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Full Description

What is BS EN ISO 13485:2016+A11:2021 about?

This international standard sets out regulatory requirements for medical device quality management systems. BS EN ISO 13485:2016+A11:2021 is the 2021 amendment to the standard which comprises new annexes showing the relationship between the clauses of the standard and the requirements of the European medical devices regulations and IVD medical devices regulation.

Who is BS EN ISO 13485:2016+A11:2021 for?

  • Medical device manufacturers and other organizations in the supply chain for medical devices including authorized representatives, importers and distributors
  • Conformity assessment bodies

What does BS EN ISO 13485:2016+A11:2021 cover?

It gives regulatory requirements for quality management systems for medical devices. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.

BS EN ISO 13485 was last revised in 2016 and in 2021 was confirmed for a further 5 years.

Why should you use BS EN ISO 13485:2016+A11:2021?

  • It can help you implement an effective medical device quality management system that consistently produces safe and effective medical devices
  • It can help you demonstrate conformity with regulatory requirements
  • It further harmonizes regulatory requirements between different jurisdictions and thereby decreases the number of unique requirements for individual markets
  • The new annexes enable manufacturers and notified bodies to conduct a gap analysis to identify where attention is needed to supplement the standard to meet new European requirements
  • It enables users to develop their expertise with a medical devices QMS and with regulatory compliance
    It's an effective way to manage risk and improve processes and efficiency
    Ultimately, its use can increase trust in your medical devices and thereby confer some competitive advantage

What's new about BS EN ISO 13485:2016+A11:2021?

This is an amendment to BS EN ISO 13485:2016 which adds annexes mapping the requirements of the European MDR and IVDR against the requirements for quality management systems within each of the regulations. Each regulation has its own annex. Each annex contains three tables. These three tables map out the relationship of the standard with requirements in the regulation on:

  • The general obligations of the manufacturer in Article 10
  • The quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation
  • The quality management system requirements in Annex XI on conformity assessment based on product conformity verification
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Document History

  1. BS EN ISO 13485:2016+A11:2021

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    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Most Recent
  2. BS EN ISO 13485:2016


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  3. BS EN ISO 13485:2012


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  4. BS EN ISO 13485:2003


    Medical devices. Quality management systems. Requirements for regulatory purposes

    • Historical Version
  5. BS EN ISO 13488:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9002

    • Historical Version
  6. BS EN ISO 13485:2001


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001

    • Historical Version
  7. BS EN 46003:1999


    Quality systems. Medical devices. Particular requirements for the application of EN ISO 9003

    • Historical Version
  8. BS EN 46002:1997


    Specification for application of EN ISO 9002 to the manufacture of medical devices

    • Historical Version
  9. BS EN 46001:1997


    Specification for application of EN ISO 9001 to the manufacture of medical devices

    • Historical Version