Failure by manufacturers of medical devices or their agents, or by any person engaged in the manufacture, distribution, import or export, even on an ancillary basis, of medical devices, to make the declaration provided for in article L. 5211-3-1, is punishable by one year’s imprisonment and a fine of €75,000.
Failure by the facilities referred to in Article L. 6322-1 to keep the registers referred to in Article L. 5212-2-1 is punishable by one year’s imprisonment and a fine of €75,000.
Failure by the operator to subject a device mentioned in Article 1 of Regulation (EU) 2017/745 to maintenance obligations and quality controls pursuant to Article L. 5212-1 is punishable by two years’ imprisonment and a fine of €150,000.
The fact that the manufacturer of a medical device or its accessories or its agent, or a distributor or importer of medical devices or their accessories, carries out, causes to be carried out, disseminates or causes 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nationale de sécurité du médicament et des produits de santé has not issued, has refused to issue, has suspended or has withdrawn the…
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) 2017/745, activities that have been the subject of one of the measures provided for in paragraph 4 of Article 95, paragraph 2 of Article 97 and paragraph 1 of Article 98 of this Regulation; 2° Failing to carry out withdrawal or recall measures…
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.
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 following are authorised to investigate and record breaches of the provisions of Title II of Book II of this Part, and of the regulatory measures taken for the application of these provisions: 1° Pharmacist public health inspectors and inspectors from regional health agencies who are pharmacists, under the conditions set out in articles L. 5411-1 to L. 5411-4 ; 2° Inspectors from the Agence nationale de sécurité du médicament…
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is a Registered Trademark of
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75001, Paris France
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