Module 18 2021

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2/9/2021

3 – Analysis of data

• Meta-analysis: is it acceptable to combine results? • Questions to consider: • Were the populations of the different studies similar? • Were the same devices evaluated by the individual studies? • Was the treatment delivered in the same way, over the same period of time? • Were the study designs similar? • Were the same outcomes being evaluated, and were they reported in the same way? • Were the results of all included studies clearly explained? • Were the results of the different studies similar? If not, were reasons for variations explored? Inconsistency of study parameters in a meta-analysis reduces the confid nc of recommendations

Frequency of updates: MDR

• “updated throughout the lifecycle” (Article 61(11)) in accordance with PMCF Plan – at least annually for Class III and implantable devices • Annex XIV Part B, PMCF plan must include “a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer. ” • PMCF report forms part of the clinical evaluation report

See also MDCG 2020-8 Post Market Clinical Follow-up (PMCF) Evaluation Report template

See also MDCG 2020-7 Post Market Clinical Follow-up (PMCF) Plan template

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