Datum Dental Ltd.

- 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 (Article 15a) - the post-market surveillance obligations are complied with in accordance with Article 10(10) (Article

• The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. (Article 15b) • The reporting obligations referred to in Articles 87 to 91 of EU MDR 2017/745 are fulfilled. (Article 15d) • In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU MDR 2017/745 is issued. (Article 15e)