Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Device-Drug combination

FDA examples • “single-entity” combination products Device coated with a metabolic or cellular action inhibitor ● E.g. Nanoparticle devices

The term used is “ Combination Product ” with “Device Primary mode of action”

FDA is unique in having this definition. No equivalent EU definition exists.

The Organisation for Professionals in Regulatory Affairs

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EU Device-drug combinations

• Medical device – primary action • In the EU… the NB is the main regulating body

• Typically Class III devices (highest risk) • QUALITY SYSTEM control • Declared procedures and GSPR checklist • The MANUFACTURER has responsibility for safety and product liability (through the declaration of conformity) • Clinical benefit / risk (efficacy) of the ANCILLARY MEDICINAL SUBSTANCE must be evident

The Organisation for Professionals in Regulatory Affairs

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