Post-Market Clinical Follow-up under Regulation (EU) 2017/745 on medical devices: Regulatory and statistical considerations

Evnia news

This article by Kyriaki Antonopoulou, Vicky Valla, Ph.D., Amy Lewis, Bassil Akra and Efstathios Vassiliadis discusses aspects of sample size preparation within PMCF and provides three sample size calculation examples.

Proactive, continuous collection of clinical data to feed the clinical evaluation of medical devices as per the requirements of Regulation (EU) 2017/745 can be a burdensome process for manufacturers. Post-Market Clinical Follow-up PMCF activities are intended to confirm safety and performance throughout the expected lifetime of medical devices and to identify real-world misuses. There are various sources of clinical data, including PMCF clinical investigations, surveys, use of registries and hospital databases, as well as literature reviews. The manufacturer will have to make a choice about the level of required factual evidence and the effort needed to collect it, so that it does not jeopardize the clinical development of the medical device. Within this context, several statistical considerations must be considered, with sample size estimation being the most important as samples smaller than required may prevent data extrapolation, whereas unnecessarily large samples could amplify detection of differences due to clinically irrelevant, statistical differences.

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