From the MDR point of view, the product owner is responsible for putting the device on the market, he is considered as a manufacturer. Therefore, the product owner is responsible for getting a CE mark for this product.
Taking into account Article 10 – General obligations of the manufacturer, the product owner is obliged to implement a quality management system. He has to adapt his quality management system to his needs. Since he outsources the production, there must be a quality agreement between him and the outsourced company, and appropriate levels of control must be established.