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EN ISO 13485:2016/A11:2021 Standard

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  Keywords:

#requirements #eu #relationship #can #amendment

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 2026

  Description:

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

  Purpose

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

  Publication

Friday 7th of January 2022

  Amendment

This standard is an amendment for "EN ISO 13485:2016"

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