Responsibilities as per Article 15 of IVDR including:
- ensuring the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
- ensuring the post-market surveillance obligations
- ensuring the reporting obligations are fulfilled.
Masqué
HAMILTON-MCFARLANE Lyn
Responsibilities as per Article 15 of IVDR including:
- ensuring 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.