AbbVie Inc.

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 technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; 3. The post-market surveillance obligations are complied with in accordance with Article 10(10); 4. The reporting obligations referred to in Articles 87 to 91 are fulfilled;

In the case of investigational devices which are released for clinical use at Lake County, Illinois site, ensures the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. When out of office or otherwise unavailable to perform role, the PRRC with oversight to investigational devices at Ludwigshafen Germany site will be responsible.

In the case of investigational devices which are released for clinical use at Ludwigshafen Germany site, ensures the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. When out of office or otherwise unavailable to perform role, the PRRC with oversight to investigational devices at Lake County Illinois site will be responsible.

Ensuring 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. Ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. Ensuring the post-market surveillance obligations are complied with in accordance with applicable regulations. Ensuring the reporting obligations are fulfilled in accordance with applicable regulations.