ReCor Medical, Inc.

• Ensure that 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 • Responsible for the reporting obligations referred to in Articles 87 to 91 are fulfilled o Trend Reporting o Analysis of Vigilance data

• Confirm that the technical documentation and the EU declaration of conformity are drawn up and kept up to-date • Accountable for the PMS obligations (Art 83) are complied with in accordance with Art 10(10) • Ensure in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued • Reporting obligations referred to in Art 87 to 91 are fulfilled o Reporting and analysis of serious incidents and FSCA. o Implementing acts