Chapter I: Medical devices.

Selling, reselling or using a device referred to in Article 1 of Regulation (EU) 2017/745 or a category of devices without complying with the conditions laid down pursuant to the provisions of 3° of Article L. 5211-6 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.