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Can CE agency also recognize the same 13485 standard?

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Guest user Created:   Feb 15, 2021 Last commented:   Feb 17, 2021

Can CE agency also recognize the same 13485 standard?

I assume that CE agency also recognizes the same 13485 standard?

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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 Feb 17, 2021

If I understand your question correctly, you are asking do notify bodies to recognize standard ISO 13485:2016 as a quality management standard. 

According to the MDD, all manufacturers must be in compliance with applicable harmonized standards. Harmonized standards are standards published by the European Commission in the Official Journal of the European Union. On that list, ISO 13485 is the only standard that covers the quality management system. 

Considering the MDR, there is still no list of harmonized standards published that will answer MDR requirements. It is expected that a new list of harmonized standards will be published by May 2021. Therefore, ISO 13485:2016 is still not harmonized to the MDR.

For more information, please see the following articles:

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Feb 15, 2021

Feb 17, 2021