CE mark and ISO 13485 for medical device in EU

Answer: In the EU context, the CE mark is part of the conformity assessment procedure, therefore, is actually a priority over ISO13485. Having ISO 13485 is more of a benefit.

As a company dealing with medical devices, being ISO13485 certified could provides an added assurance that the company has a quality management system in place that can ensure the quality, safety and performance of the devices as well as open up more opportunity for exporting of the products.

For more information, please refer to :

Six key benefits of ISO 13485 implementation
https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/