Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Examples of Devices with ancillary medicinal product / Human Blood Derivatives (Device-Drug Combination)

23

Public

Focus of this Session

Staked-needle Pre-filled Syringe

Drug Eluting Stent

Single integral

Medicinal substance acts with ancillary action to the device

Single integral

Intended exclusively for use in the given combination

Non-reusable

24

12