Module 14: Design Development and Certification of Medical Devices

17/11/2023

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

41

EEA: Device content of a DDC …who will assess?

(specified in the new guideline) “The core precept of this guideline is that the CA responsible for the regulation of medicines will evaluate the device (part) specific aspects relevant to the quality safety and efficacy (and hence overall benefit/risk determination) of the medicinal product, and that, as applicable, the NB will assess the relevant GSPRs for the device (part).“

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

42

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