The Ombu Library, in the ISO 13485:2016 aisle, includes an article on supply chain roles in ISO 13485:2016. It describes the requirement for a company to identify its roles in each regulatory jurisdiction, determine the requirements for each role, and incorporate them into the QMS. As an example, it points out that the definitions of the roles the EU’s MDR are not same as the ISO 13485:2016 definitions.