The Medical Devices Introductory Course 2020

Appraisal of clinical data Example 3 NHMRC (Australia)

Proof Level

Evidence obtained from a systematic review of all relevant randomized controlled trials. Evidence obtained from at least one properly designed randomized clinical trial. Evidence obtained from well-designed pseudo randomized controlled trials. Evidence obtained from comparative studies with concurrent controls, cohort studies, case control studies or interrupted time series with a control group. Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group. Evidence obtained from case series, either post-test or both pre- and post-test

I

II

III.1

III.2

III.3

IV

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Overall analysis of the clinical data

• Once clinical data has been gathered and individually analysed, it needs to be brought together as a whole as part of conformity assessment • Typically separate sections in the CER relating to the ERs/GSPRs identified at the scoping stages • Requirement on safety (ER 1 / GSPRs 1 & 5) • Requirement on acceptable benefit/risk profile (ER 1 / GSPRs 1 & 5) • Requirement on performance (ER 3 / GSPR 1) • Requirement on acceptability of side-effects (ER 6 / GSPR 8)

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