Obtaining CE Mark

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.

Here you can find more information:

• EU MDR Article 10 – General obligations of manufacturer - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/

The following articles can be helpful:

• Production and service provision process in ISO 13485 https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/
• How can ISO 13485 help with MDR compliance? - https://advisera.com/13485academy/blog/2020/03/09/how-can-iso-13485-help-with-mdr-compliance/