Module 18 2021

07/02/2021

Drug-Device Combinations (including ancillary medicinal products)

Helen Erwood / ESPL

The Organisation for Professionals in Regulatory Affairs

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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

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