Dominion Biologicals Limited

1. 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. 2. The reporting obligations referred to in Regulation (EU) 2017/746 Articles 82 to 86 are fulfilled.

1. Technical documentation and EU declaration of conformity are drawn up and kept up-to-date. 2. Post-market surveillance obligations are complied with in accordance with Regulation (EU) 2017/746 Article 10(9), and Article 78. 3. Performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Regulation (EU) 2017/746 Section 4.1 of Annex XIV is issued.

1. 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. 2. The reporting obligations referred to in Regulation (EU) 2017/746 Articles 82 to 86 are fulfilled.