Scope Ophthalmics Limited

The responsibilities of the PRRC are described in Article 15 of EU MDR 2017/745: The conformity of the devices is properly checked, in accordance with the quality management system under which the devices are manufactured before a device is released. The technical documentation and the EU declaration of conformity are drawn up and kept up to date. The post-market surveillance obligations are complied with in accordance with the requirement of the MDR. Reporting obligations are fulfilled.

These assignments indicate primary accountability and do not preclude responsibilities being shared between PRRC: The conformity of devices is properly checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. The post-market surveillance obligations are complied with in accordance with Article 10(10) EU MDR

These assignments indicate primary accountability and do not preclude responsibilities being shared between PRRC: The technical documentation and the EU declaration of conformity are drawn up and kept up to date. The post-market surveillance obligations are complied with in accordance with Article 10(10) EU MDR.The reporting obligations referred to in Articles 87 to 91 EU MDR are fulfilled. In the case of investigational devices Annex XV statement is issued.

These assignments indicate primary accountability and do not preclude responsibilities being shared between PRRC: The conformity of devices is properly checked, in accordance with the quality management system under which the devices are manufactured, before a device is released The post-market surveillance obligations are complied with in accordance with Article 10(10) EU MDR