.

I.-The placing on the market, putting into service and making available on the market of medical devices and their accessories shall comply with the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and with the provisions of this Title. These provisions shall also apply to the groups of products not intended for medical use listed in Annex XVI to the same…

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) 2017/745 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…

I.-The devices referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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 59 of this Regulation, the Agence nationale de sécurité du médicament et des produits de santé may, upon duly justified request, by way…

The economic operators referred to in paragraph 35 of Article 2 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 are required to register under the conditions laid down in Article 31 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…

The reprocessing of single-use devices referred to in Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, their placing on the market and their use are prohibited.

In the interests of public health, decrees issued by the Minister for Health shall, where necessary, lay down specific conditions relating to the supply of the devices referred to in article L. 5211-1.

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 a medical device shall be laid down by regulation. The manufacturers of the medical device or their authorised representatives or any person involved in its import or distribution, excluding retail sales, or, failing this, the Agence nationale de sécurité du médicament et des produits de santé, may…

The procedures for applying this Title, and in particular: 1° The procedures for filing and updating the declarations provided for in Article L. 5211-3-1 ; 2° The procedures for issuing medical devices prescribed in another Member State of the European Union and the procedures for prescribing medical devices with a view to issuing them in another Member State; 3° The conditions under which the sale, resale or use of certain…