The Medical Devices Introductory Course 2020

Background

The Conformity Assessment annexes (MDR Annexes IX to XI; MDD Annexes II to VII) do not define the Quality Management System (QMS) requirements in detail. They give outline requirement only. The QMS requirements are specified in detail in the applicable harmonised standard, which is EN ISO 13485.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

3

What is ISO 13485: 2016?

• It is an ISO standard. It is entitled: “Medical devices – Quality management systems – Requirements for regulatory purposes”. • It is the sector-specific version of ISO 9001 (“Quality management systems – Requirements”) • It is the current version of ISO 13485. • It is similar to the previous version which was dated 2003. Annex A of the 2016 version lists the changes.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

4