Dirigeants et représentants réglementaires de bioMérieux SA
KAUL Manuela
Responsible for ensuring that:
1) The technical documentation and the EU declaration of conformity are drawn up and kept up to date
2) In the case of investigational devices, the statement referred to in Section 4.1 of Annex XIV is issued.
Masqué
CHARBONNIER Pierre
Responsible for ensuring that:
1) The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
2) The post-market surveillance obligations are complied with in accordance with Article 10(9)
3) Reporting obligations in Articles 82 to 86 are fulfilled