Module 14 2022

22/03/2022

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).“

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Module 3.2.R USA ● Batch record sheets ● Comparability protocols ● Methods validation EU ● Process validation scheme ● Medical device – EU Declaration of conformity

– Applicant’s Declaration (Class I: EXCEPT IM, ISS, IRSI) – NBOp (NB opinion) on conformity of the device with GSPRs ● Certificates of Suitability ● TSE Certification

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