The Medical Devices Introductory Course 2020

Example of a literature flow chart (2)

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Appraisal of clinical data

• According to MEDDEV 2.7.1 rev4, once pertinent data has been identified (Stage 1) it should be appraised (Stage 2) by:

• identifying information contained in each document, • evaluating methodological quality and scientific validity

• determining whether information is relevant to the clinical evaluation • systematically weighting the contribution of each data set to the clinical evaluation • Tools/guidance widely available on how to do this (e.g. CONSORT for RCTs, PRISMA for systematic reviews and meta-analyses, TREND for

nonrandomised controlled trials) • Grading tables are often used

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