Guest user Created: Apr 01, 2022 Last commented: Apr 04, 2022

Do we need ISO 13485 if we have IEC 62304?

Do we really need ISO 13485 or is it just icing on the cake? We have to have IEC 62304.

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Kristina Zvonar Brkić Apr 04, 2022

If you are on the EU market then ISO 13485 is mandatory for all manufacturers of medical devices, no matter the type of device. It is stated in Article 8 of the MDR 2017/745 that all manufacturers need to be in compliance with standards that are published by the EU Commission and are called harmonized standards. On that list is more than 300 different standards, but the only standard that covers the quality management system is the ISO 13485:2016/A11:2021.

For more information, see:

EU MDR Article 8 Use of harmonised standards https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

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Apr 01, 2022

Apr 04, 2022

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