CONSOMED

-the conformity of the devices are manufactured, before a device is released -- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; - the post-market surveillance Article 10(10); - the reporting obligations referred to in Articles 87 to 91 are fulfilled; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.