Chapter II: In vitro diagnostic medical devices.

I.-If the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or, where applicable, its authorised representative, having become aware of a serious incident occurring on French territory, concerning this device, fails to notify the National Agency for the Safety of Medicines and Health Products in accordance with the procedures and deadlines laid down…

Failure by the importer or distributor of a device to immediately inform the Agence nationale de sécurité du médicament et des produits de santé, 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, is punishable by one…

I.-Placing on the market or putting into service on French territory a device mentioned in Article 1 of Regulation (EU) 2017/746 is punishable by five years’ imprisonment and a fine of €375,000: 1° Without the EU declaration of conformity having been drawn up in accordance with Article 17 of Regulation (EU) 2017/746; 2° For which the CE marking provided for in Article 18 of Regulation (EU) 2017/746 has been improperly…

I.-A 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, shall be punishable by one year’s imprisonment and a fine of 75,000 euros. II.-For the manufacturer to place…

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 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nationale de sécurité du médicament et des produits de santé has not issued, has refused to issue, has suspended or has withdrawn the authorisation referred to in Article L….

Selling, reselling or using a device referred to in Article 1 of Regulation (EU) 2017/746 or a category of devices without complying with the conditions laid down pursuant to the provisions of 3° of Article L. 5221-8 of this code is punishable by two years’ imprisonment and a fine of €150,000.

For the criminal offences mentioned in this chapter, natural persons are also liable to the following additional penalties: 1° Display or dissemination of the decision handed down, under the conditions and subject to the penalties provided for in article 131-35 of the Criminal Code ; 2° Temporary or permanent disqualification from exercising one or more professions governed by this Code, from exercising a commercial or industrial profession, from directing, administering,…

Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Criminal Code, for the offences set out in this chapter shall incur, in addition to the fine set out in article 131-38 of the same Code, the penalties set out in article 131-39, 2° to 9° of that Code.

I.-The following is punishable by two years’ imprisonment and a fine of €150,000: 1° Continuing, with regard to the devices mentioned in Article 1 of Regulation (EU) 2017/746 the 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 this Regulation; 2° Failing to carry out the withdrawal or…