1. the conformity of the devices is appropriately checked before 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;
5. in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.