SODIT

(a) the conformity of the devices (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.