Micro Therapeutics Inc, d/b/a Ev3 Neurovascular

Ensuring 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 Ensuring the post-market surveillance (PMS) obligations in accordance with EU MDR Article 10(10) are complied with in accordance with regulatory requirements Ensuring the reporting obligations for Vigilance and Field Safety Corrective Action Reporting per EU MDR Articles 87 to 91 are fulfilled

Ensuring the technical documentation and the EU Declaration of Conformity (DOC) are drawn up and kept up-to-date Ensuring that the statement in accordance with EU MDR Annex XV Chapter II Section 4.1 is issued for investigational devices