[6][7] ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices through the three 'Zed' Annexes (ZA, ZB & ZC).
[9] The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998.
The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017.
[11] The Annex ZB harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/746) of 2017.
[12] ISO/TR 24971[13] was published in 2013 by the ISO TC 210 technical committee to provide expert guidance on the application of this standard.