Section 1: Criminal penalties

The following is punishable by a fifth-class fine: 1° For a healthcare establishment, an interhospital syndicate, a health cooperation grouping using in vitro diagnostic medical devices or a blood transfusion establishment mentioned in article R. 5222-10, not to appoint a reactovigilance correspondent or not to communicate the name of this correspondent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé ; 2°…

Repeated offences under article R. 5462-1 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.

Presenting, at scientific or technical meetings, exhibitions or demonstrations, in vitro diagnostic medical devices that do not comply with the provisions of articles R. 5221-10 and R. 5221-14 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 the fine laid down for third class offences.