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CE mark and ISO 13485 for medical device in EU

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Guest user Created:   Jan 02, 2019 Last commented:   Jan 02, 2019

CE mark and ISO 13485 for medical device in EU

Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.
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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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Verlene Law Jan 02, 2019

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/
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Jan 02, 2019

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