Lyv Healthcare

(a) the conformity of the devices is appropriately checked, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) for investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Backup PRRC: (a) the conformity of the devices is appropriately checked before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) for investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.