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Showing 5131–5140 of 48677 articles for “Art. II-9°”
For the devices mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, the list of which is set by decision of the Director General of the Ag…
Certain medical devices for individual use appearing on a list drawn up by order of the ministers responsible for health and social security may be returned to a state of good repair with a view to re…
The natural or legal person responsible for the sale, whether for consideration or free of charge, of a second-hand device included on a list drawn up by decision of the Director General of the Agence…
I. - The following offences are punishable by five years' imprisonment and a fine of €375,000: manufacturing, importing, exporting, transporting, offering, transferring, acquiring, possessing, using i…
The obligations of notification to the National Agency for the Safety of Medicines and Health Products or of information incumbent, under the vigilance exercised over the devices mentioned in Article…
I. - Any failure, in the context of a regulated activity, to comply with the provisions adopted in application of article L. 5132-8 is punishable by five years' imprisonment and a fine of €375,000:1°…
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 condition…
Attempts to commit the offences referred to in articles L. 5432-1 and L. 5432-2 are punishable by the same penalties.
Legal entities held criminally liable, under the conditions set out in article 121-2 of the French Criminal Code, for the offences defined in this chapter shall incur, in addition to the fine set out…
A decree in the Council of State shall specify the procedures for implementing the rules applicable to vigilance exercised over the devices mentioned in Article 1 of Regulation (EU) 2017/746, as well…
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