ISO 13485:2016 Insight: Role of the Organization

by Breda Kearney | May 14, 2019 | Blog , ISO 13485:2016 , |

ISO 13485:2016 Insight: Role of the Organization

ISO 13485:2016 requires the organization to understand what role is plays in the life-cycle of the medical device. It’s important that the organization understands its role so that it can determine what regulatory requirements apply, their level of responsibility regarding safety of the device, reporting requirements and to determine what requirements of ISO 13485:2016 are applicable to the quality management system (QMS). There are four roles in the medical device life-cycle: Manufacturer, Authorized Representative, Importer or Distributor.


  • Legal entity responsible for design and/or manufacture of the medical device and making it available for use under its name
  • Typically includes the following activities design and development, specification development, purchasing, manufacturing, testing, assembly, packaging, labeling, relabeling, packaging, sterilization, installation or rework
  • Responsible for performance safety of the medical device and compliance with all applicable regulatory requirements

Authorized Representative

  • Natural or legal person established within a jurisdiction or country who has received a written mandate form the manufacturer to act on its behalf for specified tasks with regard to the manufacturer’s obligations under that country or jurisdictions legislation
  • Specific tasks may include: Registering a medical device, certifying suppliers and/or managing adverse events


  • The first legal person in the supply chain to make a medical device manufactured in another country or jurisdiction, available in a country or jurisdiction where it is to be marketed
  • Responsible for maintaining the relationships with the regulatory bodies in the region where it is active and for reporting incidents, adverse events or recalls related to the medical device
  • Manage the import of the medical device according to the regulatory requirements of the region where it is distributing the medical device
  • Responsible for ensuring that the medical device is correctly labelled and for maintaining records of distribution


  • Legal person in the supply chain who makes the medical device available to the end user – can include Importers, retailers, distributors and manufacturers who sell the medical equipment
  • Responsible for the selling the medical device, ensuring that the sold product complies with regulations, putting it into actual use and for ensuring that the medical device is correctly labelled
  • Responsible for registering the medical device and maintaining the registration
  • May provide training and maintenance activities
  • Responsible for publishing and communicating correct information about the medical device
  • Maintain records of distribution and for reporting incidents and adverse events or managing recalls related to the medical device

As part of the ISO certification process, ISO auditors will look for evidence that the organization has documented its role in accordance with ISO 13485:2016 Clause 4.1.1.

ISO 13485:2016 does not define a methodology for meeting this requirement but the organization can consider using a matrix format which identifies the applicable regulatory requirements for each jurisdiction or region, role of the organization, and relevant QMS processes, procedures, activities and operations that are required to ensure compliance.

If you would like to learn more about ISO 13485:2016, Comply Guru offer a Free Introduction to ISO 13485:2016 Training Course that can be completed anytime, anywhere.

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