EN ISO 13485:2016/A11:2021 modifies the European standard EVS-EN ISO 13485:2016.
EVS-EN ISO 13485 specifies requirements of a quality management system for medical devices. The main text and the consolidated version which consists of main text and the amendment can be found from the standard’s history.
EVS-EN ISO 13485:2016/A11:2021 supports the requirements of EU Regulations. The relationship with EU Regulations can be found in informative annexes.
In this amendment you can find:
— Annex ZA which covers the relationship between EVS-EN ISO 13485 and the and the requirements of Regulation (EU) 2017/745.
— Annex ZB which covers the relationship between EVS-EN ISO 13485 and the requirements of Regulation (EU) 2017/746.