Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

Drug-Device Combinations (including ancillary medicinal products)

Helen Erwood / ESPL

The Organisation for Professionals in Regulatory Affairs

1

Learning Outcomes

To understand and describe: ● Devices incorporating ancillary medicinal substances ● The role of Notified bodies and Medicines CAs ● The regulatory process for assessment of DDCs ● Post-consultation requirements ● Borderline and classification issues ● MDR related uncertainties

The Organisation for Professionals in Regulatory Affairs

2

1