Module 18 - Drug Device Combinations and Other Technologies

13/12/2023

Clinical Investigations:

“Similar” (predicate) products CE marked

• In-vitro/in vivo data may be sufficient • But needs to be fully justified • Risk evaluation

• Observational data in humans • Claims in ‘Instructions for Use’ - consistency of approach?

The Organisation for Professionals in Regulatory Affairs

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Clinical Investigations:

Devices containing a “New active” substances

• More robust data needed • Pre-clinical studies important • Clinical studies required

The Organisation for Professionals in Regulatory Affairs

40

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