- 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
- the technical documentation and the EU DoC are drawn up and kept up-to-date
- the post-market surv. obligations are complied with in accordance with Article 10(10)
- the reporting obligations referred to in Articles 87 to 91 are fulfilled
- the statement referred to in Section 4.1 of Chapter II of Annex XV is issued