Chapter I: Legal status of in vitro diagnostic medical devices.

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…

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…

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…

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…

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.

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…

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,…