ISO TR 12417-2

Description / Abstract: This document provides region-specific information for

— local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;

— changes related to the drug containing part and how they are evaluated by the different local regions.

For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.