Module 18 2021
07/02/2021
Drug Device Combinations (DDCs)
Regulation 2017/745
The Organisation for Professionals in Regulatory Affairs
9
Drug Device Combinations (DDCs)
TWO TYPES • SINGLE INTEGRAL DDC • Supplied pre-filled with the medicinal product
• NON-INTEGRAL • Use for delivery of medicinal product • .. But can be supplied separately
The Organisation for Professionals in Regulatory Affairs
10
5
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