French Public Health Code
In forceAny health establishment or health cooperation group which uses or supplies medical devices or makes such devices available to its members, as well as any association distributing medical devices at home and appearing on a list drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, must appoint a local materialovigilance correspondent. However, below an activity threshold set by order of the Director General of the Agency, these establishments and associations are authorised to join together to appoint a materialovigilance correspondent common to several establishments or associations.
The correspondent is appointed :
1° For public health establishments, by the director, after consulting the establishment's medical commission ;
2° For private health establishments, by the administrative manager, after consulting the medical conference;
3° In health cooperation groups, by the group administrator;
4° For associations providing treatment for patients, by the director of the association, after consulting the board of directors.
The materials vigilance correspondent for the health cooperation group may be the materials vigilance correspondent for a health establishment which is a member of the group.
The appointment of the correspondent is immediately brought to the attention of the director general of the regional health agency and the regional materialovigilance and reactovigilance coordinator by the establishment or association.
One or more substitute correspondents are appointed under the same conditions in order to ensure the permanence of this function within the establishment or association.
