ISO 13485

ISO 13485:2016

The Medical Devices standard ISO 13485:2016 is currently in limbo and not likely to be updated until 2026.

Usually, ISO standards are subject of revision by a specific technical committee every 5 years. However, from 3 to 5 years is the period from which a revision of the ISO 13485:2016 will probably occur by the ISO TMB (Technical Management Board).

One of the issue to address is that the current ISO 13485 standard does not adhere to the so-called ISO High Level Structure (HLS). This is a structure of ISO standard that should apply to all the ISO Management System Standards.

There are of course other reasons why there is the necessity to start a revision of the current ISO 13485:

– The new EU MDR and EU IVDR, with the related annexes of the ISO 13485 which should be updated.

– Alignment with MDSAP regulation.

September 15, 2021

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