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Obtaining CE Mark

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Guest user Created:   Jan 25, 2021 Last commented:   Jan 26, 2021

Obtaining CE Mark

Can a product owner who does not own ISO13485 but manufacturer has its ISO13485 apply and obtain CE marking for medical device product"

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jan 26, 2021

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.

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