Aspire Pharma Limited

Per Article 15(3) of the EU MDR: to ensure that: (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 (MDR), and Articles 82 to 86 (IVDR) are fulfilled. NOTE: This refers to Vigilance reporting (i.e. serious incident, field safety corrective action, and incident trend reporting);

Per Article 15(3) of the EU MDR: to ensure that (a) 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;

Per Article 15(3) of the EU MDR: to ensure that: (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.