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) 2017/745 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 87 of this Regulation ;

2° Any failure by the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/745, 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 12 of the same Article 10 ;

3° Failure by the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/745 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 lawfully made available on French territory, under the conditions provided for in Article 87(8) of that Regulation ;

4° Any 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) 2017/745 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 putting into service on French territory a medical device or its accessories:

a) Without the EU declaration of conformity having been drawn up in accordance with Article 19 of Regulation (EU) 2017/745;

b) For which the CE marking provided for in Article 20 of Regulation (EU) 2017/745 has been improperly affixed;

c) In the absence of a valid certificate of conformity, drawn up in accordance with Article 56 of Regulation (EU) 2017/745;

d) Not complying with the general safety and performance requirements mentioned in Annex I to Regulation (EU) 2017/745;

6° Placing on the market or putting into service a product not intended for medical use mentioned in Annex XVI to Regulation (EU) 2017/745:

a) Without the EU declaration of conformity having been drawn up in accordance with Article 19 of Regulation (EU) 2017/745;

b) For which the CE marking provided for in Article 20 of Regulation (EU) 2017/745 has been unduly affixed;

c) In the absence of a valid certificate of conformity drawn up in accordance with Article 56 of Regulation (EU) 2017/745;

d) Not complying with the general safety and performance requirements mentioned in Annex I to Regulation (EU) 2017/745 or with the common specifications applicable to it;

7° Importing or making available on the market a device mentioned in Article 1 of Regulation (EU) 2017/745:

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

b) the conditions of storage and transport of which, while the device is under the responsibility of the importer, compromise its conformity with the general safety and performance requirements or do not comply with the conditions laid down by the manufacturer;

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

8° It is an offence for the manufacturer to place a device referred to in Article 1 of Regulation (EU) 2017/745 on the market without having carried out the registration formalities or without updating the information concerning the device, in accordance with the procedures laid down in Article 29(4) of that Regulation;

9° Any failure by the manufacturer, authorised representative or importer of devices referred to in Article 1 of Regulation (EU) 2017/745, 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 31 of the same Regulation;

10° Any failure by the operator to subject a device referred to in Article 1 of Regulation (EU) 2017/745 to the maintenance and quality control obligations provided for under Article L. 5212-1 of this Code;

11° The fact that a manufacturer of medical devices and their accessories, or an agent, as well as any person who engages in the manufacture, distribution or import of medical devices, carries out, causes to be carried out, disseminates or causes to be disseminated an advertisement to the public for medical devices and their accessories, reimbursed, covered or financed, even partially, by compulsory health insurance schemes, with the exception of those on the list mentioned in Article L. 5213-3;

12° The fact, for the manufacturer of a medical device or its accessories or its agent, for a distributor or for an importer of medical devices and their accessories, of producing, having produced, distributing or having distributed 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. 5213-4;

13° The fact that a manufacturer, authorised representative, distributor or importer of a device mentioned in Article 1 of Regulation (EU) 2017/745, carries out, has carried out, disseminates or has disseminated advertising in favour of this device in disregard of the requirements resulting from Article L. 5213-2 of this Code;

14° Any person engaged in the distribution, excluding sale to the public, of devices referred to in Article 1 of Regulation (EU) 2017/745, even on an ancillary basis, failing to make the declaration provided for in 1° of Article L. 5211-3-1;

15° Failure by a custom-made device manufacturer, or its authorised representative, where applicable, to make the declaration provided for in 2° of Article L. 5211-3-1;

16° Any natural or legal person who, on national territory, sterilises devices, systems or kits on behalf of a manufacturer or a person who assembles systems or kits 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 3° of Article L. 5211-3-1;

17° Failure by a manufacturer or authorised representative of devices referred to in Article 1 of Regulation (EU) 2017/745 to have at least one person responsible for ensuring compliance with the regulations, pursuant to Article 15 of that Regulation;

18° For a manufacturer, authorised representative, distributor, importer or user of devices referred to in Article 1 of Regulation (EU) 2017/745 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 of this code, or to disregard the special conditions or restrictions imposed on the basis of article L. 5312-1;

19° Any failure by 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) 2017/745, 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 of this Code;

20° Any failure by a manufacturer of devices referred to in Article 1 of Regulation (EU) 2017/745 to draw up or update the technical documentation provided for in Article 10(4) of that Regulation;

21° Any failure by a manufacturer of devices referred to in Article 1 of Regulation (EU) 2017/745 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 87(1) of that Regulation, in particular by failing to provide it with all the documents required for the risk assessment, in accordance with Article 89(1) and (3) of that Regulation.

22° It is an offence for a manufacturer, authorised representative, distributor, importer or user of devices referred to in Article 1 of Regulation (EU) 2017/745 to continue, in respect of the products concerned, activities that have been the subject of one of the measures provided for in Article 95(4), Article 97(2) and Article 98(1) of that Regulation ;

23° Any failure by 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) 2017/745, to carry out the withdrawal or recall measures ordered pursuant to Article 95(4), Article 97(2) and Article 98(1) of that Regulation ;

24° Failure by manufacturers of medical devices or their agents or by any person involved 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 medical devices under the conditions set out in Article L. 5211-5-1 of this Code.