Do we need ISO 13485 if we have IEC 62304?

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/