(1)Before the product is released, conformity verification of the device has been carried out in accordance with the quality management system under which the device is manufactured.
(2)The technical documentation and the EU declaration of conformity have been drawn up and kept up to date.
(3)The post-market surveillance obligations are complied with in accordance with IVDR Article 10(9).
(4)The reporting obligations set out in IVDR Articles 82 to 86 are fulfilled.
Masqué
Cartographie de Yunnan Rare Biological Products Co., Ltd