Module 18 - Drug Device Combinations and Other Technologies
30/11/2023
Examples – multifaceted products Ophthalmics: Corneal collagen crosslinking..
PHOTREXA Viscous
PHOTREXA
KXL system
Device
Software
Drug UVA activated
The Organisation for Professionals in Regulatory Affairs
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Example 1 – regulatory management of a multifaceted product
Complex Class III Medical Device Contains a reservoir of medicinal product Performs in situ treatment.
Contains software that manages the treatment The drug component is licensed separately as a pharmaceutical and is administered via the device during treatment. Drug component cannot be used without the device
The Organisation for Professionals in Regulatory Affairs
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