Module 18 2021

07/02/2021

EMA Draft Quality Guideline

 If the device is self-certifiable: ● The applicant should submit the results of the assessment of the conformity of the device part with the relevant GSPRs  If the device (when used alone) would require NB assessment: ● the applicant is required to provide an opinion on the conformity of the device with the relevant GSPRs issued by a suitably accredited NB.  Note that “to enable both the assessor and applicant to determine how the NB opinion was formed, avoid duplication of assessment and identify aspects to be considered during the MAA, it is recommended that the NB Opinion is presented as a technical summary report.  A template for this is provided in the EMA Guideline on the quality requirements for drug-device combinations (EMA/CHMP/QWP/BWP/259165/2019)

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Meanwhile… which guidances are relevant for DDCs and where do they come from?

● ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

● ISO: International Organisation for Standardisation

● IMDRF : International Medical Device Regulators’ Forum

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