| Summary: | Post-market monitoring of medical devices by manufacturers and regulatory agencies aids the
identification of novel hazards or increasing trends in the risks associated with devices. This narrative
review estimates the rates of under-reporting of medical device adverse events and explores the
reasons and possible solutions. Incident reports may be presented to the manufacturer or the
regulatory agency spontaneously by consumers, patients, clinicians, or distributors of medical
devices. However, it is evident that reporting does not occur to a great extent, with the rate of
reporting estimated to be as low as 0.5% of all occurrences. The programmes and processes to
increase and support the reporting of adverse events need to be reviewed, with consideration given
to the cost-benefit of increased reporting in relation to the regulator, regulated entities, healthcare
facilities, and professionals, as well as the public.
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