Shanghai MicroPort EP MedTech Co., Ltd.

1) Ensure to establish, record, implement and maintain the updated and continuously improving quality management system. Before the release, ensure the conformity of the devices is appropriately checked. 2) Ensure the post-market surveillance (PMS) activities compliance with Article 10 (10) in MDR, and ensure the implementation of PMS activities and keep up-to-date. 3) Perform the duties including reporting obligation referred to in Article 87, Article 88, Article 89 and Article 90 in MDR.

1) Ensure the technical documentation and EU declaration of conformity are drawn up and kept up-to-date. 2) For investigational devices, give a statement referred to in Section 4.1 of Chapter II of Annex XV. It should be stated that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.