French Public Health Code
In forceI.-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 affixed;
3° In the absence of a valid certificate of conformity drawn up in accordance with Article 51 of Regulation (EU) 2017/746;
4° Not complying with the general safety and performance requirements mentioned in Annex I of Regulation (EU) 2017/746.
II.-Importing or making available on the market a device mentioned in Article 1 of Regulation (EU) 2017/746 is punishable by five years' imprisonment and a fine of 375,000 euros:
1° Which must 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 ;
2° Whose storage and transport conditions, while the device is under the importer's responsibility, compromise its compliance with the general safety and performance requirements or do not comply with the conditions laid down by the manufacturer;
3° Whose storage and transport conditions, while the device is under the distributor's responsibility, do not comply with the conditions laid down by the manufacturer.
III.The penalties referred to in I and II are increased to seven years' imprisonment and a fine of 750,000 euros where:
1° The device marketed is likely to pose a serious risk to human health;
2° The offences referred to in I and II of this article have been committed by an organised gang;
3° The offences referred to in I and II of this article have been committed on an electronic communication network intended for a non-specified public.
Article L5462-3
French Public Health CodeIn force
Updated 6 Nov 2023
