Huma Therapeutics Limited

Primary PRRC for requirements. Ensuring the device conforms to the manufacturers quality system prior to release. Ensuring that technical documentation and the EU documentation of conformity are generated and up-to-date. Fulfillment of the post-market surveillance obligations in accordance with Article 10(10) Fulfillment of reporting obligations referred to in Articles 87 to 91 The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices

Ensuring the device conforms to the manufacturers quality system prior to release. Ensuring that technical documentation and the EU documentation of conformity are generated and up-to-date. Fulfillment of the post-market surveillance obligations in accordance with Article 10(10). And reporting obligations. The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices. Will serve as secondary when the Primary is not available.