ISO 13485 :2016 : Medical Devices – Quality Management System – Regulatory requirements, is available since the 25th of February 2016.

This standard should be published in national legislation before September 2016.

The working group who has wrote this standard (ISO/TC 210), published in November 2015 a document named « ISO Transition Planning Guidance for ISO 13485 : 2016 ».

This document established a 3 years transition period from the publication date.

For the moment, the standard can be only buy via the ISO website.

The EN ISO version should be published in June 2016 (source : CEN).