Chapter I: Medical devices

The following is punishable by the fine laid down for fifth class offences: 1° For a health establishment, an inter-hospital syndicate, a health cooperation group or an association mentioned in article R. 5212-12, not to appoint a local material vigilance correspondent or not to communicate the name of this local correspondent to the director general of the Agence nationale de sécurité du médicament et des produits de santé ; 2°…

Repeated offences under article R. 5461-1 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.

Presenting medical devices that do not comply with the provisions of articles R. 5211-12 and R. 5211-17 at scientific or technical meetings, exhibitions or demonstrations without displaying a sign clearly indicating that these devices may not be placed on the market or put into service until they have been brought into compliance is punishable by a third-class fine.