Section 2: Financial penalties

The following constitutes a breach subject to a financial penalty:

1° The fact, for the manufacturer of a device mentioned in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or, where applicable, for its authorised representative, having become aware of a serious incident occurring on French territory concerning this device, of failing to notify it to the National Agency for the Safety of Medicines and Health Products in accordance with the procedures and time limits provided for in Article 82 of this Regulation ;

2° Any failure by the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/746, made available on French territory, to immediately inform the National Agency for the Safety of Medicines and Health Products that this device presents a serious risk, in disregard of the second subparagraph of paragraph 11 of the same Article 10 ;

3° Failure by the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/746 or, where applicable, its authorised representative, to notify any corrective safety measure relating to a device made available on French territory, or any corrective safety measure taken in a third country concerning a device that is also lawfully made available on French territory, under the conditions provided for in paragraph 8 of Article 82 of that Regulation ;

4° Failure by the importer or distributor of a device to immediately inform the National Agency for the Safety of Medicines and Health Products, pursuant to Article 13(7) of Regulation (EU) 2017/746 or Article 14(4) of the same Regulation, that the device it has placed on the market, put into service or made available on French territory, presents a serious risk or is a falsified device ;

5° Placing on the market or making available on French territory a device referred to in Article 1 of Regulation (EU) 2017/746:

a) Without the EU declaration of conformity having been drawn up in accordance with Article 17 of Regulation (EU) 2017/746;

b) For which the CE marking provided for in Article 18 of Regulation (EU) 2017/746 has been wrongly affixed;

c) In the absence of a valid certificate of conformity, drawn up in accordance with Article 51 of Regulation (EU) 2017/746;

(d) Not complying with the general safety and performance requirements set out in Annex I to Regulation (EU) 2017/746;

6° Importing or making available on the market a device referred to in Article 1 of Regulation (EU) 2017/746:

(a) Which must be regarded as non-compliant with regard to the checks provided for in Article 13(2) and (4) of that Regulation for importers, and in Article 14(2) of that Regulation for distributors;

(b) Whose storage and transport conditions, while the device is under the importer's responsibility, compromise its compliance with the general safety and performance requirements or do not comply with the conditions laid down by the manufacturer ;

c) Whose storage and transport conditions, while the device is under the responsibility of the distributor, do not comply with the conditions laid down by the manufacturer;

7° It is an offence for the manufacturer to place on the market a device referred to in Article 1 of Regulation (EU) 2017/746 without having carried out the registration formalities or without updating the information concerning the device, in accordance with the procedures laid down in Article 26(3) of that Regulation;

8° Failure by a manufacturer, authorised representative or importer of devices referred to in Article 1 of Regulation (EU) 2017/746, whose registered office is located on French territory, to register the device or update the information concerning it, in accordance with the procedures provided for in Article 28 of the same Regulation;

9° For a manufacturer, agent, distributor or importer of a device referred to in Article 1 of Regulation (EU) 2017/746 to carry out, cause to be carried out, disseminate or cause to be disseminated advertising in favour of a medical device and its accessories subject to prior authorisation when the Agence nationale de sécurité du médicament et des produits de santé has not issued, has refused to issue, has suspended or has withdrawn the authorisation referred to in Article L. 5223-3;

10° The fact that a manufacturer, authorised representative, distributor or importer of a device mentioned in Article 1 of Regulation (EU) 2017/746, carries out, causes to be carried out, disseminates or causes to be disseminated advertising in favour of this device in disregard of the requirements resulting from Article L. 5223-2;

11° Any person who distributes the devices referred to in Article 1 of Regulation (EU) 2017/746, with the exception of sales to the public, even on an ancillary basis, failing to make the declaration provided for in Article L. 5221-4;

12° Any natural or legal person who, on national territory, sterilises devices referred to in Article 1 of Regulation (EU) 2017/746 on behalf of a manufacturer with a view to placing them on the market, or CE-marked devices designed by their manufacturer to be sterilised before use, failing to make the declaration provided for in Article L. 5221-4;

13° Failure by a manufacturer or authorised representative of devices referred to in Article 1 of Regulation (EU) 2017/746 to have at least one person responsible for ensuring compliance with the regulations, pursuant to Article 15 of that Regulation;

14° For a manufacturer, authorised representative, distributor, importer or user of devices, referred to in Article 1 of Regulation (EU) 2017/746, to continue, with regard to the products concerned, activities that have been the subject of one of the suspension or prohibition measures provided for in Articles L. 5312-1, L. 5312-1-1 and L. 5312-2, or to disregard the special conditions or restrictions imposed on the basis of Article L. 5312-1;

15° For a manufacturer or its authorised representative, a distributor or an importer responsible for placing on the market, putting into service, making available on the market or using a device referred to in Article 1 of Regulation (EU) 2017/746, failing to carry out the measures of withdrawal, destruction of the product or dissemination of warnings or precautions for use decided or ordered pursuant to Article L. 5312-3;

16° Any failure by a manufacturer of devices referred to in Article 1 of Regulation (EU) 2017/746 to draw up or update the technical documentation provided for in Article 10(4) of that Regulation;

17° Failure by a manufacturer of devices referred to in Article 1 of Regulation (EU) 2017/746 to cooperate with the National Agency for the Safety of Medicines and Health Products, during investigations carried out following the notification of a serious incident made pursuant to Article 82(1) of that Regulation, in particular by failing to provide it with all the documents necessary for the risk assessment, in accordance with Article 84(1) and (3) of that Regulation ;

18° For a manufacturer, authorised representative, distributor, importer or user of devices referred to in Article 1 of Regulation (EU) 2017/746 to continue, in respect of the products concerned, activities that have been the subject of one of the measures provided for in paragraph 4 of Article 90, paragraph 2 of Article 92 and paragraph 1 of Article 93 of that Regulation ;

19° The fact, for a manufacturer or his authorised representative, a distributor or an importer responsible for placing on the market, putting into service, making available on the market or using a device mentioned in Article 1 of Regulation (EU) 2017/746, of not carrying out the withdrawal or recall measures ordered pursuant to paragraph 4 of Article 90, paragraph 2 of Article 92 and paragraph 1 of Article 93 of this Regulation ;

20° Failure by manufacturers of in vitro diagnostic medical devices or their agents or by any person engaged in their import or distribution, excluding retail sales, to inform the Agence nationale de sécurité du médicament et des produits de santé of a risk of disruption or any disruption in the availability of these in vitro diagnostic medical devices under the conditions provided for in Article L. 5221-7 of this Code.