IceCure Medical Ltd.

Quality Assurance Director: Responsible for: - 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 reporting obligations referred to in Articles 87 to 91 are fulfilled (MDR – Article 88 – Trend reporting; MDR – Article 89 – Analysis of serious incidents and field safety corrective actions).

Clinical Director: Responsible for: -The post-market surveillance obligations are complied with in accordance with Article 10(10); - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

Regulatory Director: Responsible for the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; The reporting obligations referred to in Articles 87 to 91 are fulfilled (MDR – Article 87 – Reporting of serious incidents and field safety; MDR – Article 90 – Analysis of vigilance data and MDR – Article 91 – Implementing acts).