Book IV: Criminal and financial penalties

I.-If the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/745 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 time limits laid…

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) 2017/745 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, is punishable by one…

I.-Placing on the market or putting into service on French territory a medical device or its accessories is punishable by five years’ imprisonment and a fine of 375,000 euros: 1° Without the EU declaration of conformity having been drawn up in accordance with Article 19 of Regulation (EU) 2017/745; 2° For which the CE marking provided for in Article 20 of Regulation (EU) 2017/745 has been improperly affixed; 3° In…

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 it or update the information concerning it, in accordance with the procedures laid down in Article 31 of the same Regulation, shall be punishable by one year’s imprisonment and a fine of €75,000.

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.