8 September 2021

Revision ISO 13485:2016+A11:2021

The ISO 13845:2016 standard was revised and published by the European standardization bodies CEN and CENELEC in September 2021. The ISO 13485:2016+A11:2021 includes new annexes that align the requirements of the Medical Devices Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation) with specific clauses of the standard.

What has changed?

The annex in ISO 13485:2016+A11:2021 maps the requirements in the MDR and IVDR regulations concerning:

  • The general obligations of the manufacturer in Article 10 (Table ZA1 for MDR and Table ZB1 for IVDR);
  • The requirements for quality management systems in Annex IX concerning conformity assessment based on a quality management system and assessment of technical documentation (Table ZA2 for MDR and Table ZB2 for IVDR).
  • The requirements for the quality management system in Annex XI concerning conformity assessment based on product conformity verification (Table ZA3 for MDR and Table ZB3 for IVDR).
  • The standard was last revised in 2016 and has been confirmed for another five years in 2021.

Why is this change important for you?

Although ISO 13485:2016 is not mandatory for compliance with the EU MDR/IVDR, it is a widely recognized standard to demonstrate compliance with the MDR/IVDR requirement to have a Quality Management System (QMS) implemented. Based on this and the publication of the annex explaining the relationship between the EU MDR/IVDR requirements and the standard, we strongly recommend manufacturers, authorized representatives, importers, and distributors in the EU to apply this standard.

The EN ISO 13485:2016+A11:2021 provides legal requirements for your QMS that ensure a consistent design, development, production, installation and delivery of medical devices.