Module 18 2021

07/02/2021

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

 (specified in the new draft guideline) • “The core precept of this guideline is that the

Competent Authority for the regulation of medicines (CA) will evaluate the device specific aspects of safety and performance relevant to the quality, safety and efficacy of the medicinal product, and that, as applicable, the NB will assess the relevant GSPRs. “

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