28/29 September 2021
In order to adjust to the current EU-Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices EN ISO 13485 will be revised. Many manufacturers of medical devices are certified according to EN ISO 13485 as basis for their management system for the development and production of medical devices. This standard is based on EN ISO 9001 but is tailored specifically to the needs of manufacturers of medical devices and often constitutes the basis for proving compliance with the European requirements. But there are some points in the Directives which are not covered even when applying EN ISO 13485. In the current annexes ZA, ZB and ZC of the standard (then as edition EN ISO 13485-12) the requirements of the different annexes (such as II, V...) of the EU-Directives are opposed to the standard's content in a sort of matrix. A section for comments in the matrix comments on the comparabilities. The standard's foreword also was changed. But the main text of the standard remained unchanged.